Webinar On Good Manufacturing Practices for Medical Devices

Description :

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

Operations

Consultants

Quality Unit managers and supervisors

Manufacturing

Training Managers and Directors

Documentation department