FALLS CHURCH, Va., Feb. 7, 2014 /PRNewswire-iReach/ — Beyond GMP Training:
Improving Human Performance and Reducing Errors
**Presented by FDAnews and LearningPlus**
March 19-20, 2014 – Bethesda, MD
http://www.fdanews.com/GMPTrainingWorkshop

While there are multiple references to training and performance within the FDA’s GMP regulations, the vagueness of the requirements may result in many questions for management, training professionals and employees.

The FDA wants industry to move beyond simple training — and continuous re-training that doesn’t add value. They want training to be part of a holistic system and process that contributes to performance and helps to assure that errors are reduced and quality is improved.

Take GMP training to the next level by focusing on 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.” What are some ways to make it easier for personnel to consistently perform — and succeed—in their jobs?

Getting an effective and consistent employee performance involves more than just training. Putting “knowledge in the world” can be far more effective than hoping that people simply have “knowledge in their heads.”

When producing pharmaceuticals or medical devices, manufacturers are producing not just a tangible product — they’re generating information about the process and product that contributes to understanding. Understanding how and why errors have occurred is a critical step in reducing error.

Human error isn’t a valid root cause. Rather, it’s a category of many different issues that need to be explored so an effective corrective action can be taken.

Presented by LearningPlus and FDAnews, Beyond GMP Training: Improving Human Performance and Reducing Errors is led by training expert James Vesper. This critical workshop thoroughly covers the best way to convey GMP knowledge to staff efficiently, accurately and effectively.

Through a series of hands-on exercises, attendees will develop and deliver a clear and concise GMP training program that will fully prepare employees to handle GMP with confidence. At this workshop, attendees 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

Register Today

Meet the Expert Instructor

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, and has had more than 30 years’ experience in the pharmaceutical industry, including 11 years at Eli Lilly. 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.

Conference Details
Beyond GMP Training:
Improving Human Performance and Reducing Errors
**Presented by FDAnews and LearningPlus**
March 19-20, 2014 – Bethesda, MD
http://www.fdanews.com/GMPTrainingWorkshop

Tuition: $1,797

Easy Ways to Register
Online: http://www.fdanews.com/GMPTrainingWorkshop
By phone: 888-838-5578 or 703-538-7600

About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

Media Contact: Michelle Butler, FDAnews, 703-538-7665, mbutler@fdanews.com

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SOURCE FDAnews