Join us after the Biopharmaceutical Manufacturing Conference as we take a deeper dive into critical areas of Biopharmaceutical Manufacturing.
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 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.
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. The course studies commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion and adsorptive chromatography.
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.
This interactive classroom course will provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program. Through interactive workshops, participants will more fully understand and apply the principles of ASTM E2500-07 and ICH documents (Q8 (R2), Q9, and Q10) to the documented verification of pharmaceutical and biopharmaceutical facilities, systems and equipment that are suitable for their intended purpose.
Dan Franklin, CIRM, CxA is the Regional Manager of Integrated Project Services’ Midwest US Commissioning and Qualification operations based in Indianapolis, Indiana. Current responsibilities include consulting; and program planning, delivery and execution support for capital projects and risk-based verification programs.
Due to the growing pressures from global competitors, high marketing demands, and the requirements of GMP compliance, the bio-pharm industry (brand drugs and generic drug companies) are looking beyond the usual group of closely-knit suppliers. India and China engage in bulk activities and have been generating new dimensional API products with more specialized capabilities than those required by traditional drug products. In order to remain competitive, API manufacturers will need to attune themselves to this evolving dynamic global market. 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.