From Training to Learning Improving GMP Performance
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.
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 “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, 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 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
- Compliance officers
- Consultants/service providers
- Engineering and design controls teams
- Executive management
- General/corporate counsel
- Manufacturing directors and supervisors
- Medical/technical writers
- Pharmaceutical and cGMP auditors
- QA/QC personnel
- R&D staff
- Regulatory/legislative affairs professionals
- Risk management specialists
- Training personnel
- Validation specialists, scientists, engineers
James Vesper designs and develops instructional courses and workshops for the pharmaceutical and medical device industries. He is founder and president of the firm LearningPlus, Inc., and has had more than 30 years' experience in the pharmaceutical industry. Mr. Vesper worked 11 years at Eli Lilly. 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, GMP TEA, PDA, Pharmaceutical Sciences Group and PharmTech. 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.
Feb. 25-26, 2013
Embassy Suites Raleigh-Durham Airport/Brier Creek
8001 Arco Corporate Drive
Raleigh, NC 27617
Toll Free: (800) 362-2779
+1 (919) 572-2200
Room rate: $159 plus 12.75 percent tax
Reservation cut-off date: Feb. 4, 2013
Aug. 19-20, 2013
Sheraton Philadelphia University City Hotel
3549 Chestnut Street
Philadelphia, PA 19104
Toll Free: (888) 627-7071
+1 (215) 387-8000
Room rate: $179 plus 15.2 percent tax
Reservation cut-off date: July 29, 2013
Tuition is $1,897 and includes the workshop sessions, workshop written materials, two breakfasts, two luncheons and daily refreshments.
Send Your Team for Maximum Benefit
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600