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News ArchivesRead News
When Caregiving is Not Enough - Finding Good Homecare
Wednesday November 07, 2012
Leah Pavela, LCSW
Today's Caregiver - Home health care, also known as domicilary care, is care provided in one's own place of residence. This can include skilled nursing services, speech-language pathology, physical and occupational therapy, home health aide services, as well as medical social services and the provision of durable medical equipment such as wheelchairs or walkers for use in-home when ordered by a licensed physician. Anyone who has ever looked for home-based care for a loved one comprehends what a daunting experience it can be. Browse through the "home health agencies" section of the phone book and there are an overabundance of listings—some counties have over 200 home care agencies, with new ones opening, closing, and merging weekly. With so many choices, one might assume that the choice would be easy, but in fact it is not. What follows are some tips to consider when considering homecare for a loved one:
Find out if the agency you are considering is licensed and bonded. In the case of a home health agency, this means that the quality of care being provided has been surveyed/accredited by an outside accrediting agency such as Medicare or the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The agency should also be licensed by the state in which it operates. Agency outcomes can be researched by going to www.Medicare.gov and going to their new "home health compare" tool, or calling the Medicare helpline at 1-800-MEDICARE.
In terms of employees, confirm that all home health employees (nurses, physical therapists, home health aides, and social workers) are certified or licensed in the state they are working (regulations may vary by state), in order to ensure they meet minimum requirements to perform their duties. Also important is to make sure that the agency does screenings of employees to ensure that not only do they not have a criminal background, but that they are free of communicable diseases which could affect the compromised immune system of a patient.
Ask what policies are in place to ensure patient confidentiality, and find out how far that policy extends. Many caregivers, particularly ones who arrange for assistance long distance, find themselves frustrated after they arrange for care for a loved one, only to be told that due to HIPAA regulations, the agency cannot provide information on their health status. At the outset of care, make sure of what the company's policy for communication is and ensure that it is noted who may and may not receive information about the patient.
Kathy R. found communication a problem with one home health agency while caring for her stepmother cross- country. She faxed a durable power of attorney right to the home health agency but "they still wouldn't tell me anything!" She states that "especially when you are working from a distance, your hands are tied when there is no communication."
For most people, it is a far better choice to choose a "full service" agency which provides for all their needs (nursing, home health aide, physical therapy) than to pick and choose services from different agencies. This ensures that caregivers are free to communicate amongst themselves on a patient's progress and work collaboratively to resolve any issues, rather than if they are all from different agencies and forced to stab blindly at problems as they arise.
Most patients fare better when they see one or two familiar faces rather than a steady stream of strangers passing through their lives. Find out if the same person will be caring for your loved one, or if they will see a new person on a continual basis. Having one or two familiar caregivers is particularly helpful in the case of people who are confused or frail, as this helps both the patient and caregiver get used to a routine. It also helps the caregiver know what is "normal" for a patient and what is not normal and warrants a call to the doctor. Also important to find out is what will happen should the regular worker call in sick. Will the person be forced to wait for assistance until the next day? Will a substitute come out at the same time? Will the person have to wait for hours until another worker has time in their schedule?
Find out what the procedure is if there is an emergency. Is there always someone on call? Will a patient need to wait until the next business day to speak with someone should an emergency happen after the regularly scheduled service is performed? A good agency should have someone on call 24 hours a day, seven days a week, so urgent matters need not wait until the next scheduled visit.
FINANCIAL RESPONSIBILITY – A reputable agency will not hesitate to address the patient's financial considerations and should provide the patient/caregiver with a written statement explaining what is/is not covered by insurance/Medicare, and what services the patient will be responsible for out of pocket, if any.
Check with friends, your physician, ask people at your place of worship, or attend a support group and ask which home care agencies others are using. One of the best ways to assess how an agency performs in the home is to look past the glossy brochure and ask people how they feel about the service that has been given to their loved ones. Chances are that good or bad, people will be happy to share their experiences.
Many people who look for home care erroneously assume that if their loved one needs assistance in the home, Medicare will cover the service. This is not always the case. Medicare limits itself to "reasonable and necessary part time or intermittent skilled nursing care and home health services," and does not include 24 hour care, services which are limited to "homemaking" services, assistance with transportation, or companion services. Unless a person has a long-term care insurance policy which provides for these services in the home, home care can be cost prohibitive. Although most people prefer to "age in place," there are times that due to financial resources and the availability of finding good, reliable, continuous care, that an assisted living community may be a better choice than in-home care, both financially and for the assurance of the safety and health of a loved one.
As one popular commercial for menswear states, "An educated consumer is our best customer." There is possibly no arena in which this is truer than in the search for good, reliable home health care. Ronnie Thomas, who is a part owner/administrator for a home health agency in Broward County, states that when a person is considering home health care for a loved one, one should make an informed decision and weigh all the options. She believes that first and foremost to remember is that the services the patient is receiving is paid for by insurance (usually Medicare) and since this is money the loved one worked hard for and paid into the system, they are entitled to and deserve good, quality care which puts the patient's needs first, out of the system. "Attentive, kind, quality care from committed professionals who involve the family as much as possible," are things she believes should be insisted on. Kathy R. believes the same. "Compassion and good communication between caregiver, patient, and the home health provider are paramount," she states, and although she has had many sleepless nights worrying about her stepmother's health, she knows that the home health provider she now uses provides her with one less thing over which to worry.
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subset: commoncrawl


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Salty Iguana: "consistently good Mexican food" Top 5 Page for this destination Overland Park Restaurant Tip by jacki13
Overland Park Restaurants: 40 reviews and 42 photos
This is a fairly nice Mexican restaurant. The service is always friendly and efficient. There are 3 locations; 2 in Kansas City and 1 in Lawrence. They consistently serve good food and drinks.
Favorite Dish: A meal at Salty Iguana without iguana dip would be incomplete. It is a mixture of 3 cheeses and a tad bit of spinach - yummy. Also, the smokey nachos are a good appetizer. The Prairie Village Burrito is good and spicey.
Address: 8228 Mission Road
Price Comparison: about average
Phone: 913-381-3888
Price: US$11-20
Rating: 4
Theme: Mexican
Website: http://www.saltyiguana.com
More Restaurants in Overland Park (3)
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Printable PDF
Vendor: Microsoft
Certifications: MCSD
Exam Name: Delivering Continuous Value with Visual Studio 2012 Application Lifecycle Management
Exam Code: 70-498
Total Questions: 95 Q&As
Last Updated: Feb 20, 2017
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Market experts has given a mean price target of $18.07 to Energy Transfer Equity, L.P. (NYSE:ETE) stock. The target price is the mean of all calls released by analysts in First Call poll. They have EPS estimate of $0.24 for the near-term quarter and $0.97 for this year.
Technical View
The technical assessment of Energy Transfer Equity, L.P. En pinpoints that the 50-day moving average of Energy Transfer Equity, L.P. (NYSE:ETE) stock is $17.48, and is trading $-0.67 points away or -3.85% from 50-day moving average of $17.48. It is trading $3.35 or +24.93% off 200-day MA of $13.46.
The 52-week high of Energy Transfer Equity, L.P. (NYSE:ETE) was $25.36 while $4.00 is the low point in the same period. Energy Transfer Equity, L.P. En share price has to rise more than $-8.55 to register a high for 52-weeks or drop +320.25% to make 52-week low. MA should be referred to as moving average.
Without understanding when a stock is over-valued, or too richly priced, a shareholder may miss out on a chance to cash-in on a profit and investment. Worse, a shareholder might close up their position when a price has no direction.
P/E ratio
Energy Transfer Equity, L.P. (NYSE:ETE) P/E ratio is 15.35 while PEG ratio is at 1.36. By overlooking a firm's price-to-earnings ratio, a shareholder could miss out to discover the true value of stocks and end up investing in the wrong stocks. A P/E ratio is a computation of how much investors are wanting to pay for a purchasing an equity relative to the firm's earnings. It is valuable when comparing the equity price of one firm to another trading in the same industry. The P/E ratio is discovered by dividing market value of stock by average earnings per share in a specified period of time, for instance, the past year.
