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Quality Auditing, Enforcement Actions and FDA Medical Device Trends
This webinar will provide valuable assistance to all medical device companies in preparing for internal audits, supplier audits and external audits, how to behave during external audits and what to do after the external audits have concluded. The focus will be a basic understanding of quality system audits without confusing everyone with regulatory compliance jargon. The webinar will include the following:
- The definition, purpose and scope of audits
- The three types of audits
- How audits fit into a quality system
- FDA and EU medical device history, organization, laws, directives,regulations, standards and guidance
- The similarities and differences between the FDA and the EU
- How to prepare for external audits
- How to act during external audits
- What to do after the external audit has been performed
- The similarities and differences between FDA inspections, investigations and Notified Body audits
- FDA’s Quality System Inspection Technique
- Types of FDA and EU Enforcement Actions
- FDA medical device enforcement action trends
Overview of the webinar
This 90-minute webinar is a continuation of a medical device quality and regulatory compliance series:
- Part 1: Quality, Quality Systems and Regulatory Compliance
- Part 2: Regulatory Compliance: FDA and the EU
- Part 3: Quality Auditing, Enforcement Actions and FDA Medical Device Trends
- Part 4: Quality System Regulation
- Part 5: Document and Change Controls
- Part 6: Design Controls (Completed)
- Part 7: CAPA System (Completed)
- Part 8: Post-market Activities
- Part 9: Recent Trends in Regulatory Compliance
By attending this webinar, you will understand the three types of audits (internal audits, supplier audits and external audits) and how to prepare for them. You will also learn the purpose and scope of medical device audits, which guidance documents you will need, best audit practices, the similarities and differences between FDA inspections and investigations and Notified Body audits and what is expected when FDA, a Notified Body, or other external auditing body visits. Additionally, you will know the FDA and EU enforcement actions and FDA enforcement trends for medical devices.
Who should attend?
- Senior Management
- Regulatory Affairs
- Regulatory Compliance
- Quality Assurance Personnel
- Quality Engineers
- Manufacturing Engineers
- Design Engineers
Why should you attend?
Most industry personnel are overwhelmed by national and international quality system laws, directives, regulations, standards and guidance documents. As such, they believe if they obtain quality system certification from a European Notified Body that they will automatically pass an FDA audit. However, this is not the case, especially in the quality system areas of management controls, design controls, CAPA system and production and process controls. FDA's warning letters prove otherwise. It's true that Europe’s quality management system standard (ISO 13485) and U.S.A’s quality system regulation (21 CFR Part 820) are very similar in nature; however, your quality system is viewed totally different by the FDA than by the European Union. Not only is it required by law to perform effective quality audits, however the FDA requires you to also have a sound quality system with linkages to other medical device laws and regulations (such as pertaining to medical device registration and listing, market submissions, adverse events and corrections and removals); whereas the Notified Bodies do not.
If top management does not initiate an effective quality system, 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. Additionally, just because the FDA investigator is not allowed to address certain administrative violations (such as pertaining to registration and listing or market submissions) in FDA 483s (Objectionable Findings List), it does not mean that the compliance officer, who issues Warning Letters and other enforcement actions, will not address these findings.
Faculty - Mr.George Gary Calafactor
George Gary Calafactor is a 31-year food, cosmetic, drug, biologic, clinical, and medical device quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator and over 10 years of industrial experience as a biologic, pharmaceutical, and medical device industry quality assurance consultant, regulatory compliance specialist, and ASQ certified quality biomedical auditor. George’s expertise is primarily in medical device quality assurance and regulatory compliance, and has vast knowledge utilizing US, European, Canadian, Australian, Brazilian, Japanese, and Chinese medical device quality system and clinical laws, regulations, standards, and guidelines. George not only has inspected, investigated, and audited all types of US and foreign food, cosmetic, drug, biologic, medical device, and clinical facilities, but has also performed various food, pharmaceutical, biological, medical device, and combination product quality assurance and regulatory compliance operations, such as reconciling FDA Warning Letter and Consent Decree findings, monitoring and maintaining product and quality system failure investigations, non-conformances, complaints/ MDRs, and CAPAs, analyzing numerous quality system data, writing and revising numerous top and mid-level written procedures, training various governmental and industry personnel in the areas of medical device quality, quality system, design control, and documentation and change control, informing management and staff of current FDA and international enforcement policies, assisting start-up medical device/ combination product companies, and facilitating backroom operations during FDA inspections. George’s educational background includes 2 BS degrees in Chemistry and Metallurgical Engineering from the University of Notre Dame and an MBA in International Business from Indiana University. Currently, George is currently working toward a MS in regulatory affairs in pharmaceuticals, biologics, and medical devices (regulatory compliance concentration) from Northeastern University. As such, not only does George have vast internal working knowledge of medical device regulatory compliance and quality assurance operations, but he also understands the need to balance industry business goals against external regulations, the linkages between the various quality system and clinical subsystems, and the struggles with quality, cultural, and business barriers to achieve sound quality systems.