Last year it had to reject 14 lots of product due to contamination. So the company retrained its employees on aseptic technique and figured, problem solved. You can imagine Gibson's reaction when it was forced to reject 13 more contaminated lots this year.
These details come from a warning letter issued to Gibson. But they could easily apply to many drug, biologic, device or diagnostics firms. They could apply to you.
The risks go beyond warning letters. Regulated manufacturers face multi-million-dollar lawsuits for injury or death, plus huge costs to destroy the contaminated products.
And it often happens because, despite being trained, employees don't really understand what they've been taught.
Isn't it time to do some learning of your own — on how to change your training methods to improve GMP compliance and avoid unhappy situations like Gibson's?
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 From Training to Learning: Improving GMP Performance, you will:
Here's what previous attendees have to say:
"I really enjoyed this course, the engaging activities. Hearing the real world experiences helped to
bring the workshop examples to life. There are many examples that I can use on the job. Jim is a very good speaker. He is engaging and encourages participation."
Procedures & Training Specialist, Daiichi Sankyo
"I liked the engagement and energy of Jim as presenter. Great examples of training goof ups. Jim is a great presenter with an excellent knowledge
Vice President Risk Management, Baxter Healthcare
"Training was very well done and contained a lot of knowledge I can bring back to my job function. Jim is very knowledgeable and enjoyable as a
trainer. He has a lot of knowledge and experience to draw upon. Very helpful with providing ideas and resources."
Senior Specialist, Schering Plough
"I liked learning the theory behind training program design. Jim is a great speaker
— engages the audience. Thoroughly knows his material."
Senior Director Regulatory Affairs, Aveva Drug Delivery Systems
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 28 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.
April 8–9, 2010
Omni Chicago Hotel
676 North Michigan Avenue
Chicago, IL 60611
+1 (312) 944-6664
Room rate: $189.00 single (plus 15.4% tax)
Reservation cutoff date: 3/17/10
Register Early — Space is LimitedHurry — register early because space is limited! Your tuition of $1,897 per attendee includes the two-day workshop, all conference materials, continental breakfast and lunch each day.
Send Your Team for Maximum Benefit
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.
Cancellations and Substitutions
Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund less a $200 administration fee. No cancellations will be accepted nor refunds issued within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. 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.
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