Presented by George Gary Calafactor, EAS Independent Consultant
Medical Device manufacturers understand the tight FDA regulations and legal obligations surrounding devices. From initial safety and effectiveness study design through Pre-Market Applications (PMAs), Pre-Market Notifications (PMN), registration, Good Manufacturing Practices (GMPs) through reporting of adverse events, every detail must be attended to in a thorough and documented quality system. Quality systems are key indicators of a company’s commitment to producing a safe and effective product as well as a company’s good record-keeping practices as records are tested and maintained to provide transparency to FDA inspectors in the case of an audit.
The more robust the quality system the better outcome companies can expect when FDA knocks at the door for both routine audits and those which are prompted by quality questions or concerns.
Good Quality Systems are verified in a variety of ways – through in-house audits; audits with the assistance of third-party consultants who specialize in quality systems; and officially by FDA inspectors. Many companies use a combination of “mock” and “desk” audits to enhance their systems, identify gaps and initiate improved procedures where necessary.
The time to assess compliance gaps is now as a product’s quality is the basis for good business practices, ensuring the safety of customers, verifying that the product works effectively and in a manner consistent with which it was approved by FDA. Quality system audits are even used in due diligence assessments in advance of mergers and acquisitions.
Join EAS Independent Consultant, George Gary Calafactor for this EAS on-demand webinar, including detailed coverage of Medical Device Quality Auditing.
- Learn about the types and purposes of audits
- How FDA and EU audits differ in scope
- How quality systems link to other systems within the business practices such as
- Accounting and Finance
- Customer Service
- Marketing and Sales
- Informational Technology
- FDA’s enforcement requirements of quality systems (Compliance Against External Requirements and Governmental Regulations)
- Quality Assurance (Internal Goals, Objectives, and Requirements; Continuous Improvement)
- Quality Control (Testing and Evaluation Against Standards)
- How FDA enforces regulations and gaps found during audits
- Trends found in FDA enforcement for medical devices in recent years
About the Presenter
George Gary Calafactor
George Calafactor is an EAS Independent Consultant on matters pertaining to domestic and international medical device and combination product quality assurance and regulatory compliance issues. Mr. Calafactor offers a diverse background in quality and regulatory consulting, auditing, manufacturing, and pharmaceutical, biologic, medical device, and combination product operations, with vast experience in the medical device and combination product industries, internal FDA operations, and the international business arena. He performs reconciliation and FDA readiness activities associated with FDA levels I, II, and III QSIT medical device inspections and revises and creates quality system procedures using FDA and international laws, regulations, standards, and guidance documents. He also assists in various FDA inspection front-room and back-room activities including company liaison representation and subject matter expert coaching.