FDA GMP, DEA, ISO Audits.

Regulatory & Quality Systems Consulting

·Regulatory Affairs Site Leader - worked closely with colleagues across a broad functional areas with responsibility for contributing to and; implementing regulatory strategies for the US, Europe, Canada, Asia Pacific and Japan in support of Class I, II, and III, IVD, ASR and GPR products multiple products in early development phases through registration and approval.· Lead FDA and other regulatory agency audits.· Driving and executing regulatory submissions including PMA’s, 510k’s, annual reports, renewals, supplemental applications, listings and registrations.· Interfacing directly with the FDA, EMEA, Health Canada, and other global regulatory agencies. · Lead in the coordination of product corrections, removals, and recalls, in compliance with regulations and standards.· Review and approval of promotional materials, labeling, website for all site product lines.· Provide Regulatory guidance to ensure compliance to 21CFR Section 820, IVDD, CMDR, and ISO 13485:2003.· Develop and/or review documents such as Standard Operating Procedures, protocols and reports, to ensure compliance with in-house and applicable regulatory and customer quality system requirements.· Establish, participate in, and in some cases lead the implementation of internal quality audits, and ensure that they are carried out on schedule.· Complies with, and ensures that all functional areas comply with the quality system requirements of Life Technologies and the applicable regulations and standards of the countries/markets in which Life Technologies designs, manufactures, and/or distributes product.

10/06-5/08MANAGER, REGULATORY AFFAIRS & CONSULTANTSafety Syringes, Inc., Carlsbad, CAResponsibility for contributing to & implementing regulatory strategies for the US and Europe in support of multiple products in early development phases through registration & approval.Establish, participate in, and in some cases lead the implementation of internal quality audits, and ensure that they are carried out on schedule.Assist in hosting audits from customers and regulatory agencies.Develop and/or review documents such as Standard Operating Procedures, protocols and reports.Track and monitor the Corrective Action and Preventive Action (CAPA) system to ensure that actions are appropriate, effective, and timelyAssist in the coordination of product corrections, removals, and recalls, in compliance with regulations and standards.

-Developed a risk-based strategy to design, monitor, analyze and trend compliance-related metrics associated with Amylin’s internal operations and GXP providers.-Working with QA Auditing, define and/or refine and harmonize Amylin’s root cause analysis for GXP audit findings and identify relevant CFR violations to assure consistency in application of standards by Amylin’s audit team.-Establish and implement a GXP-compliant audit frequency standard for Amylin’s internal and external audit programs.-Develop and maintain Quality Agreements and assist in overall vendor management and monitoring activities as necessary-Assist in supplying relevant information for the required sections of the Annual Report and APQR. -Overseeing generation and review of all GXP documents.-Initiating revisions to GXP Controlled Documents by preparing Document Change Requests including justifications.-Providing regulatory agency inspection support as necessary.

Global QA Services, Compliance Information:-Conduct systemic reviews of industry warning letters and Pfizer inspectional observations and issue reports on findings biannually to PGM Global Leadership.-Performed profiling of US FDA Investigators and other international regulatory authorities.-Managed the migration of legacy Pharmacia inspectional documentation into a centralized web based database-Compiled and issued US Area Inspection & Recall Summary Quarterly Reports.-Review new regulations, Competitor Warning Letters and 483s to provide an evaluation of business and quality impact. -Liaison with manufacturing facilities worldwide to ensure site compliance with Pfizer's Quality Standards. -Researched GMP "hot topics" and other Regulatory documents to aid in overall PGM Global Site Compliance. -Aided in the development of Inspectional Analysis Documents for PGM Site Leadership

-US Regulatory Affairs-Regulatory Intelligence Preceptorship Program-Develop, implement, and maintain a master schedule for internal and external cGMP QA Audit program-Coordinate and conduct cGMP audits of external vendors, suppliers, and contractors to ensure compliance to 21 CFR 210 & 211-cGMPs and quality standards-Coordinate and conduct special audits, as required (i.e., vendor qualification or “for cause” audits)-Coordinate and conduct cGMP audits of internal AZ Operations and Quality Assurance departments to ensure compliance to cGMPs and company standards -International Vendor Assurance Liaison- Provide QA support as an active voting member of the Strategic Buying Team-Keep Management apprised of quality and non-compliance issues, and expectations of regulatory agencies and cGMPs-Maintain knowledge of current FDA and European Regulatory Authorities trends, regulations, and guidances