Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
Using case studies and exercises this course in facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products. The course includes a review of biopharmaceutical manufacturing facility design and regulatory issues important in the US and Europe that involve industry trends and changing regulatory policy. Participants will discuss current case studies on a wide array of facility topics, and complete class exercises that involve developing facility scope of work and deliverables to meet corporate economic goals and regulatory requirements.
Mark von Stwolinski is the Vice President of Architectural Services at Clark Richardson & Biskup (CRB) Consulting Engineers. He has over 22 years of experience in the design and construction of biopharmaceutical facilities worldwide. His experience with ISPE guidance documents includes: Steering Committee member and contributing author for five ISPE Guides, Chair and contributing author for the new ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities, issued in 2013.
This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins.
Rusty Morrison is an experienced pharmaceutical professional with over 30 consecutive years of experience at all levels in technology transfer, CMC project management, process validation, commissioning, qualification, validation, engineering, and manufacturing. Significant biopharmaceutical experience includes managing a bulk drug substance site-to-site tech transfer; managing early-stage RNA interference CMC activities for multiple products in the development pipeline; multiple assignments managing teams providing risk-based validation, commissioning, and engineering services for mammalian cell culture facilities; and serving as Director of Facilities & Engineering for a startup vaccine manufacturer.
This GAMP 5 GxP Process Control Training Course describes how the GAMP® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems, may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements.
Mike Byrd, the Director of Computer System Validation (CSV) for ProPharma Group</b> has over 25 years in the pharmaceutical and biotechnology industries, and over 30 years of information systems experience. Mike’s educational credentials include a Bachelor of Science in Chemistry and a Master’s in Business Administration with an emphasis in Technology Management. Mike has developed, implemented, administered, and validated a wide variety of computer-based solutions supporting critical regulated business processes.
This classroom course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. In addition, the course identifies the long list of activities required to validate biopharmaceutical processes.Topics include a comprehensive strategy to process validation; a review of important biotechnology manufacturing processes, and the regulatory requirements for their validation.
Jefferey Jones, Executive Director of Quality at Humacyte, Inc., has over 20 years of experience with development-stage and commercial biopharmaceutical process technology transfer. In his current role, Jefferey oversees Quality aspects of facility, process, and instrumentation design and scale up for a novel biologic process manufacturing bioengineered blood vessels.
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.