The number of FDA warnings to drugmakers and others for questionable drug promotion has nearly doubled since President Barack Obama took office a year ago. The agency sent 41 enforcement letters in 2009 compared with 21 letters in 2008, Thomas Abrams, head of the FDA’s Division of Drug Marketing, Advertising, and Communication, told Reuters.
It has sent nine letters in January — a pace that is expected to continue in 2010, he said in an interview. (That means 2010 will more than double from 2009!)
“We’re trying to get the point across to industry that we want them to comply with the law because it affects public health,” Abrams said. “If you don’t comply with the law, we are going to take action. We are not going to tolerate having consumers or healthcare professionals misled.”
Read the entire article. Go to: www.gmptrainingsystems.com/resources
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GMP Tip
Be prepared for tougher FDA inspections. Conduct internal audits - and then correct any issues identified. Don’t let FDA be your auditor!
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Developing and Deploying a Successful GMP Training Program
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Mar 26
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McNeil Consumer Healthcare, manufacturer of Tylenol and a Johnson & Johnson company, recently conducted a massive recall of Tylenol and other products because of moldy or mildew-like smells traced to a chemical used on wooden pallets used in shipping.
GMP Tip
FDA issued McNeil Consumer Healthcare a Warning Letter on January 15. This follows an FDA-483 issued on January 8. Read both documents. Go to: www.gmptrainingsystems.com/resources
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How to Manage Regulatory Inspections - Part Two: The Inspection Room and the Control (War) Room
Feb 5
Fundamentals of Cleaning and Cleaning Validation
Feb 12
How to Manage Regulatory Inspections - Part Three: Staff Training and Preparation
Feb 19
Effectively Implementing CAPA (Corrective and Preventive Action)
Feb 26
How to Manage Regulatory Inspections - Part Four: Developing an Effective Response to Regulatory Inspections (FDA and EU)
Mar 5
GMP Traiing in Tough Times - Getting it Right!
Developing and Deploying a Successful GMP Training Program
Mar 12
Ten Steps to Reducing Waste in Process Validation
Mar 19
Implementing cGMPs for Dietary Supplements
Mar 26
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GMP Tip
FDA has created a new portal for information that they call FDA Basics. This looks like it’s a good source for information which can enhance your GMP training efforts.
Find it at www.fda.gov/AboutFDA/Basics
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How to Conduct Environmental Monitoring Effectively
Jan 29
How to Manage Regulatory Inspections - Part Two: The Inspection Room and the Control (War) Room
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Fundamentals of Cleaning and Cleaning Validation
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How to Manage Regulatory Inspections - Part Three: Staff Training and Preparation
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Effectively Implementing CAPA (Corrective and Preventive Action)
Feb 26
How to Manage Regulatory Inspections - Part Four: Developing an Effective Response to Regulatory Inspections (FDA and EU)
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GMP Traiing in Tough Times - Getting it Right!
Developing and Deploying a Successful GMP Training Program
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FDA said a Johnson & Johnson company should have acted sooner to recall Tylenol and other products after receiving consumer complaints about moldy or mildew-like smells. The moldy smell was caused by trace amounts of a chemical that is sometimes applied to wood pallets used to store and transport Tylenol, Rolaids and other products.
FDA said the company first became aware of a problem in September 2008, but didn’t conduct a full investigation and report the problem to the agency until September 2009.
“When something smells bad literally or figuratively companies must aggressively investigate,” said Deborah Autor, the director of FDA’s Office of Compliance. She said the agency issued a warning letter to McNeil Consumer Healthcare, the J&J unit that makes over-the-counter Tylenol products, for violating agency reporting rules and the agency’s manufacturing practice rules. The warning letter wasn’t immediately available.
Read more and see the FDA-483 recently issued. Go to www.gmptrainingsystems.com/resources
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GMP Tip
Don’t let the FDA be your auditor!
Conduct internal audits and TAKE ACTION to address any gaps or shortcomings.
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Upcoming Boot Camps
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Feb 24 - 25 GMP Boot Camp - Fundamentals of GMP and QSR Irvine, CA
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How to Manage Regulatory Inspections - Part One: Getting Ready
Jan 22
How to Conduct Environmental Monitoring Effectively
Jan 29
How to Manage Regulatory Inspections - Part Two: The Inspection Room and the Control (War) Room
Feb 5
Fundamentals of Cleaning and Cleaning Validation
Feb 12
How to Manage Regulatory Inspections - Part Three: Staff Training and Preparation
Feb 19
Effectively Implementing CAPA (Corrective and Preventive Action)
Feb 26
How to Manage Regulatory Inspections - Part Four: Developing an Effective Response to Regulatory Inspections (FDA and EU)
Mar 5
GMP Training in Tough Times - Getting it Right!