Energy Transfer Equity, L.P. En stock recorded a close of $16.81 in last trading session, which brings it market cap to $17.63B.
1 Chart Pattern Every Investor Should Know
This little-known pattern preceded moves of 578% in ARWR, 562% in LCI, 513% in ICPT, 439% in EGRX, 408% in ADDUS and more...


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Doggy Day Care in Coachman Ridge, Clearwater, FL
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Rover also offers doggy day care in these other Clearwater neighborhoods:
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|Winding Wood
|Windsor Park
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Cash is no longer king for investors seeking an income from their savings
The economic environment is a tough one for investors who need to generate an income from their savings. It is more than three years since the Bank of England first cut interest rates to 0.5 per cent in a desperate attempt to boost Britain's economy following the financial crisis. And it is difficult to see when rates might begin to rise again.
There was little to cheer for income seekers in the minutes of last month's meeting of the Bank's Monetary Policy Committee (MPC). They suggested that the next move is likely to be to increase the monetary policy stimulus currently being administered to the economy. With the eurozone crisis in full swing and Britain now back in recession, the MPC was on the verge in May of adding to its £325 billion quantitative easing (QE) programme.
Inflation may not yet have fallen to the Bank's 2 per cent target but a tightening of monetary policy before 2013 now seems very unlikely — some economists believe we will have to wait until 2015. Even then, a sustained programme of interest rate increases will be required to propel income seekers, currently earning negative real rates, particularly after tax, back into the black.
The cash savings market is in an especially miserable state. With inflation now at 3 per cent, a basic-rate taxpayer needs to earn an annual interest rate of at least 3.75 per cent in order to avoid losing money after the effects of taxation and price rises. For higher-rate taxpayers, the target is 5 per cent (6 per cent for those on the 50 per cent top rate).
Most accounts come nowhere near clearing such hurdles. The average savings account in the UK currently pays just 1.15 per cent a year. A handful of fixed-rate bonds may get you a positive real rate of return but you will have to tie up your cash for several years.
"This is a wake-up call to all who have deposit-based savings," warns Philip Pearson of P&P Invest, an independent financial adviser.
"Inflation will continue way above target and interest rates will remain at historic lows for the remainder of this decade," he says. "Seek an alternative investment strategy to cash, or face the devaluation of your capital against the rise in the cost of living."
But if not cash, where else might investors seeking income look? Traditionally, one answer would have been Government bonds but gilt yields are at an all-time low. Not only is UK Government debt regarded as a safe haven compared to bonds issued in the eurozone, but that £325 bn of QE has skewed the market. Unprecedented demand has pushed up gilt prices and depressed yields.
What about corporate bonds? The debt issued by companies does offer more generous levels of income. That reflects the greater risk of a company defaulting on its borrowing — and investors losing their money — than the Government doing the same.
However, the huge demand for income-generating assets has sent corporate bond prices soaring. Here, too, QE has been an influence, with much of the money issued by the Bank of England and also the European Central Bank ultimately flowing into the corporate sector.
As a result, yields on corporate bonds are at their lowest level for 50 years. In the UK, AA-rated bonds — those judged least risky by credit-rating agencies — now yield a little over 4 per cent compared to the long-term average of 5.5 to 6 per cent. More risky bonds pay extra, but with a correspondingly higher risk to your capital.
If you are prepared to take that risk, the alternative is the stock market, with most investors likely to get equity exposure via a collective fund. Harry Katz, founder of Norwest Consultants, an independent financial adviser, says: "In general terms, [equity] investments move with inflation, but cash does not. A good global equity income fund should form the core of those investments."
There are two reasons why income-seeking investors should focus on equity-income sectors. First, these funds target companies that consistently pay above-average dividends and have a track record of raising them. That enables the funds to pay higher incomes than other collective investment vehicles (and other asset classes, too). You can choose to draw that income or reinvest it in the fund.
The second factor is that companies are only able to consistently deliver on dividends if they are financially robust and well-managed: exactly the holdings investors need during difficult economic times when weaker businesses' vulnerabilities may be exposed.
Dividend-paying companies have tended to outperform during periods of low growth, which is crucial, says Adrian Lowcock of BestInvest, independent financial advisers. "First and foremost, as saver or investor, your goal should be to beat inflation. In that way you can increase the real value of savings and be able to afford the same goods 10, 20 or 30 years down the line."
Currently, UK equity income unit trusts and open-ended investment companies — Oeics — yield anywhere between 4 and 7 per cent (more in a few specialist cases), while investment trusts offer similar levels of income.
On performance, equity income funds appear to have the edge, not only in difficult economic times. Data from the Investment Management Association suggests that they have outperformed conventional UK equity funds over both the past 10 and 20 years, by 4 per cent and 99 per cent respectively.
However, as with all stock market investments, there is a chance of losing money. Those who cannot afford to take that risk, or a long-term view of at least five years, should not invest, no matter the temptation.
Finally, remember that holding assets within an individual savings account (Isa) will at least protect income from additional tax liabilities. You can put £5,640 of cash savings into an ISA in the current tax year but the figure for investments, including bonds and equities is double that, at £11,280.
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text:
from £115 / night help Price for guests, Nights
Number 42 – Home 66041 Cottage
- 2 bedrooms
- 5 sleeps
- min stay varies
Number 42 – Home 66041
- Cottage
- 2 bedrooms
- 5 sleeps
- min stay varies
Cottage / 2 bedrooms / 1 bathroom / sleeps 5
Key Info
- Beach / lakeside relaxation
- Nearest beach 2 km
- Child friendly
- Car not necessary
- No pets allowed
- Private garden
Description from owner
Located in the idyllic village of Strangford on the shores of Strangford Lough, Number 42 is a listed self catering property and accommodates up to 5 people. The accommodation has been extensively renovated in 2009. The rate for your holiday is fully inclusive and includes central heating, electric, bed linen and towels. There is a large south facing rear garden which is fully enclosed with an old stone wall including lockable gates. This is ideal for children as they can play without having to leave the premises giving Mum & Dad a well deserved break! There is also ample room to park your car at the bottom of the garden. Along with this there is a BBQ and garden furniture for your use.
As Number 42 is situated in the village of Strangford you are within walking distance of shops, bars, restaurants and the harbour with its ferry service to Portaferry. Being so close to the village means that you can enjoy a night out and leave the car at home – safe and sound in the
Located in the idyllic village of Strangford on the shores of Strangford Lough, Number 42 is a listed self catering property and accommodates up to 5 people. The accommodation has been extensively renovated in 2009. The rate for your holiday is fully inclusive and includes central heating, electric, bed linen and towels. There is a large south facing rear garden which is fully enclosed with an old stone wall including lockable gates. This is ideal for children as they can play without having to leave the premises giving Mum & Dad a well deserved break! There is also ample room to park your car at the bottom of the garden. Along with this there is a BBQ and garden furniture for your use.
As Number 42 is situated in the village of Strangford you are within walking distance of shops, bars, restaurants and the harbour with its ferry service to Portaferry. Being so close to the village means that you can enjoy a night out and leave the car at home – safe and sound in the secure parking at the rear of the garden!
Further details outdoors
Large rear south facing garden that is fully enclosed and gated. There is also a built in BBQ and garden furniture for guests use. At the rear of the garden there is secure off road parking for up to two cars. At the rear of the garden there is a play park area , swings / slides and football field - ideal for kids!I
Location description from owner
Northern Ireland region
The area enclosed by Downpatrick, Strangford, Ardglass and Tyrella is known as the Lecale District, made famous by Van Morrison in his song Coney Island, which, incidentally is a headline between Ardglass and Killough.
Start this tour in Killyleagh where the castle is the last in Ulster to be continually occupied for the past three decades. Just outside Killyleagh on A22 you pass Delamont Country Park, then you are travelling along the banks of the River Quoile before reaching Downpatrick.
A busy town with many places of interest including The Saint Patrick Centre, the Grave of St Patrick next to the Down Cathedral, the County Gaol in Down County Museum and the Downpatrick Race Course. Heading east from Downpatrick and on the other side of the River Quoile you will find Saul where St Patrick built his first church in Ireland.
