ComplianceOnline

Expert Profile


Mark Trotter
Proven Marketing and Sales Professional delivering complex process solutions, BioPharma Industries

Mark Trotter, with over twenty years’ experience in the pharmaceutical and life science industries, has a broad range of work experience, from pharmacologic chemistry research project leader to marketing management in the laboratory and process equipment industries. This extensive background in the biopharmaceutical sciences is coupled with an in-depth regulatory knowledge that supports his expertise in these areas of process validation and qualification.

He has specialized training and work experiences in filter membrane technologies, including sterilizing, prefiltration, chromatography as well as single-use disposables technologies. Upstream fermentation to downstream applications, including separations, clarification and purifications processes technologies, are areas of subject matter expertise he brings to the training, technology transfer and consulting services. He completed his post-graduate studies at Long Island University, C.W. Post College, earning his MS in Medical Microbiology and continuing on for his MBA in Finance.

Mr. Trotter has published numerous technical articles, book chapters and has contributed expert editorial comment on these subjects. He is a member of PDA (Parenteral Drug Association), ASM (American Society of Microbiology) International Society for Pharmaceutical Engineering, (ISPE.), and the American Society of Quality, (ASQ), serving on ASTM E55 Biopharma Group and the USP Filtration Expert Panel.

Trainings by Expert

Single-Use Systems and Technologies
Category: Drugs and Chemicals (Pharma) , Biotechnology , All FDA Regulated Industry , GXP Pharmaceutical , Quality and Safety , Drug Development , Quality & Safety , Drugs Regulations , Biotech Regulations , Life sciences QA/QC , Research & Development , Drug R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Sterilizing Grade and Prefilter
Category: Drugs and Chemicals (Pharma) , All FDA Regulated Industry , GXP Pharmaceutical , Quality and Safety , Supply Chain and Manufacturing , Drug Development , Drugs Regulations , Life sciences QA/QC , Research & Development , Drug R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Extractables and Leachables - Biopharma Polymeric Devices
Category: Drugs and Chemicals (Pharma) , Biotechnology , All FDA Regulated Industry , GXP Pharmaceutical , FDA Validation , Quality and Safety , Drug Development , Quality & Safety , Drugs Regulations , Biotech Regulations , Life sciences QA/QC , Research & Development , Drug R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC