Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
Join us as we take a deep dive into critical areas of pharmaceutical manufacturing at the ISPE Bethesda Training Facility located at 6110 Executive Blvd, Suite 600, North Bethesda, MD 20852.
This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication. Additional content includes elements of a cleaning validation program from start to finish, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes and the establishment of scientific rationales acceptable to regulatory inspectors.
Rebecca Brewer has more than 29 years of experience in validation and compliance within the pharmaceutical, biopharmaceutical and medical device industries. As a consultant, Becky has had the opportunity to audit, develop and provide training in validation and compliance programs for a large variety of companies and products. Becky’s work has led to the development of procedures and policies in some of the most challenging environments, including: research and development, contract manufacturers and suppliers. Becky is the current instructor for ISPE’s Cleaning Validation Educational course and PDA’s Biotechnology Cleaning Validation course. She also frequently conducts site-specific validation and GMP compliance training for individual companies.