Around the coast, lies the picture postcard village of Strangford. It has good restaurants and pubs, and a cosy harbour from where the ferry to Portaferry departs on the hour and half-hour. Heading along the coast towards Ardglass look out for a small carpark (2 miles from Strangford) from where you can see the seals basking on the rocks below.
It is 8 miles from Strangford to Ardglass, one of Northern Ireland's three major fishing ports. Seven castles, a marina and golf course make Ardglass well worth a stop.
3 miles along the coast is the very elegant village of Killough with its charming sycamore lined street. Further along you come to the magnificent, award-winning blue flag beach of Tyrella.
It's hard to believe that Strangford was once situated on the equator. Of course, this was 5-million years ago!! The deposits laid down then and since have shaped the scenery around Strangford into an area of outstanding natural which you will see and enjoy today.
Within 1 mile from Number 42 is Castleward. A National Trust Property set in 332-hectare (820-acre) walled demesne is in a stunning location overlooking Strangford Lough. The mid-Georgian mansion is an architectural curiosity of its time, built inside and out in two distinct styles, Classical and Gothic. The Victorian laundry, playroom, cornmill, leadmine and sawmill give the full flavour of how the estate worked. The grounds encompass woodland and lough-side paths and horse trails, formal gardens, Old Castle Ward, Temple Water and the Strangford Lough Wildlife Centre.
Folklore has it that there are 365 islands in Strangford Lough, one for every day of the year. The Lough is huge - almost like an inland sea. It's the largest sea Lough in the British Isles, covering 150 sq km. It is also a great place for marine life. Three hundred and fifty million litres of water flow in and out of Strangford Lough twice daily so it's perhaps no surprise that it's one of the richest marine environments in Europe.
In the Autumn Strangford Lough comes into its own. Up to 20,000 light bellied Brent Geese - that's three quarters of the world population - arrive in Northern Ireland after making a remarkable 3,000 mile journey from the Arctic Circle.
In Strangford Lough nearly two thousand marine animals and plants have been recorded in and around the Lough - that's almost three quarters of all the species recorded around the Northern Ireland coast. is so big, there's a wealth of wildlife from seals and basking sharks to tens of thousands of birds that make remarkable journeys halfway across the world to get here.
Downpatrick, approx 7 miles from Number 42. is the burial place of the Ireland's Patron Saint. Visit the The St Patrick Centre which is a new and exciting interpretative exhibition which tells the fascinating story of Ireland's Patron Saint. Through Patrick's own words a light is shone on the arrival of Christianity in Ireland and its development through his mission. A series of interactive displays allow visitors to explore how Patrick's legacy developed in early Christian times and reveal the fabulous artwork and metalwork which was produced during this Golden Age. The exhibition also examines the major impact of Irish missionaries in Dark Age Europe - a legacy which remains to this day.
Number 42 in Strangford Village is the ideal location for enjoying a nights Craic. Wheather you decide to cook in or eat out you'll be able to unwind, chill out and enjoy life the way it should be.!!!
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- Great for children of all ages
- No pets allowed
Bed & bathroom
- Bedroom 1: Double Bed
Bedroom 2: 3 Single Beds
- 1 Family bathroom
- Wi-Fi available
- Private garden
- Internet access
- Central heating
- Fireplace
- Cooker
- Fridge
- Freezer
- Microwave
- Toaster
- Kettle
- Dishwasher
- Washing machine
- Clothes dryer
- Iron
- DVD player
- CD player
- Linen provided
- Towels provided
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- Parking
- Secure parking
- Not suitable for wheelchair users
- Check in time:14:00, Check out time:11:00
- If you have any questions about check-in or check-out times, please contact the owner/manager.
- Payment
- This rental can only be paid for online through Holiday Lettings using your credit/debit card or PayPal (never by bank or wire transfer).
- Smoking
- No smoking at this property
- Cancellation policy
View Policy
House rules
Sorry no bookings accepted if under 21 years of age.
No parties we need to respect or neighbours peace & quite.
About the owner
Paul S
- Response rate:
- 100%
- Calendar updated::
- 19 Feb 2017
- Years listed:
- 8
- Based in:
- United Kingdom
- Overall rating:
Languages spoken: English
This Cottage has 2 bedrooms, 1 bathroom and sleeps 5. It's been listed on Holiday Lettings since 22 Jul 2008. Located in Strangford, it has 26 reviews with an overall rating of 5. The average weekly rate varies from £395 to £495.
The Owner has a response rate of 100% and the property's calendar was last updated on 19 Feb 2017.
Map and how to get there
Guest reviews
– based on 26 reviews
26 reviews
- Excellent
- 25
- Very Good
- 1
- Average
- 0
- Poor
- 0
- Terrible
- 0
"Great holiday cottage in a beautiful setting"
Well equipped and cosy cottage in a fantastic location. A few minutes walk to the amenities in the village. It was n't the weather for using the garden but looks like it will be great in the warmer months. Really enjoyed our stay in Strangford and hope to make a return visit soon to finish exploring Castle Ward's stunning grounds and the other side of the lough.
Mike, thank you and hope to see you again soon Paul
"Great week at Number 42"
The owner, Paul, met us at the property and showed us around, also gave us some good tips for eating out. The house is very clean and comfortable and has all the amenities you require. We stayed for a week and when in the house spent most of our time in the extension which has lovely bi-folding doors leading to a good sized garden. There is also off road parking at the end of the garden which is useful. The kitchen is a good size and has everything you need. Overall a very enjoyable week and would definitely stay here again.
"Absolutely delightful place"
We have stayed at No 42 for many years now and it really is home from home. The house is beautiful, location is fantastic for us as it is close to our family, shop, pubs and places to eat all in walking distance and allows us to have great access to all the fantastic surroundings. The secure parking at the back is great, the garden is a great little sun trap on a sunny day. You have everything you need in the property and Paul goes above and beyond to ensure your stay is comfortable from the time you book until you leave. If you want somewhere to stay where you can explore the beautiful surroundings of county down, i would highly recommend it.
"Comfortable, stylish accommodation in the heart of the village"
I stayed at No. 42 with my grown-up children for a New Year break in Strangford and found it the ideal base from which to enjoy the area - and in particular the annual New Year's Day harbour swim. Comfortable, elegant yet modern and superbly equipped, the house has a lovely sunroom with a wood-burning stove where we sat in the evenings when not out enjoying Strangford's hostelries (only a two minute walk away). There's a secure off-road parking space for your car behind the house too. Owners Paul and Claire welcomed us with a roaring fire on a frosty day, and could not have been more helpful.
"Great holiday house in a beautiful area."
This was our second holiday here-we loved being in the cottage and Strangford so much we had to come again. The cottage is charming, characterful and well laid out. A particular benefit to us with our young child was the large,enclosed garden, fantastic sun room and a two minute walk to a children's playground . We received a warm welcome from Paul the owner who even helped to arrange child care with a wonderful child minder so we could have an evening out. There are lots of things to do in the surrounding area, whether visiting one of the beautiful beaches, visiting the aquarium, watching out for seals or visiting one of the country parks and of course it is not too far to go to Belfast either. We would heartily recommend staying here.
"Fabulous House in beautiful village and surrounding area!"
We stayed in May 2014 with 2 young teenagers .The house is absolutely beautiful and very tastefully decorated.We were greeted on arrival by Paul and Claire ,the owners,who couldn't have been more helpful.We were delighted with the house.The downstairs is so bright and spacious and the newly added sunroom with its bifolding doors opening on to a quiet ,secluded garden is just lovely.There is lots to do in the surrounding area -spectacular walks,Castleward,fishing ,golf iin Ardglass and it so close to the mountains of Mourne .Take a trip on the Ferry over to Portaferry and enjoy afternoon tea in the Portaferry Hotel.The Cuan in Strangford is excellent for food and the fish and chip shop next door is really one of the best we have had.The corner shop Duffys has a fab butchers which has had the best steaks we have tasted.A wonderful house and place for a memorable stay!
