Beyond GMP Training


Beyond GMP Training

Bethesda, MD • March 19-20, 2014

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.

Take your GMP training to the next level.

Beyond GMP Training:
From Training to Learning — Improving GMP Performance

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.”

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 “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, Beyond GMP Training: 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, 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 used 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, 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

Sign up now.

Here's What Your Colleagues Had to Say about the Course!

"It's obvious James has a lot of experience and knowledge on the subject. His approach makes it easy to respond and share information. Great job, James!"
    Christine Koenig, Manager, QA Compliance, Alcon Surgical
“I felt this course greatly motivated me to make changes in the way we train. I feel empowered with the tools necessary to move away from just training and towards comprehensive learning.”
    Nathan Lapham, Quality Control Manager, L. Perrigo Company

“A fantastic conference! The tools Jim taught will be incredibly valuable to my training department.”
    Ivan Odegard, GMP Training Specialist, Paddock Laboratories

“This is the best course I have attended. It gave me ideas that can help further my training points in my program.”
    Paula Thompson, QA Document Control Associate, Forest Pharmaceuticals, Inc.

“This workshop has inspired me to continue to be an advocate at my company to be a learning organization. Jim’s classroom style really fosters an open style of communication. I learned as much from my peers in the class as I did from my instructor.”
    Nancy Stefanick, Sr. Training Specialist, Stryker Instruments

“This two-day workshop has met/exceeded my expectations. All the topics/segments covered were something that I currently deal with or are having issues/struggles with. This is the first off-site workshop that I feel most of the participants received useful information that they can take back with them to their own organizations and apply.”
    Olive Yanilla, QC Master Trainer, L. Perrrigo Company

“I really enjoyed and feel that I learned a great deal from the instructor. Jim Vesper has an engaging quality, especially when describing real-life stories when reinforcing a training concept.”
    Monica MacInnis, Senior Quality Systems Trainer/Auditor, Fresenius Medical Care North America

“[James is] very enthusiastic and knowledgeable.”
    Robin Desmond, Quality Systems Manager, Micropen Technologies Corporation

“James was great! A lot of industry knowledge, great stories, very relevant information. Encouraged others to provide answers to questions versus ‘having all the answers.’ Knowledgeable on industry expectations.”
    Mary Johnson, Supervisor, Training and Development, APP Pharmaceuticals

“I enjoyed the entire workshop. It has given me reason to be excited about training again.”
    David DeSimone, Training Coordinator, Alexion Pharmaceuticals