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Creating FDA-compliant cGMP Training Program

  • Training

  • 60 Minutes
  • Compliance Online
  • ID: 5974560
This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.

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

Course Provider

  • Henry Urbach
  • Henry Urbach,