"sooo relaxing"
super house super place great pubs ,restaurants, castleward national trust house a must see for a great day out,40 mins from Belfast the village itself is a dream and the people are so nice and helpful. The property itself has every thing that you could need,on arrival paul and his wife were very welcoming and had the stovel lit for us as the day we arrived was a little chilly. there is a great garden at the back of the house perfect place to relax,read a book. We had a great time and we will be back.
"Wonderful, relaxing, perfect place to get away from it all."
I stayed there with my husband and 4 kiddies for a long weekend. What a wonderful house. Ok the 4 kids had to share 3 beds but it was like an adventure for them. The house was fully kitted out. We didnt want for anything. The sunroom was my favourite room. So cosy with comfy leather chairs and couch and a solid fuel stove in the centre of it. I can just imagine it lit in the winter time. I loved the decor in the house too. Cute and quaint bits and bobs all over the house. It was spotlessly clean. Also there is a large playground just 2 minutes away from the house with a football pitch and basketball net. You can see it from the bathroom window. The kids and my husband went to it each morning. Gave Mammy a bit of peace!! Strangford lough is a small place but Downpatrick is only 10mins away with everything you need from swimming pool to cinema to food shopping, restaurants, etc. You can get a 5 minute ferry across the lough to portaferry which is another very quaint place to visit. Beautiful surroundings. Makes me want to go back! Anyway i highly recommend No 42. Thanks to the Sharvins for helping us love our visit.
"Simply THE Best"
Wonderful little house, with a surprising amount of room in a beautiful village in Co Down. Have wanted to visit for ages and finally took the plunge. So glad that we did. My wife and I went for a "quiet" trip which ended up as so much more. Lovely walks, beautiful scenery, great pubs and Strangford Lough. The house, especially the fantastic sunroom at the back with the panoramic view of the garden, the log/turf burner and mustn't forget the bbq is a hidden gem. We will definitely be back.
"Hidden Gem!"
We had a great mid week break in No 42 and the weather was vey kind to us just what the doctor ordered! The house is very equipped and the sunroom is great to sit a have a coffee. We walked to Castleward National Trust properly every day. The food in the Cuan is very good with good service and at reasonable prices. We had a couple of drinks in Hole in the Wall pub great cric and only a few yards away. All in all, great house, great location a real gem! Will be back!
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Despite being a woodsy Lodge tucked in the pines, we're far from "middle of nowhere." In fact, we're just minutes from North Conway village, Settlers Green outlet mall, and 5 major ski areas including Cranmore Mountain Resort and Attitash Mountain Resort!
The Four Seasons Lodge has 10 private bedrooms and sleeps 20 comfortably, three bathrooms and an eating area with lots of room for your group. We have been hosting family reunions at the Four Seasons Lodge for more than two decades so you will be sure we've thought of everything!
At Four Seasons Lodge, we'll supply you with all the ingredients for an amazing vacation: room to dance, a karaoke machine for embarrassing yourselves and each other, a fireplace in the living room for sharing stories around, an outdoor grill and picnic table, free WiFi, a foosball table, and a sauna that is never more inviting than after a day on the mountain.
Teena has put together a guide to North Conway especially for you. She has highlighted lots of her favorite spots, hikes and recommendations for relaxing days. Many of Teena's photos are featured as well!
There are 10 private bedrooms and room for 20 to sleep comfortably, three bathrooms and a dining area with room large enough to accommodate any group. We are handicap-friendly, gay-friendly, and we've welcomed family reunions, business meetings, scrapbook groups, rug hooking groups and gatherings of fun friends!
Our Blog topics range from "Things To Do in North Conway" to "North Conway Restaurants with Insanely Good Food" and everything in between! Check them out and Learn More


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This shoe is a bit more narrow than other shoes: if you doubt about which size will fit you well, choose a bigger size. For more info check out our size chart.
Light grey microfiber upper fabric, grey microfiber on the inner. Ergonomic foam insole, soft grape / grey polyurethane sole, grey laces.


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730982 10672133521
In Stock!
This tarantula wall art provides larger-than-life-sized hair-raising Halloween delight! Lifelike and detailed, this spider can be hung on any wall for a dose of frightful fun. Arachnid enthusiasts and kids who love to put the haunt in Halloween will love how spooky it looks! This piece of Halloween décor can't be topped–it's sure to earn more "Yikes" than all the other decorations in the neighborhood put together! Design includes metal keyhole for mounting. Made of resin.
• Lifelike tarantula wall plaque
• Detailed and oversized
• Spooky and realistic Halloween decoration
• Includes metal keyhole for mounting
• Resin
730981 In Stock!
390 - Gifts $25-$50 -
393 - Boys Gifts -
394 - Girls Gifts -
397 - Halloween -
475 - See What's New for Fall - New for Fall
536 - See New Arrivals - Holiday Preview
554 - Spooky Decorations - Halloween Decorations for Kids
677 - Shop all Halloween -
Delivery time estimates do not apply to personalized, large or heavy items (over 20lbs.) that require special shipping, items shipped directly from the manufacturer, or out-of-stock items.
Delivery estimates only apply to the contiguous United States. Saturday, Sunday and national holidays are not considered business days for these estimated transit days.


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The reverse fly is a resistance exercise that targets the muscles of the upper back and shoulders, primarily the posterior deltoids, rhomboids and middle and lower trapezius. To perform the move, stand and hold a dumbbell in each hand. Bend your knees and lean forward from the hips so your back is almost parallel to the floor. Your arms hang down, perpendicular to the ground. Complete the reverse fly by pulling your arms as far up and out away from your torso as you can while keeping a soft bend in the elbows. As you squeeze the shoulder blades together, your back muscles get a workout.
Variations and Proper Execution
The reverse fly may also be performed using a resistance band or a weight-training machine. You can also do one-armed reverse flyes or perform them from a seated position. When using dumbbells, you must make your back nearly horizontal to the floor -- positioning the torso at a 45-degree angle with the floor is not enough to target the rear deltoids of the shoulders.
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- Photo Credit Phil Date/Hemera/Getty Images
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Reviews - 20 at The Kings3
20 Wood Street ,, Swindon, SN1 4AB
Customer Reviews
Our reviews are from genuine LateRooms.com customers. We verify that the customer has stayed before leaving a review.
47% would recommend it to a friend
Customer service
Food quality
Room quality
Slightly noisy
We stayed mid-week in a room overlooking the Main Street, there was a lot of noise outside, which the hotel couldn't control, but maybe some sort of sound roofing could be fitted, secondary glazing.
the room was quite large and clean, the bathroom was massive, but the shower was a let-down, over the bath, low pressure and very short bursts of hot water. Breakfast was included, it was ok, but the bacon although it smelled nice, was a bit dry. If this is midweek, think I will give the weekend a miss
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Lovely hotel with bags of character
The nightclub downstairs (which they go to great lengths to inform of before you book) didn't bother us in the slightest but take ear-plugs if very light background noise really affects you.
Great hotel, clean and beautifully decorated and a really warm welcome. Would not hesitate to go back.
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Old Town Charm
I booked very late & wasn't expecting much, however I was pleasantly surprised.
The staff were very helpful & friendly. The room was clean & well presented, including tea & coffee making facilities, which was much needed after getting back to my accommodation very late. The only negative to my stay was the location - it was directly opposite the extractor fans for the kitchen, so my room was very noisy up until after 11 & once again from 06:30. A bit better with a closed window, but overall, not much of an issue for the price. The breakfast was delicious & with a large choice. It was cooked to order & there was also a variety of fruit, yoghurt, juice and cereal.
The staff were excellent and I was made to feel very welcome. All in all a great stay in a lovely hotel. Thank you
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20 at The Kings
I stayed on a Friday night and was aware that the venue has a disco which runs until 3:00 am at weekends.
I didn't find this a problem and it didn't disturb my sleep. Light sleepers might find tiresome, however. All the staff were helpful and friendly and the breakfast was very nice (lots of choice available, and freshly cooked). A pleasant stay!
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our stay
hotel was clean and tidy...staff were helpful and courteous
Avoid Saturday Night?
At first I thought I had struck lucky, with a nice room in a nice hotel for a nice price.
However, it was a Saturday night, there was an evening disco attended by loud drunken people through to 3am. also between 11pm and 3.40am there were periodic loud thunder-clap like bouts of bangs - according to the staff, next door emptying their bins!