Developing and Deploying a Successful GMP Training Program
Mar 12
Implementing cGMPs for Dietary Supplements
Mar 26
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U.S. Marshals, acting on the request from FDA, seized more than $1 million of food from a rodent-infested food processor and warehouse in Tennessee. Won Feng Trading Co., a Nashville distributor of bulk restaurant foods, had received a warning letter from the agency in May 2009, citing numerous deviations from good manufacturing practices.
In a follow-up inspection completed in November 2009, FDA investigators found evidence of widespread rodent infestation. They also observed “live and dead rodents, rodent hair, rodent nesting material, evidence of rodent-gnawed food and rodent urine,” as well as “insect filth and live birds in the building” and defects in the building that could allow pests to enter food storage areas.
This Warning Letter describes horrific conditions. Read the Warning Letter. Go to:
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GMP Tip
First - make GMP a Lifestyle in your company and avoid a Warning Letter. But if you receive a Warning Letter, prepare an effective response and DO WHAT YOU SAY YOU WILL DO.
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Upcoming Boot Camps - Register by Jan 15 and save 20%
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Feb 24 - 25 GMP Boot Camp - Fundamentals of GMP and QSR Irvine, CA
Mar 10 - 11 Validation Boot Camp Philadelphia, PA
Upcoming web seminars Cost effective & Convenient - in your office or conference room
www.gmptrainingsystems.com/web-seminars
How to Investigate Deviations and Failures Effectively
Jan 15
How to Manage Regulatory Inspections - Part One: Getting Ready
Jan 22
Developing and Deploying a Successful GMP Training Program
Jan 27
How to Conduct Environmental Monitoring Effectively
Jan 29
How to Manage Regulatory Inspections - Part Two: The Inspection Room and the Control (War) Room
Feb 5
Fundamentals of Cleaning and Cleaning Validation
Feb 12
How to Manage Regulatory Inspections - Part Three: Staff Training and Preparation
Feb 19
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We know budgets are tight. That’s why we are offering a 20% discount to attend our popular GMP Boot Camps in 2010. All we ask is that you register by January 15, 2010.
February 24 - 25 in Anaheim, CA
March 10 - 11 in Miami, FL (Special workshop conducted in Spanish)
April 28 - 29 in Newark, NJ
Validation Boot Camp
March 10 - 11 in Philadelphia, PA
See our entire 2010 schedule. Go to: www.gmptrainingsystems.com/public-workshops
Call us at 714-289-1233 to register and receive the discount.
GMP Tip
Plan your training early to ensure you get one of the seats in our popular GMP Boot Camps. Participation limited to 15 attendees to ensure optimal learning.
www.GMPTrainingSystems.com
Serving 1704 clients since 1996
Upcoming web seminars Cost effective & Convenient - in your office or conference room
www.gmptrainingsystems.com/web-seminars
Our holiday gift to you!
FREE web seminar - Making GMP a Lifestyle in your Company
Jan 8
How to Investigate Deviations and Failures Effectively
Jan 15
How to Manage Regulatory Inspections - Part One: Getting Ready
Jan 22
Developing and Deploying a Successful GMP Training Program
Jan 27
How to Conduct Environmental Monitoring Effectively
Jan 29
How to Manage Regulatory Inspections - Part Two: The Inspection Room and the Control (War) Room
Feb 5
Fundamentals of Cleaning and Cleaning Validation
Feb 12
How to Manage Regulatory Inspections - Part Three: Staff Training and Preparation
Feb 19
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We know budgets are tight. That’s why we are offering a 20% discount to attend our popular GMP Boot Camps in 2010. All we ask is that you register by January 13, 2010.
February 24 - 25 in Anaheim, CA
March 10 - 11 in Miami, FL (Special workshop conducted in Spanish)
April 28 - 29 in Newark, NJ
This offer also applies to our Validation Boot Camp.
March 10 - 11 in Philadelphia, PA
See our entire 2010 schedule. Go to: www.gmptrainingsystems.com/public-workshops
Call us at 714-289-1233 to register and receive the discount.
GMP Tip
Plan your training early to ensure you get one of the seats in our popular GMP Boot Camps. Participation limited to 15 attendees to ensure optimal learning.
www.GMPTrainingSystems.com
Serving 1703 clients since 1996
Upcoming web seminars Cost effective & Convenient - in your office or conference room
www.gmptrainingsystems.com/web-seminars
Our holiday gift to you!
FREE web seminar - Making GMP a Lifestyle in your Company
Jan 8
How to Investigate Deviations and Failures Effectively
Jan 15
How to Manage Regulatory Inspections - Part One: Getting Ready
Jan 22
How to Conduct Environmental Monitoring Effectively
Jan 29
How to Manage Regulatory Inspections - Part Two: The Inspection Room and the Control (War) Room
Feb 5
Fundamentals of Cleaning and Cleaning Validation
Feb 12
How to Manage Regulatory Inspections - Part Three: Staff Training and Preparation
Feb 19
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GMP Tip
FDA just published a guide to Food Safety Tips for Healthy Holidays. Download your copy. Go to:
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Our staff at GMP Training Systems, Inc. wishes you a joyous holiday season.
www.GMPTrainingSystems.com
Serving 1702 clients since 1996
Upcoming web seminars Cost effective & Convenient - in your office or conference room
www.gmptrainingsystems.com/web-seminars
Our holiday gift to you!
