Building a Compliant Documentation and Training System

This 60 minutes webinar will give a better understanding of the relationship between compliance, documentation, and training. It will provide participants with the ability to effectively meet regulatory requirements, properly integrate training into their quality system, and develop effective compliance documentation that meets both regulatory and training purposes.

There is an increasing trend for regulatory agencies to view compliance documentation and training with increased scrutiny. Documentation and training that is improperly developed, implemented, and/or recorded presents a significant regulatory risk for manufacturers. In addition to meeting regulatory requirements, documentation and training, that is properly developed, also can serve as the basis for a well-controlled operation and a highly-competent workforce.

Areas Covered in the Session : 

• Global regulatory requirements for compliance documentation and training
• The relationship between compliance documentation and training
• Read and understand versus demonstrated competence
• Regulatory requirements
• Elements of a compliant documentation and training system
• How to conduct a compliance documentation and training analysis
• Compliance documentation and training as the basis for world-class operational control and performance improvement

Who Should Attend:

A must attend webinar for all personnel / companies in the Pharmaceuticals, Medical Devices, Biotechnology, Cosmetics, Personal Products, Foods & Beverages fields. The professionals who will benefit include all:

• Training Managers and Directors
• Regulatory Affairs
• Quality Professionals
• Documentation department
• Compliance officer
• Product Development Professionals
• QA/QC analysts
• Internal Auditors
• Quality Assurance scientists
• Production
• Operations
• Consultants
• Quality Unit managers and supervisors

Course Director: CHARLES H. PAUL

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.