Professional summary
Qualifications
Over thirty years experience in the pharmaceutical / medical device industry. Results-oriented individual with a track record of instituting and maintaining high levels of Quality Assurance, and leadership in the pharmaceutical, medical devices and biological industries. Expert in compliance, auditing, investigations, product complaint, validation, SOP development and assessment, PDMA, cGMP, CFR 21 related items, document control, State and Government regulations. 17 years Government Regulations, inspections, SOP Development. Individual has a minimum of 17 years industry experience in Quality Assurance, Quality Control, FDA Regulations, Regulatory Affairs. Individual has a minimum of 15 years of change control and document Read more
Qualifications
Over thirty years experience in the pharmaceutical / medical device industry. Results-oriented individual with a track record of instituting and maintaining high levels of Quality Assurance, and leadership in the pharmaceutical, medical devices and biological industries. Expert in compliance, auditing, investigations, product complaint, validation, SOP development and assessment, PDMA, cGMP, CFR 21 related items, document control, State and Government regulations. 17 years Government Regulations, inspections, SOP Development. Individual has a minimum of 17 years industry experience in Quality Assurance, Quality Control, FDA Regulations, Regulatory Affairs. Individual has a minimum of 15 years of change control and document approval experience and offers 10 years of non-conformance and 3 years of batch record review experience. Offers expertise in all industry related ISO regulations. Experience in European regulatory, Utilities/Facility and equipment validation, Medical devices.
Regulatory Expertise
Adverse Event Evaluation, Audits (both internal and external), GMP (Biological and Pharmaceutical) / ISO/Quality System Inspection Technique (QSIT)/ Quality System Regulation (QSR), Clinical – Bioanalytical / Labeling , Electronic Records & Electronic Signatures; 21 CFR Part 11, FDA, FDA - 483 and Warning Letter Responses/Consent Decree, certified auditor, lead auditor, Quality Assurance, Quality Control, Quality Management, Quality Systems Development/ Implementation, Regulatory Affairs, Regulatory Strategy Consulting, Protocol development and writing, Protocol deviations, Protocol amendment development and writing, query resolution, Reports - site visits, study reports, annual reports, review and interpret pertinent clinical data.
