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  • Product id  :  IQW15C8384

    Recent Trends in Regulatory Compliance

: George Gary Calafactor
: Friday, January 20, 2017 | 10:00 AM PST | 01:00 PM EST
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: 90 Mins
: Basic & Intermediate
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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
Not only will this webinar examine recent trends in medical device regulatory compliance but also give real-world examples of non-conforming medical device companies.
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 have quality system procedures and records, 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. By understanding medical device regulatory compliance trends, you can prevent or minimize FDA enforcement actions. 
  • Recent Trends and Developments in Medical Device Regulatory Compliance
  • Example post-market assessment activities
  • Experience of FDA staff vs. industry staff
  • Product lifecycle management and regulatory compliance strategy
  • Changing technology
  • Maintaining and Establishing a proper risk-based quality system
  • Product Defects
  • Product Safety and effectiveness
  • Balance of speed to market vs. regulatory compliance
  • Best practices
  • Off-label usage
  • Top FDA Warning Letter Medical Device Deviations and recommended corrections
  • Bring your own devices (BYOD)
  • Understanding of medical device tort law and cases
  • FDA CDRH strategic priorities
  • Importance of Medical Device Regulatory Compliance
  • Example Case Study: Sulzer Orthopedics
  • Senior Management
  • Regulatory Affairs 
  • Regulatory Compliance
  • Quality Assurance Personnel
  • Quality Engineers
  • Manufacturing Engineers
  • Design Engineers

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.

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