Meet ISPE’s Featured Pharma Training Instructors

Sion is an acknowledged expert in computer system validation and compliance and international regulations in this field. He assisted the FDA as a consultant with its re-examination of 21 CFR Part 11 and was a member of the core team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He was the technical content expert for the FDA’s ORA Virtual University on-line training modules on computerized systems validation and compliance. He received the FDA Group Recognition Award for work on Part 11. Wyn is the editor of ISPE’s GAMP5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems and is a member of the ISPE GAMP Global Steering Committee, GAMP Editorial Board, and the GAMP Europe Steering Committee. He is lead GAMP and Computer Systems Validation and Compliance, Part 11, and Data Integrity trainer and course developer for ISPE. Most recently, Sion contributed to ISPE's 2019 Pharma Best Practices Webinar Series, presenting in the May 2019 New GAMP® Data Integrity Good Practice Guidance and Experience from the Field webinar.

Becky is the course instructor for the ISPE Cleaning Fundamentals class, and co-instructor with Chris McNulty for the ISPE Clean-In-Place course. Becky also teaches the PDA course on Cleaning Validation for Biotechnology. As VP of Strategic Practices for Quality Executive Partners, Becky works with customers to develop sustainable, compliant cleaning validation programs across a wide variety of manufacturing environments, including Biotech, traditional pharma, API production, medical device and in vitrodiagnostics. Her wider role within Quality Executive Partners, is to consult on sound compliant solutions in the areas of Validation, Quality Systems and Education. Becky has more than 30 years in the industry. Becky previously had worked for Dober Chemical Corporation, Raytheon Engineers & Constructors and Bristol-Myers Squibb.

Katherine has worked as a statistician in the pharmaceutical industry for over 18 years and has expertise across the product lifecycle, from product and process development through validation and commercial supply, as well as all stages of clinical development from First in Human through licensure and beyond. She holds a Master of Statistics degree from North Carolina State University, with a focus in biostatistics, and before starting in pharma she worked in survey research at the Research Triangle Institute.

Bruce is a professional engineer and has many years’ experience in the pharmaceutical industry and a wide international knowledge, and operates a consultancy in QbD, Engineering, Process Validation and reducing Human Error. He is an Associate to NSF-DBA, the training & consultancy Company. He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, and this extended to provision of sterile facilities. He has been a Member of ISPE since 1991 and is a Member of the United Kingdom Affiliate. He has held the position of Chair of ISPE International Board of Directors and has been active in supporting ISPE, including leading the team writing the original Sterile Baseline® Guide and its current update. He also led ISPE’s case study for practical implementation of Quality by Design (QbD) and co-chaired the team updating ISPE’s Technology Transfer Guide.