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Quality Insider

From Training to Learning: Improving GMP Performance

Interactive workshop reveals most efficient way to convey GMP knowledge to staff

Published: Thursday, October 6, 2011 - 08:51

(FDAnews: Falls Church, VA) -- FDAnews and LearningPlus are presenting an interactive workshop, From Training to Learning: Improving GMP Performance, to be held Oct. 26–27, 2011 in Raleigh, North Carolina.

Click here to register and for further details.

 Although there are more than 20 references to training within the Food and Drug Administration's (FDA) Good Manufacturing Practice (GMP) regulations, the vagueness of the requirements is a constant source of confusion for companies, their training officers, and their employees.

21 CFR 211.25 states: “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.”

While this appears clear, companies continually fall short in their employee training. Recently, the FDA has issued more than 40 warning letters citing inadequate employee GMP training.

Meanwhile, companies consistently claim their employees are trained, and can prove it by presenting stacks of sign-in sheets from training sessions. This is the training hoax: Operators are told in just a few hours about the contents of hundreds of pages of standard operating procedures (SOPs).

As a result, these reportedly trained professionals can’t possibly have learned the material, and have little recollection of procedures or knowledge of how to handle deviations, which results in defects, recalls, and other product problems that cost companies untold billions of dollars.

Unfortunately, GMP trainers are often expected to do just that—create a training course, get everyone’s signature on the “happy sheet,” and go away. For training to be truly effective, organizations must move from a training environment to a learning environment.

Presented by LearningPlus and FDAnews, From Training to Learning: Improving GMP Performance is led by training expert James Vesper. This critical workshop thoroughly covers the best way to convey your GMP knowledge to your staff efficiently, accurately and effectively.

Through a series of hands-on exercises, attendees will develop and deliver a clear and concise GMP training program that will fully prepare their employees to handle GMP with confidence. At this workshop,attendees  will:
• Examine training systems and programs at use in the pharma, medical device, and other industries
• Identify current expectations that regulatory agencies and quality auditors have of training systems and programs
• Use a systematic approach to decide when training is—and isn’t—a useful solution to deviations and problems
• Examine models that are used to efficiently design and produce training solutions that meet specific goals
• Design a training solution that would be suitable for ongoing or reinforcement training of operations, staff, technical and management personnel
• Discover how the way procedures are written can help—or hurt—training efforts
• Discuss five ways to assess individuals and evaluate training effectiveness

Instructor James Vesper designs and develops instructional courses and workshops for the pharmaceutical and medical device industries. He is founder and president of LearningPlus Inc. and has had more than 28 years’ experience in the pharmaceutical industry. Vesper worked 11 years at Eli Lilly, and since 1991, he has been creating innovative instructional training products for the pharmaceutical and health care industries. In 2001, he was awarded the PDA’s Agalloco Award for Excellence in Training. He is also an advisor to the World Health Organization’s Global Learning. Opportunities/Vaccine Quality Group and has mentored, designed and developed learning programs that are in use worldwide.

Click here to register.


About The Author

FDAnews’s picture


FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the U.S. Food and Drug Administration (FDA). Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books, special reports, and conferences to stay in compliance with international standards and FDA’s complex and ever-changing regulations to get their products to market faster and boost profits.