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My Stay at the Kings
Excellent boutique hotel well located and presented beautifully.
Excellant Breakfast. Will be back again.
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Gorilla Zoe ft. Gucci Mane - Waddle
By Burmy | 9 years ago
Artist: Gorilla Zoe
Track: Waddle ft. Gucci Mane
Feat. Gucci Mane
Producer: Luny Tunez
Album: Unreleased
After the disappointing SoundScan totals for Hustlenomics, Welcome to the Zoo, and Back Up n' da Chevy, rumors started to abound that Block Entertainment was dropped from their distribution deal with Bad Boy South and Atlantic Records. On January 2, Big Block (CEO of Block Ent.) shot a video on YouTube clearing the air and stating the rumors were false. To help distance his artists from the fictional tales, Block has leaked Waddle, a previously unreleased track from Gorilla Zoe (featuring fellow ATLien and Atlantic label mate Gucci Mane). Although it didn't make the original cut on Welcome to the Zoo, Zoe's catchy, deep-throated flow and Gucci's boasts about his iced-out Odie would have fit in nicely as a bonus track.
Sample Text - Sample Link
More from Gorilla Zoe
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text:
By (author) Prince, Brian
Format: Paperback
Checking availability...
Prince by Prince, Brian
Book DescriptionThis is the matching folio to his brilliant comeback release feautring 12 tracks. It also includes colour photos. Songs included are: "A Million Days"; "Call My Name"; "Cinnamon Girl"; "Dear Mr. Man"; "If Eye was The In UR Life"; "Illusion, Come, Pimp & Circumstance"; "Life 'O' The Party"; "Musicology"; "On The Couch"; "Reflections"; "The Marrying Kind"; and "What Do you Want Me To Do".
Buy "Prince" book by Prince, Brian from Australia's Online Bookstore, Boomerang Books.
Book DetailsISBN: 9780634087370
(305mm x 229mm x 7mm)
Pages: 112
Imprint: Hal Leonard Corporation
Publisher: Hal Leonard Corporation
Publish Date: 13-Jul-2006
Country of Publication: United States
Other Editions...
Books By Author Prince, Brian
'Prince', Paperback (September 2007)» View all books by Prince, Brian
Features 11 tracks arranged for guitar tab.
» Have you read this book? We'd like to know what you think about it - write a review about "Prince" book by Prince, Brian and you'll earn 50c in Boomerang Bucks loyalty dollars (you must be a member - it's free to sign up!)
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Our customisable footstools are produced upon order. Please contact your store for more details.
fusion footstool, the product is available in fabrics and leathers. As shown, light grey Lux Felt fabric 2310/oak. H35½xW68xD36cm. [fusion - F011]
Article no.: 4065058F0112310
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text: On Tue, 25 Oct 2005, Christopher Kermorvant apparently wrote: > I have a problem with eps graphs when they are included in latex document > (MikTex on XP) : it seems that the graph size in not correct so that axis > titles and ticks labels disappears. Same problem when graphs are open with > gv (for windows) whereas in PDF, everything is OK (I see axis titles and > ticks labels). Is it a known problem ? Are you using dvipdfm? If so, I fixed this problem by centering the figure on the page. E.g., mygraph.writeEPSfile("c:/mydocs/temp.eps",paperformat=pyx.document.paperformat.Letter)


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GxP and cGxP in Bio/Pharmaceutical Industry Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Department of Pharmaceutics KLE University College of Pharmacy BELGAUM – 590010, Karnataka, India E-mail: email@example.com@yahoo.co.in Cell No: 00919742431000 28 March 20111Department of Pharmaceutics
GxP The bio/pharmaceutical industry has created its own language and GxP is one of many acronyms that we all tend to use. While this may seem "elementary" to some of you, many people may not know what this means. G = Good x (variable replaced with Manufacturing, Clinical, Laboratory, Storage, Distribution and Review) P = Practice 2Department of Pharmaceutics28 March 2011
GxP As you can see, GxP is used as short-hand form for referring to the regulations established by the United States Food and Drug Administration which are published in the Code of Federal Regulations. Sometimes people refer to the "GCPs" which specifically regards the rules that govern clinical trials vs. product manufacturing (GMPs) or laboratory regulations (GLPs). Together, these are known collectively as the "predicate rules" that govern a wide spectrum of regulatory obligations across this diverse industry. 3Department of Pharmaceutics28 March 2011
GxP GxP is also where citations emanate from (typically) as regards FDA inspections. When a regulation is cited, the title tells you where it is published. For example: 21 CFR 312.2 Means: 21 = Title 21 CFR = Code of Federal Regulations 312.2 (312 = part and 2 =section) 4Department of Pharmaceutics28 March 2011
Lifecycle Requirements 5Department of Pharmaceutics28 March 2011
GxP "GxP" is a collective term for the Good Practice quality guidelines and regulations used in many fields, encompassing such internationally-recognized standards as GMP, GCP, GLP, GSP, GDP and GRP. GxP guidelines are designed to ensure that products are safe, meet their intended use and, in regulated industries such as drugs, food, medical devices and cosmetics, adhere to quality processes during manufacturing, control, storage and distribution. 6Department of Pharmaceutics28 March 2011
GxP GxP is a general term for Good Practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries.qualitypharmaceutical The titles of these good practice guidelines usually begin with " G ood" and end in " P ractice", with the specific practice descriptor in between. GxP represents the abbreviations of these titles, where x (a common symbol for a variable) represents the specific descriptor. 7Department of Pharmaceutics28 March 2011
Core GXP Information 8Department of Pharmaceutics28 March 2011
Regional Harmonization Initiatives 9Department of Pharmaceutics28 March 2011
GxP 10Department of Pharmaceutics28 March 2011
List of GxP's in Pharmaceuticals 1.GMP – (Good manufacturing Practice) 2.GCP – (Good Clinical Practice) 3.GLP – (Good Laboratory Practice) 4.GSP – (Good Storage Practice) 5.GDP – (Good Distribution practice) 6.GRP – (Good Review Practice) 11Department of Pharmaceutics28 March 2011
Purpose of GxP The purpose of the GxP quality guidelines is to ensure a product is safe and meets its intended use. GxP guides quality manufacture in regulated industries including food, drugs, medical devices and cosmetics. The most central aspects of GxP are: 1. Traceability: the ability to reconstruct the development history of a drug or medical device. 2. Accountability: the ability to resolve who has contributed what to the development and when. 12Department of Pharmaceutics28 March 2011
Regulators 13Department of Pharmaceutics28 March 2011
GMP – (Good Manufacturing Practice) 28 March 2011Department of Pharmaceutics14
What is GMP ? GMP is that part of Quality assurance which ensures that the products are consistently manufactured and controlled to the Quality standards appropriate to their intended use A set of principles and procedures which, when followed by manufacturers for therapeutic goods, helps ensure that the products manufacture will have the required quality. 28 March 2011Department of Pharmaceutics15
Good Manufacturing Practices A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. - Some of the main risks are unexpected contamination of products, causing damage to health or even death - In correct labels on containers, which could mean that patient receive the wrong medicine. - Insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. 28 March 2011Department of Pharmaceutics16
GMP 28 March 2011Department of Pharmaceutics17 QC GMP QA
GMP GMP is the magic key that opens the door of the Quality In matter of GMP, swim with the current and in matter of Quality stand like a rock! 28 March 2011Department of Pharmaceutics18
GMP 28 March 2011Department of Pharmaceutics19 GMP Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use
GMP guidelines GMP as per Schedule "M" GMP as per WHO GMP as per MCA now known as MHRA GMP as per TGA GMP as per US FDA GMP as per ICH guidelines 28 March 2011Department of Pharmaceutics20
GMP guidance documents EU Good Manufacturing Practice (GMP) Guidelines, Volume 4 of "The rules governing medicinal products in the European Union" US FDA current Good Manufacturing Practice (cGMP) for finished pharmaceuticals, 21 CFR, 210 and 211 WHO Good Manufacturing Practices for pharmaceutical products, Annex 4 to WHO Technical Report Series, No. 908, 2003 21Department of Pharmaceutics28 March 2011
GMP GMP in solid dosage forms GMP in semisolid dosage forms GMP in Liquid orals GMP in Parenterals Production GMP in Ayurvedic medicines GMP in Bio technological products GMP in Nutraceuticals and cosmeceuticals 28 March 2011Department of Pharmaceutics22
API Manufacturing Process 23Department of Pharmaceutics28 March 2011
Secondary Manufacturing Dosage Forms 24Department of Pharmaceutics28 March 2011
Secondary Manufacturing Process - Tablets 25Department of Pharmaceutics28 March 2011
Secondary Manufacturing Process – Sterile parenteral for injection 26Department of Pharmaceutics28 March 2011
