Course Description

Best Practices for Manufacturing Active Pharmaceutical Ingredients

November 1-3, 2017
New Brunswick, NJ

Course Offering 171101NJ2742
Course ID 2742

In-Person Course

Who Should Attend?
This course is designed to inform those experienced in Active Pharmaceutical Ingredients (API) manufacturing about the shifting paradigm due to globalization and enlighten those who are entering a career in this exciting field of API manufacturing:
  • Pilot and commercial production
  • QA/QC
  • Technical services
  • Regulatory affairs
  • Process development
  • Validation
  • Regulatory agency investigators

The presenters discuss the many ways that roles and responsibilities for individuals and departments are changing now to achieve a successful and compliant API operation in the 21st century.

Course Description
This 3-day intensive course prepares attendees to meet the challenges they face in the heavily regulated pharmaceutical industry. API manufacturers must be aware of local, regional and national regulatory agencies’ enforcement activities that are applied to API production and develop a strategy to compete successfully in the current world economy. Manufacturing in the 21st century is shifting from manual processes that depend on subjective decision-making to automated processing that provide greater control and flexibility. This new paradigm focuses on product life-cycle from development activities to commercial production and finally product discontinuation.

The initial topic discussed is management’s roles within the organization and outside of the organizational structure that contribute to the success of the operation. Other topics focus on the various manufacturing functions using classical, enhanced or a combination approach. Risk management is an important tool in the decision making process related to quality and production systems development that emphasizes patient safety and helps to maintain a healthy regulatory environment. Throughout the program there are interactive class exercises. On the last day of the course, participants are put into small groups and each group receives a list of simulated regulatory observations based on actual inspections. The groups evaluate the observations and then prepare a written response to the regulatory authority explaining their activities to remediate the deficiencies. The exercise is a valuable opportunity to develop approaches with your colleagues and build lasting contacts.

Course Director
Richard G. Einig, Ph.D., RAC, CQA, Pharmaceutical Quality Assurance Consultant

Richard G. Einig, Ph.D., RAC, CQA is a consultant specializing in the pharmaceutical and veterinary medicine industries. His experience spans over twenty years in senior management of quality, regulatory, and development units of large international companies and start-up “biotechs”. He has worked internationally with innovator and generic dosage form companies, medical device manufacturers and research organizations. Dr. Einig participated in developing the PhRMA Bulk Pharmaceutical Committee’s Guidance on Production of Drug Substance, and is an invited speaker at domestic and international meetings on quality and processing of pharmaceutical products. Dr. Einig is a member of the American Chemical Society as well as a member and carries certifications from the American Society for Quality, the Regulatory Affairs Professional Society, and the Institute for Independent Business. He received undergraduate and graduate degrees in Chemistry from St. Louis University, MBA from Webster University, and Ph.D. from Missouri University.

Additional Faculty
Michael Day has a thirty year career associated with process development and manufacturing in the pharmaceutical business. He was responsible for U.S. API production for Hoechst-Celanese Corporation and manager of Technical Services for Searle/Pharmacia/Pfizer at the Augusta, Georgia facility. He has extensive experience in the area of technical transfers and associated quality systems that supported commercialization of those products. He is currently consulting and teaching in the pharmaceutical arena.

Venue Information
New Brunswick, NJ Area
Hotel Information sent with
course confirmation package