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 to be Covered:
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
Who will Benefit:
Product Development Professionals
Research & Development
Quality Assurance scientists
Quality Unit managers and supervisors
Training Managers and Directors