Packaging 27Department of Pharmaceutics28 March 2011
Packaging 28Department of Pharmaceutics28 March 2011
Packaging 29Department of Pharmaceutics28 March 2011
Biotechnology Manufacturing Process 30Department of Pharmaceutics28 March 2011
Ten Principles of GMP 1.Design and construct the facilities and equipments properly 2.Follow written procedures and Instructions 3.Document work 4.Validate work 5.Monitor facilities and equipment 6.Write step by step operating procedures and work on instructions 7.Design,develop and demonstrate job competence 8.Protect against contamination 9.Control components and product related processes 10.Conduct planned and periodic audits 28 March 2011Department of Pharmaceutics31
Beyond GMP Reduce pollution - Zero discharge Adaptation of environment friendly methods Consideration for better and healthier life tomorrow Consideration of ethics in life One should begin with end in mind otherwise it will be the beginning of the end 28 March 2011Department of Pharmaceutics32
Cost of effective GMP In fact Cost benefits – positive cost benefits of GMP/QA Good plant lay out, Smooth work flows, Efficient documentation systems, well controlled process, good stores lay outs and stores records- These are Good manufacturing practices Reduction in work in process and inventory holding costs Avoidance of cost of Quality failure ( cost of waste, of rework, of recall, of consumer compensation and of loss of company reputation 28 March 2011Department of Pharmaceutics33
Cost / Benefit analysis GMP is not an "On-cost". It is not even "Just free" It is a contribution to profit Good manufacturing Practice is also Good management Practice leading to Good Manufacturing Profit GMP is central and basic and has cost benefits ( not to be considered as extrinsic or imposed upon manufacturing activities) 28 March 2011Department of Pharmaceutics34
Cost / benefit analysis 28 March 2011Department of Pharmaceutics35 Cost of quality = Cost of A – Cost of B- Payback from C = Profit A B C Staff Scrap Improved morale Training Rework Motivation Systems Complaints Faster throughput Documentation Chaos Higher productivity Equipment Lost sales Increased sales Maintenance Recalls lower inventory Calibration Closedown Sampling Testing In process control Validation Auditing
GCP – (Good Clinical Practice) 28 March 2011Department of Pharmaceutics36
What It Is GCP An international ethical & scientific quality standard for designing, conducting, recording & reporting human clinical studies – EU – Japan – US Applies to registration studies that may have an impact on safety & welfare of human subjects 28 March 2011Department of Pharmaceutics37
GCP Participating Parties IRB/Ethics Committee Investigators Sponsor Regulatory Authorities 28 March 2011Department of Pharmaceutics38
GCP Key Documents Investigator Brochure Study Protocol Informed Consent Document 28 March 2011Department of Pharmaceutics39
GCP Principles 1.Studies in accordance with Declaration of Helsinki; consistent with GCP & applicable regulatory requirements 2.Studies initiated & continued only if anticipated benefits outweigh risks 3.Rights, safety & welfare of human subjects take priority over interests of science & society 4.Available non-clinical & clinical info on product adequate to support study 28 March 2011Department of Pharmaceutics40
GCP Principles 5.Studies scientifically sound; described in clear, detailed protocol 6.Study in compliance with IRB/EC approved protocol 7.Medical care given to subjects is the responsibility of qualified medical professional(s) 8.Individuals conducting studies qualified by education, training & experience 9.Freely given informed consent obtained from every subject prior to study participation 28 March 2011Department of Pharmaceutics41
GCP Principles 10.Study information recorded, handled & stored to allow accurate reporting, interpretation & verification 11.Confidentiality of subject records protected in accordance with applicable regulatory requirements 12.Investigational products manufactured, handled & stored in accordance with GCP & used in accordance with approved protocol 13.Systems/procedures implemented to assure quality of study 28 March 2011Department of Pharmaceutics42
IRB/EC Roles & Responsibilities To safeguard study subjects' rights & welfare by: Evaluation/disposition of study proposal Evaluation of proposed subject consent materials Evaluation of emergency use consent methodology Evaluation of investigator qualifications Ongoing review of study progress (at least yearly) Evaluation of proposed subject compensation plans 28 March 2011Department of Pharmaceutics43
IRB/EC Composition & Operations Membership has qualifications & experience to evaluate science, medical aspects & ethics of proposed study – ≥ 5 members – ≥ 1 member whose primary interest in nonscientific – ≥ 1 member independent of institution or study site Written SOPs & records Decisions rendered at announced meetings with quorum in attendance 28 March 2011Department of Pharmaceutics44
IRB/EC Composition & Operations Only members participating in review should vote Investigator may provide info on study, but should not be involved in review or vote Nonmembers with expertise in special areas may be invited to assist with review (but cannot vote) 28 March 2011Department of Pharmaceutics45
IRB/EC Procedures Document group membership & qualifications Schedule meetings & notify members Conduct initial & ongoing review of studies Determine ongoing review frequency Provide expedited review of minor study changes, in accordance with regulatory requirements Specify that no subject should be enrolled in study prior to IRB/EC approval 28 March 2011Department of Pharmaceutics46
IRB/EC Procedures Specify that no deviations from protocol should be initiated without prior IRB/EC approval – Emergency situations require immediate notification of IRB/EC after the fact Specify that Investigator should promptly report: – Protocol deviations – Changes increasing subject risk or study procedures – Serious and unexpected adverse events 28 March 2011Department of Pharmaceutics47
IRB/EC Procedures Notify Investigator promptly of: – Study-related decisions – Reason for decisions – Procedures for appeal of decisions 28 March 2011Department of Pharmaceutics48
IRB/EC Required Records Relevant records maintained ≥ 3 yr after study completion Records available for review by regulatory authorities 28 March 2011Department of Pharmaceutics49
IRB/EC What is Reviewed Investigator Brochure or Report of Prior Investigations Study protocol & amendments Investigator qualifications Informed consent documents, including subject recruiting tools Other written information provided to subjects Subject compensation plans Adverse events Protocol deviations 28 March 2011Department of Pharmaceutics50
IRB/EC When Reviews Occur Prior to study initiation at site At least yearly during study During study, as necessitated by: – Changes in protocol, consent documents, etc. – Changes in study investigator – Reports of serious or unanticipated device-related adverse events At study completion or termination 28 March 2011Department of Pharmaceutics51
Investigator Roles & Responsibilities Qualified to conduct study Have adequate resources to conduct study Provide medical care to study subjects Regular communication with IRB/EC reviewing study Compliance with study protocol Maintenance of investigational product accountability Compliance with study randomization & unmasking procedures Provide informed consent to study subjects 28 March 2011Department of Pharmaceutics52
Investigator Responsibilities Appropriate Qualifications Training & experience demonstrated via: – Medical license – CV – Specialized study training – GCP training If study responsibilities delegated, need a list of qualified persons to whom responsibilities are delegated 28 March 2011Department of Pharmaceutics53
Investigator Responsibilities Adequate Resources Suitable staff & good methods for keeping them apprised Suitable facilities Appropriate patient population – Access to disease or condition – Volume of patients with disease or condition 28 March 2011Department of Pharmaceutics54
Investigator Responsibilities Required Records & Reports Essential regulatory document file(s) – Protocol & amendments – Approved informed consent documents – Product accountability documentation – Investigator qualifications & agreements – IRB correspondence – Study delegation list – Subject screening/enrollment logs – Study monitoring reports – Calibration/maintenance logs – Memos to file 28 March 2011Department of Pharmaceutics55
Sponsor Roles & Responsibilities Study quality assurance Appropriately qualified medical personnel to advise on study Utilization of qualified personnel in study design & operations Study management, data handling & record keeping Investigator selection & training Definition/allocation of study responsibilities 28 March 2011Department of Pharmaceutics56
Sponsor Roles & Responsibilities Facilitation of communications between Investigators Study compensation (investigators and/or subjects) & financing Regulatory authority notification/submission Confirmation of IRB/EC review/approval Investigational product information Investigational product manufacturing, packaging, labeling & coding Investigational product supply & handling 28 March 2011Department of Pharmaceutics57
