Frank Böttcher, PhD

Frank Böttcher is an active member of various working groups that focus on the testing of medicinal products and medical devices. His other areas of expertise include contract agreements in the area of contract manufacture and testing as well as the manufacture and testing of sterile products.

Frank Böttcher started his professional career in the pharmaceutical industry in 1994, his first position involving the analysis and approval of phytopharmaceuticals. He then held different positions in an international company and at a contract manufacturer where he was responsible for supplier management and the control and approval of packaging materials, starting materials and finished medicinal products.

In 2003, he joined Labor LS SE & Co. KG where he was responsible for quality assurance, the testing of sterile products and chemical and physical analysis.

From 2005 to 2019, he was a member of the board, CEO and later managing director for various areas of the company, e.g. the operational business, quality control, personnel and finance. In 2020, he worked as a freelance consultant for the pharmaceutical industry and medical device manufacturers.

Frank Böttcher has a wealth of experience in the area of auditing and official inspections. In addition, he works as a speaker and author with a focus on quality assurance, risk management, validation, verification and transfer of analytical processes.

He is author or co-author of the following chapter of GMP Compliance Adviser:

• 1.L Outsourced activities
• 14.A Sampling
• 17.B Contract Analysis