GMP Tips - caPA and Design Control - July 28, 2008

Recently three companies manufacturing medical devices received Warning Letters from the FDA. A large focus was on caPA (Corrective and Preventive Action) and Design Control.

One way to remain "current" with the GMP and QSR regulations is to read Warning Letters issued by FDA. Read these three Warning Letters.

Go to: www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1459 clients since 1996

New for 2008! Two new Survival Kits

• Survival Kit for Regulatory Inspections
• Validation Survival Kit
• Statistics Survival Kit coming soon
  

www.gmptrainingsystems.com/asp/survival_kits.asp

Upcoming workshops
Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA
Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA

Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

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

GMP Tips - The Last Lecture - July 28, 2008

This post is different than usual. Today we focus on an extraordinary professor at Carnegie-Mellon University. Last year this Professor of Computer Science, Randy Pausch, was diagnosed with pancreatic cancer. He died on July 25, 2008.

Carnegie Mellon has a tradition of asking speakers at their lecture series to address one age-old question: "What would you say if you knew you were going to die and had a chance to sum up everything that was most important to you?"

For Randy Pausch, this was not a hypothetical question. Married with three young children and in the midst of an astonishing career working with virtual reality, he had everything to lose. Yet his lecture is one of the most inspiring speeches you'll ever hear.

His remarkable speech has been captured and is among the most viewed videos on the internet. It is a powerful story of hope, grace, and optimism. Randy's words will definitely cause you to examine your life and career. To see it, go to www.thelastlecture.com

ABC will devote its program Primetime to Randy on Tuesday, July 29 at 10 pm EDT.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1459 clients since 1996

New for 2008! Two new Survival Kits

• Survival Kit for Regulatory Inspections
• Validation Survival Kit
• Statistics Survival Kit coming soon
  

www.gmptrainingsystems.com/asp/survival_kits.asp

Upcoming workshops
Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA
Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA

Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

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

GMP Tips - Mandela's Leadership Lessons - July 21, 2008

Last week marked Nelson Mandela's 90th birthday. Time ran an excellent story summarizing his Eight Lessons of Leadership. We found this to be worthy of adding to our Leadership library.

To read this article, go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Personal Productivity and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1457 clients since 1996

New for 2008! Two new Survival Kits

• Survival Kit for Regulatory Inspections
• Validation Survival Kit

www.gmptrainingsystems.com/asp/survival_kits.asp

Upcoming workshops
Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA
Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA

Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

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

GMP Tips - Keep Your GMP Awareness HIGH – July 15, 2008

One of the best ways we’ve seen companies keep GMP awareness high throughout their company is by posting pictures of their customers in prominent places. We’ve even seen billboard size posters of smiling customers hanging on the exterior of buildings.

Usually the picture is accompanied by a theme – one theme we saw that we particularly liked was “Our Measure of Success.” Ah, our Measure of Success is that our customers are still alive and enjoying a good quality of life thanks to the work we do.

Hallways, training rooms, conference rooms, lunch rooms and cafeterias are good places to put these. Make sure they are located where employees enter the building. A daily reminder of how important our customers are goes a long way in instilling pride in our workers. And when people have a sense of pride in their work, they tend to be more careful and vigilant.

We recently conducted training for a company that manufactures drugs for animals. They have photos of their employees with their pets in the hallways throughout the facility. Those who work there are customers of their own products. And people get a thrill of seeing their own photo hanging in the plant. These beat generic “Do it Right!” posters any day of the week.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1453 clients since 1996

New for 2008! Two new Survival Kits
Survival Kit for Regulatory Inspections
Validation Survival Kit
www.gmptrainingsystems.com/asp/survival_kits.asp

Upcoming workshops
Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA
Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA
Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

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

GMP Tips - GMP (FDA) and Safety (OSHA) - July 7, 2008

In the US, every company is mandated by OSHA to conduct safety meetings on a regular basis. The focus of these meetings is on the safety of those working at the company.

GMP can also be viewed as a safety program - ensuring the safety of our customers.

GMP Training Tip
When you conduct a Safety Meeting, reserve an additional fifteen minutes or so at the end to conduct a GMP training session. Your people are already gathered together and focusing on safety. Shift the conversation to the safety of your customers and, voila, you are now in a GMP meeting. Document this training and you can fulfill FDA's requirement of conducting GMP training on an ongoing basis and with sufficient frequency to assure employees remain familiar with cGMP requirements.

Our GMP Training System is an ideal product for this purpose. Each of the twelve modules is designed to take about fifteen minutes to deliver. For more info, go to:
www.gmptrainingsystems.com/asp/gmp_training_system.asp

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1449 clients since 1996

Upcoming workshops
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

New for 2008! Two new Survival Kits
Survival Kit for Regulatory Inspections
Validation Survival Kit
www.gmptrainingsystems.com/asp/survival_kits.asp

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