Sponsor Roles & Responsibilities Record access Ongoing safety evaluation & reporting Serious/unanticipated adverse event reporting Study monitoring Study noncompliance procedures Study termination or suspension notification Study reports 28 March 2011Department of Pharmaceutics58
Sponsor Roles & Responsibilities Sponsor may transfer responsibilities to CRO – Transfer must be documented in writing – Sponsor still has ultimate responsibility for study quality and data integrity 28 March 2011Department of Pharmaceutics59
Study Protocol Components General administrative info Background Study purpose & objectives Study design Subject eligibility requirements How subjects will be treated How safety & efficacy will be assessed Sample size justification & statistical analysis methods 28 March 2011Department of Pharmaceutics60
Study Protocol Components How data will be captured & maintained Monitoring procedures Proposed informed consent document 28 March 2011Department of Pharmaceutics61
Informed Consent Document Components Statement that study involves "research" & product "experimental" (if applicable) Study purpose Number of expected study subjects to be enrolled Study treatment(s) & probability for random assignment Study exams & procedures for duration of trial Subject's responsibilities Foreseeable risks to subject (embryo, fetus, nursing infant) 28 March 2011Department of Pharmaceutics62
Informed Consent Document Components Expected benefits Alternatives procedures or therapies & associated risk/benefit Compensation available in event of study-related injury or sickness Anticipated payments to subject for study participation Anticipated expenses to subject for study participation Statement that participation is voluntary 28 March 2011Department of Pharmaceutics63
Informed Consent Document Components Description of extent to which confidentiality can be assured Commitment to keep subject apprised on new information that may affect subject's willingness to participate in study Contact info for questions re: subject rights; trial- related adverse events Circumstances under which subject's participation may be terminated 28 March 2011Department of Pharmaceutics64
Investigator Brochure What It Is A compilation of clinical & non-clinical data on the product that is relevant to the product's study in humans Necessary for Investigator & IRB/EC review to assess the risks/benefits associated with study 28 March 2011Department of Pharmaceutics65
Investigator Brochure Components Product formulation summary Introduction/background info regarding product & investigational plan Investigational product physical, chemical & pharmaceutical properties & formulation Non-clinical studies Human clinical studies Summary of data & guidance for Investigator 28 March 2011Department of Pharmaceutics66
Good Clinical Practice Reference Documents & Links ICH - E6: Guideline for Good Clinical Practice 21 CFR 50 - Informed Consent 21 CFR 56 - Institutional Review Board http://www.ich.org/cache/compo/276-254-1.html http://www.accessdata.fda.gov/scripts/cdrh/cfdo cs/cfcfr/cfrsearch.cfm http://www.accessdata.fda.gov/scripts/cdrh/cfdo cs/cfcfr/cfrsearch.cfm 28 March 2011Department of Pharmaceutics67
GLP – (Good Laboratory Practice) 28 March 2011Department of Pharmaceutics68
What It Is GLP Describes good practices for non-clinical lab studies that support research or marketing approvals for FDA-regulated products 28 March 2011Department of Pharmaceutics69
GLP General Requirements Appropriately qualified personnel Adequate resources Appropriate procedures for: – Sanitation, health precautions, clothing – Test protocol development, test methods – Data analysis, report development Appropriately qualified study director Quality assurance function 28 March 2011Department of Pharmaceutics70
GLP Facilities Requirements Suitable size, construction, segregation – Animal care – Animal supplies – Test & control products maintained in a secure area – Operating "suite" – Specimen & data storage 28 March 2011Department of Pharmaceutics71
GLP Equipment Requirements Appropriately designed Adequate thru-put capacity Appropriately located Routinely maintained & calibrated 28 March 2011Department of Pharmaceutics72
GLP Standard Operating Procedures Animal room prep Animal care Receipt, ID, storage, handling, mixing & sampling of test & control articles Test system observations Lab tests Handling of moribund or dead animals Necropsy or postmortem exams of animals 28 March 2011Department of Pharmaceutics73
GLP Standard Operating Procedures Collection & ID of specimens Histopathology Data handling, storage & retrieval Equipment maintenance & calibration Transfer, proper placement & ID of animals 28 March 2011Department of Pharmaceutics74
GLP Reagents & Solutions Adequate labeling – Identity – Concentration – Storage requirements – Expiration date 28 March 2011Department of Pharmaceutics75
GLP Test & Control Articles Adequate characterization Proper receipt, storage, distribution When mixed with a carrier, adequate methods to confirm – Mixture uniformity – Article concentration – Article stability 28 March 2011Department of Pharmaceutics76
GLP Study Implementation Written, approved protocol indicating test objectives & methods Study conducted in accordance with protocol Study monitoring to confirm protocol compliance Appropriate labeling of specimens by test system, study, nature & collection date Records of gross findings from postmortems available to pathologist for specimen histopathology 28 March 2011Department of Pharmaceutics77
GLP Study Implementation Standard data capture/recording requirements – Legibility – Permanence – Accountability – Changes 28 March 2011Department of Pharmaceutics78
GLP Records & Reports Final report of results Study records & data methodically archived to facilitate expedient retrieval – Study documents – Raw data – Specimens – Protocols – QA inspections – Personnel training & qualifications – Calibration & maintenance records 28 March 2011Department of Pharmaceutics79
GLP Records & Reports Records retention (shortest of): – ≥ 2 yr after FDA marketing clearance – ≥ 5 yr after data submitted to FDA in support of marketing application – ≥ 2 yr after Sponsor decision not to proceed with marketing application – Wet specimens hold as long as viable Records transferable with written FDA notification 28 March 2011Department of Pharmaceutics80
GLP Facility Disqualification Grounds for disqualification: – Failure to comply with regulations & – Noncompliance adversely affects study validity & – Previous regulatory actions have been unsuccessful in modifying facility operations 28 March 2011Department of Pharmaceutics81
GSP – (Good Storage Practice) 28 March 2011Department of Pharmaceutics82
GSP – (Good Storage Practice) 1.Glossary 2.Personnel 3.Premises and facilities 4.Storage requirements 5.Returned goods 6.Dispatch and transport 7.Product recall 83Department of Pharmaceutics28 March 2011
1. Glossary a.Active pharmaceutical ingredient b.Contamination c.Cross-contamination d.Excipient e.Expiry date f.Labelling 28 March 2011Department of Pharmaceutics84
1. Glossary g. Packaging material h. Pharmaceutical product i. Production j. Retest date k. Storage l. Supplier 28 March 2011Department of Pharmaceutics85
2. Personnel At each storage site (e.g. that of a manufacturer, distributor, wholesaler, community or hospital pharmacy) there should be an adequate number of qualified personnel to achieve pharmaceutical quality assurance objectives. National regulations on qualifications should be followed. 28 March 2011Department of Pharmaceutics86
2. Personnel All personnel should receive proper training in relation to good storage practice, regulations, procedures and safety. All members of staff should be trained in, and observe high levels of, personal hygiene and sanitation. Personnel employed in storage areas should wear suitable protective or working garments appropriate for the activities they perform 28 March 2011Department of Pharmaceutics87
3. Premises and facilities a.Storage areas b.Storage conditions c.Monitoring of storage conditions 28 March 2011Department of Pharmaceutics88
4. Storage requirements a.Documentation: written instructions and records b.Labeling and containers c.Receipt of incoming materials and pharmaceutical products d.Stock rotation and control 28 March 2011Department of Pharmaceutics89
5. Returned goods Returned goods, including recalled goods, should be handled in accordance with approved procedures and records should be maintained. All returned goods should be placed in quarantine and returned to saleable stock only after this has been approved by a nominated, responsible person following a satisfactory quality re-evaluation. Any stock reissued should be so identified and recorded in stock records. Pharmaceuticals returned from patients to the pharmacy should not be taken back as stock, but should be destroyed. 28 March 2011Department of Pharmaceutics90
6. Dispatch and transport Records for dispatch should be retained, stating at least: — the date of dispatch; — the customer's name and address; — the product description, e.g. name, dosage form and strength (if appropriate), batch number and quantify; — the transport and storage conditions. All records should be readily accessible and available on request. 28 March 2011Department of Pharmaceutics91
