From Training to Learning

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While there are more than 20 references to training within the FDA’s GMP regulations, the vagueness of the requirements is a constant source of confusion for companies, their training officers and their employees.

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Regulation 21 CFR 211.25 clearly 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 an increasing number of warning letters citing inadequate employee GMP training.

Meanwhile, companies consistently claim their employees are trained and they 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 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, resulting 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 training sign-in sheet and hope that people will work differently. For training to be truly effective, organizations must move from a training environment to a learning environment.

Presented by James Vesper of Valsouce Learning Solutions and FDAnews, From Training to Learning: Improving GMP Performance is led by training expert James Vesper, PhD, MPH. 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, you'll develop and deliver a clear and concise GMP training program that will fully prepare your employees to handle GMP with confidence. At this workshop, you 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 personnel training 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, technical and management personnel

  • Discover how the way procedures are written can help — or hurt — training efforts

  • Discuss 5 ways to assess individuals and evaluate training effectiveness