Join us before the conference as we take a deeper dive into critical areas of Biotechonology
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 S. Von Stwolinski, RA
Vice President Facility Integration
Mark von Stwolinski is the Vice President of Architectural Services at Clark Richardson & Biskup (CRB) Consulting Engineers. He has over 20 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 three ISPE Guides, Chair and contributing author for the new ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities, issued in 2013, ISPE Course Instructor for the 2-day Sterile Product Manufacturing Training Course in North America, Member of the ISPE Guidance Document Executive Committee (GDEC) and Lead Process Architect for CRB.
The inherent complexity and uncertainty of biotechnology makes developing and validating bioprocesses for manufacturing proteins and biopharmaceuticals very difficult. Understanding and using USFDA's Process Validation Guideline is critical to establishing and maintaining control of complex processes, as well as achieving regulatory approval of new products. This course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. Course topics includes a long list of activities required to validate biopharmaceutical processes; a comprehensive strategy to process validation; a review of important biotechnology manufacturing processes, and the regulatory requirements for their validation. In addition to classroom lectures, participants will take part in several interactive exercises, solve group problems, and participate in class discussions to understand the underlying principles behind Process Validation. For this advanced course participants should have a basic understanding of C&Q, validation and basic familiarity with biotechnology manufacturing processes and unit operations.
Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8 (R2), Q9, and Q10 and ASTM E2500. Topics covered include the principles and activities that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness for use as required by major global regulatory authorities; improving the ability to meet documented process requirements; controlling risks within the manufacturing process; producing high quality products and consistent operation to meet product user requirements. Guidance on the transition of an organization’s approach to Commissioning and Qualification to one that incorporates a science and risk-based approach will be discussed.
Managing Director and Consultant
VCD Validation Services Ltd
Veronica Power, Managing Director and Consultant at VCD Validation Services Ltd., is an experienced engineering professional with 20+ years of experience providing technical and consulting services to the pharmaceutical and biotechnology industries. She is a founding member of the Ireland GAMP COP Committee with significant experience of project planning and coordination.Veronica has a deep understanding of oral solid dosage, dry powder inhaler, metered dose inhaler, medical device, aseptic processing, packaging and labelling operations.
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.
Williams Process Limited
Bruce Williams is a consulting chemical and process engineer, fellow of the Institution of Chemical Engineers, and past chair of ISPE’s United Kingdom Affiliate. He specialises in industrial and pharmaceutical biotechnology, having spent 10 years in contract manufacturing with AstraZeneca and Avecia. There he was responsible for the process engineering and technology transfer activities in the business. He founded Williams Process Limited in 2008, to help companies to achieve Efficient, Effective and Compliant processes. Bruce is also an industrial lecturer at the Newcastle University Biopharmaceutical Bioprocessing Technology Centre.