Understanding and Performing Medical Device Internal and External Quality Audits- Part 1
$159.00 — $179.00
Most industry personnel are overwhelmed by national and international quality system regulations, standards, and guidance documents. Many believe if they obtain quality system certifications from a European Notified Body that they will automatically pass an FDA audit. However, this is not the case! FDA warning letter after Warning Letter prove otherwise…True that European quality management system standard (ISO 13485) and US quality system regulation (21 CFR Part 820) are very similar in nature; however, the philosophy, purpose, and scope of the FDA are totally different.
If top management do not plan for internal, supplier, and external audits, not only may regulatory compliance sanctions against the company occur, but the company may also lose its competitive advantage, have customer lawsuits, perform unnecessary recalls, and be known as a company with non-quality products and services.
This webinar series will provide valuable assistance to all medical device companies in preparing for internal, supplier, and external audits. The focus will be a basic understanding of quality system audits without confusing everyone with regulatory compliance jargon.
Part 1 includes the following:
- The definition, purpose and scope of audits
- Types of audits;
- How audits fit into a quality system
- How to prepare for/ act during external audits
- What to do after the external audit has been performed
Part 2 includes the following:
- FDA and EU medical device history, organization, laws, directives, regulations, standards, and guidance
- The similarities and differences between the FDA and the EU
- The similarities and differences between FDA inspections and investigations and Notified Body audit
- FDA’s Quality System Inspection Technique
Who should attend:
- Senior Management
- Quality Professionals
- Regulatory Professionals
- Document Control Specialists
- Record Retention Specialists
- Subject Matter Experts
- All personnel who want to learn about Audits
Get 20% off when you register both part1 and part2. Please contact email@example.com for the code.