FREE web seminar - Making GMP a Lifestyle in Your Company
Jan 8
How to Investigate Deviations and Failures Effectively
Jan 15
How to Manage Regulatory Inspections - Part One: Getting Ready
Jan 22
How to Conduct Environmental Monitoring Effectively
Jan 29
How to Manage Regulatory Inspections - Part Two: The Inspection Room and the Control (War) Room
Feb 5
Fundamentals of Cleaning and Cleaning Validation
Feb 12
How to Manage Regulatory Inspections - Part Three: Staff Training and Preparation
Feb 19
Upcoming workshops
www.gmptrainingsystems.com/public-workshops
Validation Boot Camp
Feb 10-11, 2010 Philadelphia, PA
GMP Boot Camp
Feb 24 - 25, 2010 Anaheim/Newport Beach, CA
GMP Boot Camp
Apr 14 - 15, 2010 Newark, NJ
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We recognize that 2009 has been a tough year for everyone. To help usher in a more robust and prosperous year in 2010, we are pleased to offer you a FREE GMP web seminar.
David Markovitz, Founder of GMP Training Systems, Inc., is conducting a one-hour web seminar on Making GMP a Lifestyle in Your Company, and Not Just a Regulation. (We normally charge up to $597 to attend these types of programs.) THIS ONE IS OUR HOLIDAY GIFT TO YOU. (Click here for a description of this web seminar.)
When?
Friday, January 8
11:00 am to Noon EST
Where?
In your office or conference room.
Cost?
FREE - but we can only take the first 100 people who register. After that the price will be $197 to attend.
Can my entire group attend?
Yes, it will count as one order - just put us on a speaker phone and project the presentation on a screen.
How do I register?
Call us or register through our shopping cart. Don’t worry, the shopping cart price will be set at zero, and you won’t be required to input your credit card information.
GMP Tip
You can’t miss this value-packed FREE web seminar. David Markovitz will share his observations of over three decades in the FDA regulated industries on how to Make GMP a Lifestyle in your Company. Registration limited to the first 100 attendees. Register at www.gmptrainingsystems.com/GMP100108
www.GMPTrainingSystems.com
Serving 1701 clients since 1996
Upcoming web seminars Cost effective & Convenient - in your office or conference room
www.gmptrainingsystems.com/web-seminars
Our holiday gift to you!
FREE web seminar - Making GMP a Lifestyle in Your Company
Jan 8
How to Investigate Deviations and Failures Effectively
Jan 15
How to Manage Regulatory Inspections - Part One: Getting Ready
Jan 22
How to Conduct Environmental Monitoring Effectively
Jan 29
How to Manage Regulatory Inspections - Part Two: The Inspection Room and the Control (War) Room
Feb 5
Fundamentals of Cleaning and Cleaning Validation
Feb 12
How to Manage Regulatory Inspections - Part Three: Staff Training and Preparation
Feb 19
Upcoming workshops
www.gmptrainingsystems.com/public-workshops
Validation Boot Camp
Feb 10-11, 2010 Philadelphia, PA
GMP Boot Camp
Feb 24 - 25, 2010 Anaheim/Newport Beach, CA
GMP Boot Camp
Apr 14 - 15, 2010 Newark, NJ
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The holiday season brings happiness and joy to people. It also brings an increase in distractions at work. This increase in distractions leads to the increase of the probability of contamination, mix-ups and errors.
GMP Tip
During the month of December, it would be wise to schedule brief GMP reminder training sessions to help reduce the probability of things going wrong. Taking the time for prevention is ALWAYS better and less costly than fixing mistakes, reworking products, or even scrapping products.
www.GMPTrainingSystems.com
Serving 1700 clients since 1996
Upcoming web seminars Cost effective & Convenient - in your office or conference room
www.gmptrainingsystems.com/web-seminars
How to Investigate Deviations and Failures Effectively
Jan 15
How to Manage Regulatory Inspections - Part One: Getting Ready
Jan 22
How to Conduct Environmental Monitoring Effectively
Jan 29
How to Manage Regulatory Inspections - Part Two: The Inspection Room and the Control (War) Room
Feb 5
Fundamentals of Cleaning and Cleaning Validation
Feb 12
How to Manage Regulatory Inspections - Part Three: Staff Training and Preparation
Feb 19
Upcoming workshops
www.gmptrainingsystems.com/public-workshops
Validation Boot Camp
Feb 10-11, 2010 Philadelphia, PA
GMP Boot Camp
Feb 24 - 25, 2010 Anaheim/Newport Beach, CA
GMP Boot Camp
Apr 14 - 15, 2010 Newark, NJ
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