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 classroom course aims to deliver more than the usual project basics and will develop the concept of the project lifecycle from initiation through to delivery of business benefits, providing tools to manage all project resources. It is specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project management in the regulated pharmaceutical environment. Trends in regulatory compliance, environmental, health and safety legislation, project delivery methodologies and product speed to market expectations all impact how pharmaceutical facility projects are managed.
Dr. Trish Melton is Managing Director of MIME Solutions Ltd., an engineering and management consultancy providing project, programme & risk management, business change & improvement management, regulatory, validation and GMP consulting for pharmaceutical, chemical, and healthcare clients. She has previously worked for Eli Lilly and GSK, amongst others. Trish has worked as a project manager and project management consultant on engineering and non-engineering projects worldwide, predominantly within the global pharmaceutical & biopharmaceutical industry. She is a chartered Chemical Engineer and a Fellow of the Institution of Chemical Engineers (IChemE), where she was the founder Chair of the IChemE Project Management Subject Group and authored a series of IChemE publications, the Project Management Toolkit.
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.
This classroom course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies and problem areas related to the ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7 and the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Jack Chu has more than (30) years business experiences in Bio-pharm and Life Sciences Industries. After about (25) year services at Merck, Jack joined CAI (Commissioning Agents, Inc.) as Senior Consultant in 2017. Jack Chu is a licensed Professional Engineer. He has designed and implemented many significant projects worldwide since 1985. Jack also successfully led professional teams as expert witness for many complicated legal cases relating to engineering, technology, and operational issues. Mr. Chu is a leading expert in OSD (Oral Solid Dose Form) process development, quality assurance, facility & equipment system design and implementation, including manufacturing and technical operations. Jack is one of the strong advocates for “PAT Implementation”, “Single-use Technology Application” and “Continuous Manufacturing Process” for Pharmaceutical and Biological Manufactures. He brings many successful engineering solutions and recommendations to pharmaceutical industry and academia societies.
ISPE’s Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition) helps companies manage their risk of cross contamination by outlining a scientific, risk-based methodology based on ICH Q9 that can be used to lead teams through the process to satisfy auditors as well as global regulators. This classroom course will focus on using the logic diagram, how cross contamination control fits into the Quality System, how health-based limits are developed, setting cleaning validation limits, risk assessments for cross contamination and formulation a Quality Risk Management Plan.
Stephanie Wilkins, PE, Lean Six Sigma Green Belt, has over 30 years of professional experience in project management, risk management, engineering and validation solutions for the pharmaceutical and biotech industry including research, development, and pilot plant and manufacturing facilities. She is president of PharmaConsult US, Inc, which provides cross-contamination and containment consulting to the pharmaceutical industry. Wilkins, a member of ISPE since 1993 is the co-Chair of the ISPE Risk-MaPP Baseline Guide Task Team and was a member of the ISPE International Board of Directors. Wilkins is an ISPE trainer for Managing Cross Contamination and Risk-MaPP Principles. Wilkins also is a reviewer for articles to be placed in the Pharmaceutical Engineering Journal as well as contributed articles, given lectures and organized courses for ISPE. Wilkins graduated from the Pennsylvania State University with a Bachelor of Architectural Engineering.