AAHP GMP Compliance Seminar

A Look at GMP Requirements in the HPUS
Presented by George Bernstein, Ph.D.
President, MAI Consulting, Inc.

George Bernstein, Ph.D., is President of MAI Consulting, Inc., a consulting firm located in North Carolina. Dr. Bernstein has a Ph.D. in chemical engineering and more than 30 years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, effective training, and quality risk management. Since 1988, Dr. Bernstein has consulted internationally with major pharmaceutical companies. He has lectured internationally on quality systems and root cause analysis to industry trade groups, quality organizations, including the Parenteral Drug Association and at Interphex conferences.

Dr. Bernstein’s experience, insights, and innovative problem solving have been integral to his work, which ranges from training effectiveness, GMP compliance, facility design, construction, and commissioning to business process re-engineering and process optimization. He has developed global quality standards (GLP, GCP, GPP) for a major international pharmaceutical company, and has assisted many clients with audit preparation, remediation activities, and communications with the U.S. FDA.

Dr. Bernstein recently authored the following articles on LinkedIn: “FDA and Data Integrity — 3 Perspectives,” “API Manufacturing and Data Integrity — an Auditor’s Perspective,” “So, You Want to be a Consultant? Really?” and “Training Compliance vs. Training Effectiveness.” Additionally, Dr. Bernstein is a strong proponent of homeopathy.

Microbial Contamination
Presentation by Stephen E. Langille, Ph.D.
Senior Microbiology Consultant, ValSource, Inc.

As a senior microbiology consultant at ValSource, Inc., Dr. Langille specializes in microbiological and particulate matter contamination control. Prior to this position, he spent 19 years with FDA as a microbiology reviewer, branch chief, and director of the Division of Microbiology Assessment in the Center for Drug Evaluation and Research.

Dr. Langille is a member of the United States Pharmacopeia and Parenteral Drug Association working groups on particulate and microbiological manufacturing control and participating in the writing of the FDA’s draft guidance on Microbiological Quality Considerations in Non-sterile Drug Manufacturing.

With a B.S. degree in biology from the University of Massachusetts, Dr. Langille earned his Ph.D. in microbiology from the University of Maryland.

Compliance Trends
Presented by Tamara L. Ely
Branch Chief, Branch 6, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research

Ms. Ely received a bachelor’s degree in chemistry from West Virginia University in 1996 and a master’s degree in quality assurance and regulatory affairs from Temple University’s School of Pharmacy in 2005. She began instructing at Temple University in 2015. As an Adjunct Associate Professor, she co-instructs a course on Microbiological Concepts for Pharmaceuticals and Current Good Manufacturing Practices.

In her career, Ms. Ely has held various quality and compliance positions within the pharmaceutical industry: analytical chemist, certified quality auditor, compliance reviewer, CGMP and validation consultant.

Since 2010, Ms. Ely has worked in the Office of Manufacturing Quality in the Center for Drug Evaluation and Research (CDER) reviewing administrative and regulatory actions regarding adulteration, evaluating inspectional findings, and determining the acceptability of manufacturing facilities. In this role, she also participates in the development of science-based regulatory policy and guidance.