Reportedly Trained or Truly Trained: Developing GMP Training That Works


“Mr Vesper is the best presenter I have ever been in training with.”

Effective GMP training can save you millions of dollars — attend this highly interactive workshop and discover the best way to train your employees!

Despite dozens of 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.

During a recent 12-month period, the FDA issued more than 40 warning letters that cite inadequate training, and it could easily be part of the reason for hundreds more. With billions of dollars at stake for your company, you can’t afford to overlook the value of your GMP training program.

These days, it take more than a training session sign-in sheet to prove whether or not an employee is trained.

Attend this highly interactive one-and-a-half-day workshop and take the pain out of GMP training!

Presented by FDAnews and LearningPlus, Reportedly Trained or Truly Trained: Developing GMP Training That Works is led by training expert James Vesper. This critical workshop thoroughly explains 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 thoroughly prepare your employees to handle GMP with confidence.

At the Reportedly Trained or Truly Trained: Developing GMP Training That Works workshop you will:

  • Examine training systems and programs currently in use in the pharmaceutical, 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 program effectiveness

Click here to view the brochure.

Meet the Instructor
James Vesper
designs and develops instructional courses and workshops for pharmaceutical and medical device industries. He established and is president of the firm LearningPlus, Inc., and has had more than 24 years’ experience in the pharmaceutical industry.

Mr. Vesper worked eleven years at Eli Lilly and Co. His first assignment was as corporate industrial hygienist, followed by three years in Corporate Quality Assurance. He was responsible for issues concerning the manufacturing and testing of parenteral products made at Eli Lilly facilities and third parties worldwide. His last assignment was project leader of GMP Education and Instruction, establishing the department and its mission.

Since 1991, Mr. Vesper has been creating innovative instructional training products for the pharmaceutical and healthcare industries using video and computer technologies as more effective and efficient delivery media. Working as a consultant with a wide variety of clients, his firm creates integrated curricula for personnel and customized training courses targeted to specific needs. He presents papers and workshops at various international technical and professional meetings, including those of the International Society for Pharmaceutical Engineering (ISPE), GMP TEA, PDA, Pharmaceutical Sciences Group and PharmTech. In 2001, he was awarded the PDA’s Agallaco Award for Excellence in Training.

Nov. 17-18, 2008 • Raleigh, North Carolina

Marriott Raleigh Crabtree Valley
4500 Marriott Drive
Raleigh, NC 27612
Toll free (800) 228-9290
+1 (919) 781-7000
Room rate: $149 single or double (plus 12.75 percent tax)
Hotel reservation cutoff date: Oct. 26, 2008

Tuition is $1,897 and includes the workshop sessions, workshop written materials, two breakfasts, two luncheons and daily refreshments.

Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.

Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Cancellation Policy
In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Team Discounts
Significant tuition discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call +1 (703) 538-7600 for details.

Here’s What Your Colleagues Have to Say
“This was one of the best trainings that I have attended in my 8 years at [my firm]. It was very relevant to my job, and had a wealth of good examples and information. Jim is clearly an expert and he conveyed that knowledge very effectively.”

“Thanks again to you. The training was right on target and the questions were handled perfectly. Great job!”

“What I liked most was the number of real-world examples that Jim provided. This drove home many of the key points in the training, as well as kept the course interesting and engaging.”

“The training was great — I enjoyed it and learned a lot.”

“The trainer was excellent — very engaging.”

“What I liked most was his [Mr. Vesper’s] approach, summarizing general information, and the basis behind and the reinforcement through examples and case studies.”