Compliance Trainings, Online
2016-03-21
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
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