Regulatory, FDA, Expert Witness and Pharmaceutical Chemist

Expertise

Regulatory

• Food and Drug Administration compliance.
• Prepare submissions to the Food and Drug Administration.
• Quality audits and implementation of changes.
• Simulated FDA inspection - quality and readiness audits.
• Establish and review quality assurance procedures for GMP and GLP.
• Develop and write appropriate Standard Operating Procedures (SOPs).
• Assist firms with Consent Decrees, Warning Letters, and 483s.
• Chemistry, Manufacturing, and Controls (CMC) expert.

Technical

• Laboratory procedures and documentation.
• Pharmaceutical package and labeling and product compatibility.
• Selection and testing of rubber stoppers and components.
• Lyophilization.

Management

• Laboratory management.
• Work flow design.
• Strategic planning

Expert Witness and Subject Matter Expert

• Assist attorneys in drug and medical device cases.

Experience

Independent Consultant, 1996- Present

FDA, Philadelphia District FDA, 1989- 1996

Director of Science Branch, 1992 - 1996

• Direct through intermediate managers, a laboratory staff of 30 persons whose activities involve methods validation of New Drug Applications (NDA's) and Abbreviated New Drug Applications (ANDA's), drug product surveys and Research Projects.
• Interface with my counterparts in the Investigation and Compliance branches, and with Headquarters in Rockville, Maryland.
• Improved Lab's "Time Frame" percentage from 68 to 90%, a figure considered to be excellent. The Lab moved from 17th place out of 18 Labs up to 2nd place.
• Formed the first autonomous team consisting of five analysts. This major structural change was very successful, and instructed others at various FDA locations on the formation of self-directed teams. The team had a record of over 95% completion of projects within time frames.
• Formed the first "Experimental Pharmapartnership" with some Pharmaceutical firms and Philadelphia FDA to meet and discuss such items as: Validation required in computer systems, validation of software updates, feasibility of "Drug Master File" concept for source codes and other proprietary programs.
• Assigned Chemists to domestic and international investigations, coordinating and negotiating with Investigations Branch and Headquarters International Division respectively.
• Directed the research projects conducted by the Laboratory.
• Interacted with foreign guests and dignitaries interested in comparing their own regulatory agencies to FDA.
• Hosted the Commissioner's counterparts from Kenya, Czech Republic, China, Armenia and others.

Chemist and Analyst on Special Assignments for Regional Director, 1989 - 1992

• Conducted a management review of supervisory persons which led to a major revision of assignments to streamline their work, primarily eliminating redundancies.
• Assisted in the establishment of a forensic program for generic drugs to insure regulatory compliance.
• Special projects relating to best management structure and assignments for the region. Much of this involved delegating more decision to lower levels.

Jay Associates and Seminars, 1982 - 1989

• Served clients in the areas FDA regulations, pharmaceutical new product development, marketing research and financial aspects of product development.
• Interfaced with FDA on such issues as: establishing Drug Master File (DMF), chemicals extracting from package into medicinal preparation and validation procedures.
• Prepared and delivered training seminars, courses taught: Effective Communications, Negotiating Techniques, Business Aspects of the Technical Function and Strategic Planning.

The West Company, Assistant Director of Laboratories, 1966 - 1982

• Leading manufacturer of elastomeric pharmaceutical packaging components. Held positions of increasing responsibility from Supervising Chemist of Quality Control, to Manager of Technical Services to Assistant Director of Laboratories in charge of Research and Development.
• Primary liaison with FDA and other agencies regarding regulatory situations.
• Responsible for hiring personnel, establishing capital and operating budgets, conducting market research and analysis of potential acquisitions.
• Planned and built a 4-group Research and Development department.
• Prepared the 5-year strategic plan for the company.
• Responsible for taking R&D projects through pilot plant to full scale-up in production and coordinating with marketing function.

Wyeth Laboratories, Senior Research Chemist, 1964 - 1966

• Designed analytical methods for new pharmaceutical raw materials and formulations.

SKF Industries, Research Chemist, 1961 - 1964

• Designed new methods and procedures for metals and lubricants.

Smith Kline & French Laboratories, Research Chemist, 1957 - 1961

• Designed analytical methods for new pharmaceutical raw materials and formulations.

Honors & Publications

Academic and Professional Affiliations

• Skidaway Institute of Oceanography (SklO)
• Institution Biosafety Committee (IBC)

Credentials

Completed various high level courses

• American Management Association's Executive Effectiveness Course
• FDA Executive Management Course
• FDA Law and Evidence Development Course

Publications

• Author of management books and detective novels.
• Author of several technical publications and poster presentations.
• Inventor and Owner of two patents.

Education

• MBA Marketing and Finance, Temple University, Philadelphia, PA
• M.S. Physical Chemistry, St. Joseph's College, Philadelphia, PA
• B.A. Chemistry, La Salle College, Philadelphia, PA