Crawford confirmed by Senate - FDA Commissioner

Dr. Lester Crawford was confirmed by the United States Senate on July 18, 2005 to become the FDA Commissioner. He has been Acting Commissioner since early 2004 and was nominated by President Bush in February 2005.

Learn more about Dr. Crawford at http://www.fda.gov/oc/crawford/default.htm

Scroll down and read our posting of July 8, 2005 to gain some insights into Dr. Crawford's thinking about the future of FDA.

Our audio seminar on July 26 was a great success. We had several hundred attendees. Common Problems with Gradient Elution Liquid Chromatography: Proven Solutions and Prevention Strategies with Dr. John Dolan.

You can purchase an audio CD of this seminar. You will also receive a written transcript of this one-hour program. Click here for more information and to order http://www.gmptrainingsystems.com/asp/lcgc_store.asp

Great Training Example for You

We’ve often found that reading the newspaper regularly is an excellent way to find examples to use in GMP training sessions. Here’s an article from USA Today, dated July 12, 2005, that you should find useful. It’s about a company called Able Laboratories Inc. We’re certainly going to use this as an example in our GMP training workshops.

Go to http://www.gmptrainingsystems.com/asp/articles.asp to get a copy of the article.

Learning from other's experiences is a true and tried method of learning. We have always used FDA-483s and FDA Warning Letters in our GMP workshops. Many of these can be easily found on FDA’s web site – www.FDA.gov.

On July 6, 2005, Able Laboratories received a fifteen page 483 containing twelve major observations. This follows a May 25, 2005 letter Able Labs sent to their customers launching a recall of ALL products under the Able Laboratories Inc. label.

During our GMP trainings, we’ve stressed over and over and over the importance of following the current Standard Operating Procedures. Here’s an example of what can go wrong when people don’t follow procedures.

You can get a copy of the Able Labs 483 here – http://www.gmptrainingsystems.com/asp/articles.asp

Stay tuned for further developments in this situation.

We design and conduct GMP training programs for the Pharmaceutical and Medical Device industries. Our clients include Pfizer, Bristol-Myers Squibb, Baxa Corp., Genentech, Wyeth, GlaxoSmithkline, Merck, Baxter Healthcare, Grifols Biologicals, and several others.

Learn more about our services at www.GMPTrainingSystems.com

FDA Commissioner Speaks Out on Innovation

For the first time in recent history, an FDA insider has been nominated to become FDA Commissioner. Lester M. Crawford, D.V.M., Ph.D., the current Acting FDA Commissioner has been nominated by President Bush to become the next FDA Commissioner. Following are selected excerpts from his testimony before Congress during his confirmation hearing.

“My vision for the future of FDA is one of transformation. Internally at FDA, we’re transforming from domestic-focused, paper-based processes, employing yesterday’s technologies, to global, electronic-data driven decisions that apply the latest science. And we’re transforming our culture to one of transparency, collaboration, and cutting-edge thinking."

“By adopting a quality systems approach in all of our operations, we will increase productivity and promote better health outcomes.”

“As we confront 21st century challenges, 21st century solutions are key; that is why “innovation” will be at the center of everything FDA does in the time ahead.”

What can we learn from Dr. Crawford’s words?

1. He intends to lead the FDA in a transformation process. This means change. Big change.
2. He plans to adopt a quality systems approach to achieve this transformation.
3. Innovation will be at the center of everything FDA does.

What does that mean for FDA regulated industries?

It means that FDA will expect us to also adopt quality systems approaches. Several of FDA’s key initiatives and guidelines over the past two years point right to taking a quality systems approach.

It means FDA will expect us to use innovation as a key driver in our businesses as well - innovation of products as well as innovation of processes.

In fact, FDA recently released a report titled “Innovation or Stagnation.” You can download and read this report at http://www.gmptrainingsystems.com/asp/articles.asp

You can wait for FDA to “force” you to adopt a quality systems approach and begin innovating your processes. Or you can take the initiative and get moving. Stay ahead of FDA. It will save you time, money, and headaches.

You can increase your personal and your organization’s Innovation Instinct.

Innovation Instinct is the ability to generate valuable ideas, build on them, and most importantly, implement them.

Go to www.InnovationBootCamp.com

to learn how we can help you stay ahead of the FDA.

Proper Preparation for Effective GMP Training

Step One - Establishing Objectives and Expected Outcomes

The first step in establishing an effective GMP training session is to establish the objectives and expected outcomes of the training session. This does not have to be difficult. Here's a formula we've used for over twenty years.

Identify the "Must Knows." The "Must Knows" describes information or knowledge the participant must know in order to perfrom their jobs effectively.

Identify the "Must Dos." The "Must Dos" describe how the knowledge is to be applied on a daily or task-by-task basis in order to do their jobs effectively.

Learn more at http://www.gmptrainingsystems.com/asp/articles.asp
Here you can read the rest of this article written by David Markovitz, President of GMP Training Systems.

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