The U.S. FDA said it plans on stepping up its prosecutions of pharmaceutical and food industry executives as part of its work to revamp the agency’s criminal division, said the Wall Street Journal.
According to the FDA, it has authority to “prosecute corporate executives for criminal actions” under a provision entitled “strict liability.” Although not enacted to a great extent in recent years, the FDA spokesman said that the government is not required to prove intent to defraud in order to convict.
Read more in a news account. Go to:
www.gmptrainingsystems.com/resources
Click on FDA Resources
GMP Tip
Avoid trouble with FDA by being up to date on FDA regulations and being GMP compliant. Effective GMP training can help avoid lots of problems. We have a web seminar set for Friday, March 12 on Developing and Deploying an Successful GMP Training Program. www.gmptrainingsystems.com/GMP100127
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Upcoming Boot Camps
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Apr 28 - 29 GMP Boot Camp - Fundamentals of GMP and QSR Newark,NJ
May 19 - 20 Cleaning Validation Boot Camp Philadelphia, PA
Upcoming web seminars Cost effective & Convenient - in your office or conference room
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GMP Training in Tough Times - Getting it Right!
Developing and Deploying a Successful GMP Training Program
Mar 12
Proven Steps to Reducing Waste in Process Validation
Mar 19
Defining Risk and Risk Levels: Implementing ICH Q9
April 9
Implementing cGMPs for Dietary Supplements
Apr 16
How to Implement FDA’s New Guidance on Process Validation
Apr 23
Validation Master Planning: Doing It Right!
May 14
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We know budgets are tight. That’s why we are offering a 15% discount to attend any of our popular GMP Boot Camps in 2010. Register by March 19, 2010 to save your company money.
April 28 - 29 in Newark, NJ
July 14 - 15 in Anaheim/Newport Beach, CA
This offer also applies to our Cleaning Validation Boot Camp.
May 19 - 20 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.
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FDA recently issued a Warning Letter to a Kellogg’s plant in Georgia for contamination associated with Eggo Buttermilk waffles. The plant had “significant deviations” from GMP and the company response had so far not addressed the violations.
Read a news account and the actual Warning Letter. Go to:
www.gmptrainingsystems.com/resources
Click on Timely Resource Articles.
GMP Tip
Cleaning and cleaning validation need to be taken very seriously, and not left to chance. We offer a two-day workshop, Cleaning Validation Boot Camp, where you can learn how to conduct cleaning properly. Learn more at www.gmptrainingsystems.com/public-workshops
www.GMPTrainingSystems.com
Serving 1733 clients since 1996
Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops
Apr 28 - 29 GMP Boot Camp - Fundamentals of GMP and QSR Newark,NJ
May 19 - 20 Cleaning Validation Boot Camp Philadelphia, PA
Upcoming web seminars Cost effective & Convenient - in your office or conference room
www.gmptrainingsystems.com/web-seminars
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
Ten Steps to Reducing Waste in Process Validation
Mar 19
Defining Risk and Risk Levels: Implementing ICH Q9
April 9
Implementing cGMPs for Dietary Supplements
Apr 16
How to Implement FDA’s New Guidance on Process Validation
Apr 23
Validation Master Planning: Doing It Right!
May 14
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In late January, U.S. Marshals seized 79 ozone generators from Applied Ozone Systems of Auburn, Calif.
The FDA has not determined that the seized products are safe and effective, and officials at Applied Ozone Systems never responded to a Dec. 21, 2009 FDA request for a voluntary recall of these ozone generators.
The FDA inspected Applied Ozone Systems in October 2009 after obtaining an inspection warrant when the owner of the company refused to allow agency staff to inspect the facility. The agency’s inspection revealed significant deviations from the FDA’s current good manufacturing practice (GMP) requirements for medical devices, and confirmed that the company has not obtained FDA marketing approval or clearance for these devices.
GMP Tip
It is ALWAYS a bad idea to deny FDA entry when they come to conduct an inspection. In this case, FDA got U.S. Marshals (guys with guns) to come in and seize their products. Read more. Go to: www.gmptrainingsystems.com/resources
Click on Timely Resource Articles.
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Serving 1729 clients since 1996
Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops
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
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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President Obama’s budget for FY 2011 is requesting $4.03 billion for FDA. This is a 23 percent increase over the current year, which was a 19 percent increase from 2009.
GMP Tip
In two years FDA’s budget soars 42 percent. You don’t have to be a rocket scientist to understand what this means for those of us regulated by FDA. Like the Boy Scouts always say - “Be prepared.”
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Serving 1727 clients since 1996
Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops
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 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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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
Click on Timely Resource Articles
GMP Tip
Be prepared for tougher FDA inspections. Conduct internal audits - and then correct any issues identified. Don’t let FDA be your auditor!
www.GMPTrainingSystems.com
Serving 1721 clients since 1996
Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops
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
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
Implementing cGMPs for Dietary Supplements
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
Click on Timely Resource Documents.
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Serving 1717 clients since 1996
Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops
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 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
www.GMPTrainingSystems.com
Serving 1714 clients since 1996
Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops
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
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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
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
Implementing cGMPs for Dietary Supplements
Mar 26
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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
Click on Timely Resource Articles.
GMP Tip
Don’t let the FDA be your auditor!
Conduct internal audits and TAKE ACTION to address any gaps or shortcomings.
www.GMPTrainingSystems.com
Serving 1710 clients since 1996
Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops
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 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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