Summary With 42 years of experience in all aspects of Quality Assurance and Quality Control for the medical device, pharmaceuticals, and biotech industries, together we can significantly advance your company's Quality Culture. I've built quality systems for smaller to midsized firms and made substantial improvements to quality systems for larger firms. I've played a key quality role in the construction, validation, and regulatory approval of new manufacturing sites. I've been directly involved with regulatory audits by FDA, ISO, HBP (Canada), TGA (Australia), EMA (Europe) JFDA (Japan), Mexico, and ANVISA (Brazil). I've worked directly on Consent Decree remediation teams to update Quality Systems to current corporate regulatory standards, which were then formally verified by a third party (Quantic). With this direct knowledge of worldwide regulatory expectations and current expectations of Quality Systems, I can lead your Quality System to a 5 star level. Key Experience * ISO 9001 and 13485 * 510K Diagnostic test kits * NDAs Drugs * PMA Implantable Device * FMEA risk analysis * Design Control * Aseptic fill * Audits: FDA, EMEA, Health Canada, TGA (Autralia), PMDA (Japan), Anvisa (Brazil), and Corporate QA. * Trackwise deviation and change control electronic system * Phenix change control electronic system * SmartCAPA deviation electronic system * Plateau and MLC electronic training systems * Consent decree remediation * Lot release
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