Creating FDA-compliant cGMP Training Program

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, the FDA and other regulatory agencies have been increasingly 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, the FDA issued more than 40 Warning Letters that pulled up organizations for inadequate training of personnel.

Having an effective and compliant GMP training program is one of the most effective ways that can assure our customers, the regulators and legislators that we produce high quality services and drug products that are pure, safe and effective.

By attending this webinar, participants will gain a better understanding of the regulatory expectations for an effective and GMP-compliant training system. The instructor will draw upon more than twenty years of working in the pharmaceutical/biotechnology industry and a decade of developing and delivering effective GMP training programs to explain how such training programs should be implemented in a compliant manner.

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.
• 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
• QA/QC Personnel
• Manufacturing Managers/Supervisors
• Pharmaceutical and cGMP Auditors
• Compliance Officers
• Validation Specialists, Scientists, Engineers
• Medical/Technical Writers
• Consultants/Service Providers
• Engineering and Design Controls Teams
• General/Corporate Counsel

Instructor Profile:

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.

Topic Background:

The life sciences industries are under a growing scrutiny from the regulators, legislators, and our customers to produce high quality medical products and services. 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.

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