GMP Training Practices to ensure Regulatory Compliance

Why Should You Attend:

The life sciences industries are under a growing scrutiny from the regulators, legislators, and our customers to produce high quality medical products and services. For the past decade more and more, the FDA and other regulatory agencies have been focusing their efforts on ensuring that the people who produce medicines and other medical products and services are qualified. The lack of or inadequate training continues to dominate the FDA's inspectional observations. In a recent 12-month period, there was an excess of 40 warning letters issued by the FDA that stated inadequate training.

Having qualified staff should not be seen only as a regulatory requirement. An effective and compliant GMP training program also provides a competitive advantage for our businesses. This is especially true in these difficult economic times. The cost cutting measures that organizations implement often result in the reduction of qualified staff, which leads to situations where the people who are left have to pick up tasks that their colleagues used to do. Moreover, budgetary pressures cause companies to reduce their training programs. The combination of these two factors often leads to additional stress and an increase of mix-ups, errors and contamination. Having an effective and compliant GMP Training Program is one of the most effective ways that we can assure our customers, the regulators and legislators that we produce high quality services and drug products that are pure, safe and effective.

Areas Covered in the Webinar:

• The need for an effective GMP Training Program in your organization.
• Regulatory requirements and expectations for a well-trained workforce.
• The implementation of an effective and FDA-compliant GMP Training Program.
• Training is a Quality System.
• Delivering a memorable GMP Training.
• Follow-up efforts that ensure the reinforcement of GMP Training.

Who Will Benefit:

• Training Department Management
• Training Professionals
• Instructional Designers
• Supervisory Management of Operational departments

Henry Urbach
Principal, GMP TDC LLC

Henry Urbach, is the founder of GMP Training, Development and Consulting, GMP TDC LLC, a New York-based consulting organization serving Life Sciences industries. He has 20+ years of Life Sciences experience having held positions of increased responsibility in GMP Training and QC Microbiology. His experience includes managing and implementing CGMP compliance and quality systems training, for major pharmaceutical and biotechnology organizations. He is a dynamic speaker specializing in FDA and ICH compliance. He is a Certified Quality Auditor. His technical education is further complemented by his BA degree in Biology and MBA, which provide a scientific and business insight. He is a member of the ASTD, ASQ, and GMP TEA, a national organization of Life Sciences training professionals.

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