Good Manufacturing Practices for Medical Devices

This training concerning Good Manufacturing Practices is a requirement for all staff involved in the manufacturer of medical devices. Regulations are complicated, and today more than ever before, because of global regulatory requirements, companies must be familiar with and comply with the regulations governing the products they make, for each country in which they sell.

This Webinar will address the specific requirements of FDA CFR Part 820 and ISO 13485 with some further emphasis upon design controls and compliance/enforcement.

Areas Covered in the Session : 

• Medical Devices Defined
• Classifications of Medical Devices
• Governing Regulations FDA CFR Part 820 – Review of Subparts A through O
• Relationship of FDA CFR Part 820 to ISO 13485
• Importance of Design Controls
• Compliance and Enforcement
• Combination Products

Who Should Attend:

A must attend webinar for all personnel / companies in the Medical Devices industry. The professionals who will benefit include all:

• Regulatory Affairs
• Quality Professionals
• Product Development Professionals
• Production Department
• QA/QC analysts
• Research & Development
• Quality Control
• Quality Assurance scientists
• Quality Auditors
• Internal Auditors
• Operations
• Consultants
• Quality Unit managers and supervisors
• Manufacturing
• Training Managers and Directors
• Documentation department

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.