7. Product recall There should be a procedure to recall from the market, promptly and effectively, pharmaceutical products and materials known or suspected to be defective. 28 March 2011Department of Pharmaceutics92
GDP – (Good Distribution practice) 28 March 2011Department of Pharmaceutics93
GDP – (Good Distribution practice) GDP governs the proper distribution of medicinal products for human use and regulates the movement of products from the manufacturers' premises (or other central point) to the end user (or other intermediate point). 94Department of Pharmaceutics28 March 2011
GDP – (Good Distribution practice) 1.Principle 2.Personnel 3.Documentation 4.Premises and equipment 5.Deliveries to customers 6.Returns 7.Self inspection 8.Provision of information to Member States in relation to wholesale activities 28 March 2011Department of Pharmaceutics95
1. Principle Policy ensures that products released for distribution are of the appropriate quality. In addition to this, the quality system should ensure that the right products are delivered to the right addressee within a satisfactory time period. A tracing system should enable any faulty product to be found and there should be an effective recall procedure. 28 March 2011Department of Pharmaceutics96
2. Personnel He should fulfil his responsibilities personally. Person should be appropriately qualified: although a degree in Pharmacy is desirable, the qualification requirements may be established by the Member State on whose territory the wholesaler is located. 28 March 2011Department of Pharmaceutics97
2. Personnel Key personnel involved in the warehousing of medicinal products should have the appropriate ability and experience to guarantee that the products or materials are properly stored and handled. Personnel should be trained in relation to the duties assigned to them and the training sessions recorded. 28 March 2011Department of Pharmaceutics98
3. Documentation All documentation should be made available on request of competent authorities a.Orders b.Procedures c.Records 28 March 2011Department of Pharmaceutics99
4. Premises and equipment Premises and equipment should be suitable and adequate to ensure proper conservation and distribution of medicinal products. a.Receipt b.Storage 28 March 2011Department of Pharmaceutics100
5. Deliveries to customers Deliveries should be made only to other authorised wholesalers or to persons authorised to supply medicinal products to the public in the Member State concerned. In case of emergency, wholesalers should be in a position to supply immediately the medicinal products that they regularly supply to the persons entitled to supply the products to the public. 28 March 2011Department of Pharmaceutics101
5. Deliveries to customers Medicinal products should be transported in such a way that : a) Their identification is not lost; b) They do not contaminate, and are not contaminated by, other products or materials; c) Adequate precautions are taken against spillage, breakage or theft; d) They are secure and not subjected to unacceptable degrees of heat, cold, light, moisture or other adverse influence, nor to attack by microorganisms or pests. 28 March 2011Department of Pharmaceutics102
6. Returns a.Returns of non-defective medicinal products b.Emergency plan and recalls c.Counterfeit medicinal products d.Special provisions concerning products classified as not for sale 28 March 2011Department of Pharmaceutics103
7. Self inspection Self-inspections should be conducted 9and recorded) in order to monitor the implementation of and compliance with this guideline. 28 March 2011Department of Pharmaceutics104
8. Provision of information to Member States in relation to wholesale activities Wholesalers wishing to distribute or distributing medicinal products in Member State(s). Where appropriate, the competent authorities of this (these) other Member State(s) will inform the wholesaler of any public service obligation imposed on wholesalers operating on their territory. 28 March 2011Department of Pharmaceutics105
Guidance documents deal with GDP WHO Good Distribution Practice, Annex 5 to Technical Report Series, No. 937, 2006 Health Canada Guidelines for Temperature Control of Drug Products during Storage and Transportation, 2005 Irish Medicines Board Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances, 2006 USP chapter Good Storage and Shipping Practice EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) 106Department of Pharmaceutics28 March 2011
GRP – (Good Review Practice) 28 March 2011Department of Pharmaceutics107
GRP – (Good Review Practice) A good review practice (GRP) is a documented best practice within CDER that discusses any aspect related to the process, format, content, and/or management of a product review. GRPs are developed over time as superior practices based on CDER's collective experience to provide consistency to the overall review process of new products. GRPs are developed to improve the quality of reviews and review management. 28 March 2011Department of Pharmaceutics108
GRP – (Good Review Practice) GRPs improve efficiency, clarity, and transparency of the review process and review management. GRPs are expected to be adopted by review staff as standard processes through supervisor mentoring, implementation teams, and formal training when necessary. Developing GRPs is an attempt to identify, collect, enhance, implement, and adopt may of these best practices as documented and standardized GRPs that can be shared among all review division 28 March 2011Department of Pharmaceutics109
− Quality — Consistent implementation of GRPs by review staff will enhance the quality of reviews, the review process, and the resultant regulatory action. − Efficiency — GRPs will improve the efficiency of the review process through standardization. − Clarity — GRPs support clarity throughout the review process, including critical review and decision activities that must be completed before a regulatory decision is made. 28 March 2011Department of Pharmaceutics110 GRPs Fundamental Values
− Transparency — Developing and documenting GRPs ensures that our review processes are readily available in one location via the Internet (through CDER's Web site) to sponsors and the public. − Consistency — By offering a consistent approach and only deviating from it when appropriate (after supervisory concurrence), GRPs help reviewers achieve consistency with their reviews and provide standard review processes across divisions and offices. 28 March 2011Department of Pharmaceutics111
cGxP 28 March 2011Department of Pharmaceutics112
cGxP A "c" or "C" is sometimes added to the front of the acroynm. The preceding "c" stands for "current." For example, cGMP is an acronym for "current Good Manufacturing Practices." cGMP is the most well known example of a GxP. The term GxP is only used in a casual manner, to refer in a general way to a collection of quality guidelines. 113Department of Pharmaceutics28 March 2011
cGxP What does cGxP stand for? Current Good X Practice (FDA compliance; X can mean: Manufacturing, Clinical, Laboratory, Storage, Distribution, Review Pharmaceutical) 114Department of Pharmaceutics28 March 2011
Department of Pharmaceutics115 Thank you Cell No: 00919742431000 E-mail: firstname.lastname@example.com
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by J.R. McConvey
One day in October of 1873, Rev. Moses Harvey opened his front door in St. John's, Newfoundland, to discover that monsters exist.
Before him was a six-metre length of ropy tentacle, severed from a living giant squid. Dusky red and tough as leather, it was about the thickness of a man's wrist. As a man of science, Harvey knew the value of his prize. He would later describe it as "the veritable arm of the hitherto mythical devilfish."
Stories of gigantic sea monsters had been around for centuries, but they were difficult to verify. What had come into Harvey's possession was apparently the first conclusive evidence of the existence of Architeuthis — the giant squid.
The squid was found by local fishermen, who had to put up quite a fight to keep the creature from pulling them under.
A few weeks later, fishermen in a neighbouring community grappled with another giant squid. This one also ended up with Harvey, who was known to take an interest in the creatures.
Harvey measured the squid at about fifteen metres. He had it photographed from an iron crossbar in his sponge bath and later shipped it to a researcher at Yale University. The creature's existence was now scientifically confirmed, and its fame spread worldwide.
While not common, quite a few giant squid were sighted in Harvey's time. Dozens of giant squid were reportedly washed ashore or seen floating on the surface in Newfoundland waters from 1871 to 1881.
Giant squid remain elusive today. It was only a few years ago that an underwater camera captured remarkable footage of the animal.
This article is an abbreviated version of a story that appeared in the August-September issue of Canada's History magazine.
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Who was a servant? Sadistic? Successful? Here are five nasty participants in a pirate-eat-pirate world.
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