GMP Tips

FDA recently issued a draft of an updated Guidance Document for Process Validation: General Principles and Practices. The deadline for submitting comments to FDA is January 17, 2009. Get a copy of this draft guidance. Go to:

www.gmptrainingsystems.com/resources
Click on FDA Resources and scroll down.

www.GMPTrainingSystems.com
Serving 1532 clients since 1996

Upcoming web seminars
www.gmptrainingsystems.com/web-seminars

Jan 23, Feb 6, 13, 20
Effective GMP Auditing: Skills to Audit Manufacturing, Laboratories, and Suppliers

Upcoming workshops - 2009
www.gmptrainingsystems.com/public-workshops

GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

Cleaning Validation Boot Camp
March 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

We have appreciated your support throughout 2008.

Happy Holidays!

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1531 clients since 1996

Upcoming web seminars
www.gmptrainingsystems.com/web-seminars

Jan 23, Feb 6, 13, 20
Effective GMP Auditing: Skills to Audit Manufacturing, Laboratories, and Suppliers

Upcoming workshops - 2009
www.gmptrainingsystems.com/public-workshops

GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

Cleaning Validation Boot Camp
March 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

A nostrum is a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.

We’ve compiled a few graphics of nostrums from the early 1900’s. You may find them useful when preparing your GMP training materials.

To get your FREE copy of these graphics, go to
www.gmptrainingsystems.com/resources
Click on Timely Resource Articles and scroll down.
Note: These graphics have all been obtained from FDA’s web site.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1529 clients since 1996

Upcoming workshops - 2009
www.gmptrainingsystems.com/public-workshops

GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

Cleaning Validation Boot Camp
March 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

The new amendments to the Drug cGMP go into effect on Monday, December 8.

Get a copy of the Amendments. Go to www.gmptrainingsystems.com/resources
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1527 clients since 1996

Upcoming workshops - 2009

www.gmptrainingsystems.com/public-workshops

GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

The U.S. Government Accountability Office (GAO), the investigative arm of Congress, recently issued a report condemning FDA’s ability to monitor foreign drug manufacturers. The GAO said the FDA has faulty records on the facilities it oversees because it doesn’t require companies to update information such as corporate names and addresses annually. “FDA does not know the number of establishments subject to inspection,” the report says. Currently, domestic companies are inspected about every 2.7 years, but the rate for foreign inspections is roughly once every 13 years.

The report “confirms that the system deployed by FDA to police (foreign) facilities and keep Americans safe from poorly manufactured drugs is understaffed, overwhelmed and completely inadequate,” said Rep. Bart Stupak, D-Mich.

Read two news accounts and the GAO report. Go to:
www.gmptrainingsystems.com/resources
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1521 clients since 1996

Upcoming web seminars
www.gmptrainingsystems.com/web-seminars

Nov 25 Managing Your Staff in a Down Economy: How to Keep Your People Focused and Productive

Dec 8 Fundamentals of HPLC web course

Upcoming workshops - 2009
www.gmptrainingsystems.com/public-workshops

GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

Frustrated after twice asking Cincinnati-based Celsus Laboratories, Inc. to recall contaminated heparin, the FDA sent in U.S. marshals to seize 11 lots of the blood-thinning drug.

Read two articles with details here.
www.gmptrainingsystems.com/resources
Select Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1519 clients since 1996

Upcoming web seminars
www.gmptrainingsystems.com/web-seminars

Nov 14 New Revisions to Drug GMP: What You Must do to Comply

Nov 25 Managing Your Staff in a Down Economy: How to Keep Your People Focused and Productive

Upcoming workshops - 2009
www.gmptrainingsystems.com/public-workshops

GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

Yesterday we predicted the FDA would be strengthened under an Obama presidency. We’re already seeing evidence begin to surface. Here’s a headline from today, Nov 6. Obama Expected to Bolster FDA Oversight of Imports

Here’s an excerpt: The FDA, bedeviled by a salmonella outbreak and tainted medicine from China, is likely to monitor imports and fresh produce more closely under an Obama administration.

With President Bush no longer a roadblock, health officials also can expect new powers to control tobacco, from cigarettes to the recently introduced smokeless products called snus.

President-elect Obama, a former smoker struggling to avoid relapse, is a sponsor of legislation giving the FDA authority to control, but not ban, tobacco and nicotine.

Read the entire article. Go to:
www.gmptrainingsystems.com/resources

Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1515 clients since 1996

Upcoming workshops
www.gmptrainingsystems.com/public-workshops

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA Seats still available!

2009
GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

Now that the Democratic party will have control over Congress and the Presidency, can we expect a strengthened FDA?

The Democrats tend to favor more regulation. We predict that Congress will provide more funding for the FDA and that the new President will nominate a new Commissioner - one that will emphasize more frequent and stricter inspections.

Now is the time to prepare! Schedule internal audits! Schedule GMP training! Be proactive!

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1515 clients since 1996

Upcoming workshops
www.gmptrainingsystems.com/public-workshops

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA Seats still available!

2009
GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

With the grim economic news these days, we decided to do something special for our clients and readers. We have created a special audio seminar - Managing Your Career in a Down Economy: How to Save Your Job and Survive a Corporate Downsizing

The seminar is scheduled for November 6 at 8:00 pm EST and we made sure it is at an affordable price - only $29.95! A small investment to ensure the success of your career.

For a full description and to register, go to:
http://gmptrainingsystems.com/asp/gmp_store_081106.asp

This seminar will be conducted by David Markovitz, President of GMP Training Systems. David’s career spans over three decades. He started his corporate career during the Watergate turmoil when inflation ran rampant. He survived the recession in the early 1980’s and the stock market crash of 1987. He successfully grew his career while working for four major corporations before starting his own company in 1996. His business actually grew after the September 2001 attacks and market downturn and is thriving today.

And on November 25, David will conduct a seminar for Managers and Supervisors - Managing Your Staff in a Down Economy: How to Keep Your People Focused and Productive

For a full description and to register, go to:
http://gmptrainingsystems.com/asp/gmp_store_081125.asp

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1511 clients since 1996

Upcoming workshops
www.gmptrainingsystems.com/public-workshops

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA Seats still available!

2009
GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

David Markovitz, President of GMP Training Systems, Inc., here with a Thank You for the work you do. Here’s our story.

Two weeks ago my wife’s ear lobes got infected from a new pair of earrings. (Maybe they were manufactured in China.) She went to the Doc and got a prescription for an antibiotic. A few days later the infection spread to her left eye. An antibiotic eye drop was then prescribed. A few days after that the entire side of her face swelled up within hours. An emergency visit to her Doc got her admitted to the hospital where she spent two days and received antibiotics via IV line. (The last time she was hospitalized was 26 years ago when our daughter was born.) The antibiotics worked like magic and she was released on Oct 18 and looks about 95% back to normal today (Oct 20).

Yes, what we do is very personal. So thanks go out from our family to those who manufacture drug products and medical device products and follow GMP every day.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1507 clients since 1996

Effective Auditing Skills web seminar series starts Oct 22
A comprehensive course delivered “in your office” as eight one-hour web seminars.
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA Seats still available!

2009
GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.