ComplianceOnline

Expert Profile


Jeffrey Staecker
Principal Consultant, BioPhia Consulting

Jeff Staecker has worked in GMP industries for over 25 years whose experience covers a breadth of functional responsibilities (QC, QA, R & D, manufacturing) as well as working for manufacturers, a contract testing organizations, and contract manufacturing organization. Responsibilities have included oversight of groups of more than 70 individuals, large budgets, as well as individual responsibilities such as leading risk assessments, technology transfer, and consent-decree remediation activities. Jeff has had multiple roles in method transfers for more than 20 years and recently (January 23) co-chaired and presented at an international meeting “Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry” (http://www.casss.org/page/CMCJ1700).

Trainings by Expert

Risk-based Approach to Biopharmaceutical Method Transfers
Category: Drugs and Chemicals (Pharma) , Biotechnology , All FDA Regulated Industry , GXP Pharmaceutical , Quality and Safety , Supply Chain and Manufacturing , 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

Use of SPC in the Biopharmaceutical industry: use and implementation
Category: Drugs and Chemicals (Pharma) , Biotechnology , Testing and Validation , Documentation and IT , Quality and Safety , Quality & Safety , Technologies and Processes , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Life Sciences , Documentation and Data Management , QA/QC