A printer friendly CV is available as a pdf file here.

A short biographical sketch for speaker introductions is available as a pdf file here.

Voice (510) 749-0450
fax (510) 749-0445
greg@fdaready.com

Outstanding auditor with expertise in FDA Compliance and Quality Assurance. Experienced in performing the most complex FDA inspections. Expert in FDA requirements. Excellent speaking and writing skills deliver accurate and systematic corrective action plans tailored to address FDA's greatest concerns about product quality.

  Experience

Investigator, US Food & Drug Administration, 1991-1998

• Conducted Pre-Approval and Regulatory Inspections of scores of pharmaceuticals, biologics, medical devices, specializing in biotechnology. Inspectional findings generally supported by FDA management, leading to numerous Warning Letters, recommendations to withhold approval, and further regulatory action. Inspections frequently tracked in the trade press.
• Co-founded landmark Pacific Regional Biotechnology Team, an innovative self-directed team with expertise in biotechnology methods and techniques. Unprecedented partnerships with industry recognized with Vice Presidential award and an FDA Award of Merit.
• Managed NDA Pre-Approval Inspection Program, Drug Quality Reporting System, and MedWatch for San Francisco District.
• Drafted inspectional guidance and compliance policy for ORA, CBER, and CDER.
• Trained other investigators in inspectional techniques in areas such as computer system validation, laboratory compliance, and biotechnology practices.
• Excelled in FDA training courses, including computer system validation, advanced biotechnology, law and evidence, investigative interviewing and interrogation, and sterility. (Complete list available on request.)

Director of Biotechnology, Quintiles Consulting, 1998-1999
Principal Consultant, FDAReady Consulting, 1999-present

• Performed systematic audits of pharmaceutical, biologic, and in vitro diagnostic production, specializing in biotechnology. Delivered detailed reports and corrective action plans from regulatory gap analyses.
• Improved clients' inspectional readiness with mock FDA audits.
• Structured and managed compliance improvement projects of small and intermediate complexity as Director of Biotechnology at a major consulting company.
• Trained clients in Quality and Compliance activities, including FDA Inspection Management, Failure Investigations, Laboratory Compliance, and Computer Validation.

  Skills

Compliance, Regulations, & Policy

Managed cases at FDA. Experienced in managing and reviewing responses to 483s as an FDA official and as a consultant. Currently maintaining database of FDA publications and announcements in real time. Developing knowledge base of FDA inspectional findings through FOI.

Auditing

Trained and skilled in techniques of evidence development and investigative interviewing. Continuously updating detailed audit outlines to assure that audits are systematic and efficient. Focus on root causes, not cosmetic or sporadic problems.

Speaking

Internationally-sought public speaker on many aspects of FDA compliance and Quality Assurance. Enthusiastic, knowledgeable, and interesting.

Writing

Well-organized and concise audit reports containing ranked findings, references to specific FDA expectations, and recommendations for correction. Examples of writing are available in the trade press and in technical books.

  Technical Areas of Expertise

Laboratory operations, method validation, aseptic processing, material management, facility design and flow, equipment and utility qualification, process development, process validation, cell culture, purification, synthetic chemistry, cleaning validation, and computer systems. Expertise in quality systems, including training programs, nonconformances and failure investigations, and programs for auditing internal operations and vendors.Extensive experience auditing all areas subject to FDA inspection.

  Education

M.S. Cellular & Developmental Biology,
University of Oregon, Eugene, Oregon, 1991

B.S. Cellular & Molecular Biology,
The University of Michigan, Ann Arbor, Michigan, 1986

  Recent Publications and Presentations

Publications

Member of the Advisory Board to Serentec Press Inc. of Raleigh, North Carolina, and Serentec Press Europe of Chichester, England

Quality at the Threshold of Enforcement: Perspectives from Industry and FDA. In Quality, R. Paincorp, Editor. [in press] Davis Horwood International Publishing.

The Quality Agreement: Compliance Considerations in Selecting a Contract Manufacturer, Biopharm, February 2001.

Biotechnology Manufacturing Issues: A Field Investigator's Perspective. In Biotechnology: Quality Assurance and Validation, K.E. Avis, C.M. Wagner, and V.L. Wu, Editors. 1999, Interpharm Press.

The Compliance Costs of Hasty Product Development, BioPharm, August 1999.

The History and Origin of Team Biologics, Regulatory Affairs Focus Volume 4, Issue 1, January 1999.

Speeches

Working with Contract Manufacturers. Featured meeting workshop, Barnett Conferences. March 2003, Boston, MA.

Planning for Success: PAIs and CMOs. Scaling Up from Bench to Clinic & Beyond, IBC Conferences. August 2002, San Diego, CA.

FDA Inspections of Drug Manufacturers. Invited Lecturer, University of California, Berkeley (BioEngineering 190), in partnership with ISPE. April 2002 and February 2003, Berkeley, CA.

Working with Contract Manufacturers. Dinner Meeting, American Society for Quality, San Francisco Chapter. May 2002, Oakland, CA.

The Costs of GMP Non-Compliance for Clinical Trial Materials (CTM). PARCS (Pacific Regional Clinical Supplies). October 2001, South San Francisco, CA.

Discussion Leader, CMOs and outsourcing companies. Roundtable Panel Discussions at Transitions from Bench To Clinic, IBC Conferences. August 2001, Boston, MA.

Quality Assurance and Facility Engineering: Resolving the Conflict. Dinner Meeting, ISPE-San Diego Chapter. April 2001, San Diego, CA.

Diagnosing Your Problems: What are the FDA Showstoppers? Dinner Meeting, American Society of Quality-San Francisco/Bay Area Chapter. March 2001, Oakland, CA.

Quality Assurance and Facility Engineering: Resolving the Conflict. Dinner Meeting, ISPE-San Francisco/Bay Area Chapter. December 2000, Berkeley, CA.

When Things Go Wrong: FDA Inspections of OOS, Deviations, and Corrective Action Programs. Workshop at Well Characterized Biologicals, IBC Conferences. September 2000, Washington, DC, and December 2000, San Diego, CA.

Compliance Considerations in Selecting a Contract Manufacturer. From Bench to Clinic, IBC Conferences. September 2000, San Francisco, CA

FDA Inspections of a Transferred Process. Production Site Transfer, IBC Conferences. September 2000, San Francisco, CA

FDA's "New" Expectations for Validation of Biologics. Validation of Biologics, Institute for International Research. May 2000, Seattle WA.

A Biotech Experience of preparing for and passing a PAI. Surviving and Passing FDA Inspections, Vision in Business. December 1999, London, England.

Conducting software validation and electronic data management in line with the FDA requirements. Surviving and Passing FDA Inspections, Vision in Business. December 1999, London, England.

A Successful FDA Site Inspection.Production Site Transfer, IBC Conferences. December 1999, London, England.

Regulatory Perspective on Facility Design and Engineering. ISPE Vendor Night, San Diego Chapter ISPE. November 1999, San Diego, CA.

Meeting FDA's Expectations for Compliance in Purification. Biotherapeutics '99, IBC Conferences. October 1999, Washington, DC.

Team Biologics: An Insider's Perspective. 11th Annual Technical Conference, Pharmaceutical Sciences Group. September 1999, Niagara-on-the-Lake, Ontario, Canada.

FDA's "New" Expectations for Validation of Biologics. Validation of Biologics, Institute for International Research. September 1999, San Francisco, CA.

Lessons from the Field: Regulatory Perspective on Process Validation. FDA Team Biologics Field Inspections, IBC Conferences. September 1999, Boston, MA.

Comparability and Validation. BioPharm Conference, BioPharm. June 1999, Burlingame, CA.

Process Development and Process Validation. West Coast Meeting, PDA. April 1999, San Francisco, CA.

Vendor Audits: A Regulatory Perspective. Chapter Meeting, ISPE San Diego Chapter. January 1999, San Diego, CA.