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 Will Benefit:
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
Quality Unit managers and supervisors
Training Managers and Directors
Documentation department

Charles 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.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance