An NSF International Company NSF-DBA’s Neil Wilkinson will be speaking at a forthcoming PDA conference
Monday the 9th July 2012
Neil Wilkinson our senior partner at the Boston office will be supporting the 2012 PDA-FDA ICH Q10 Workshop: Expectations of Operations & Executive Management, September 12 – 13 2012 in Baltimore, Maryland, USA by taking delegates through the background and history of ICH Q10 and why it is critical to both the regulators and the industry.
Neil was chair of EFPIA’s Manufacturing and GMP ad-hoc group and was EFPIA topic leader on the ICH Q10 Expert Working Group, who created the standard in 2008. Neil joins the FDA speaker in ensuring that the full implications of this standard are understood by industry leaders.
Here is a snapshot of the agenda but please read the full brochure (pdf file) for this exciting event aimed at industry senior management.
Wednesday, September 12
Session P1: Introduction & Quality Culture (1:15 p.m. – 2:15 p.m.)
Session Moderator: Anders Vinther, PhD, Vice President, Quality Biologics Operating Unit, Global Quality, Roche
Session Description: ICH Q10 is the first globally applicable guideline that clearly describes the role and responsibilities of senior management in terms of developing, communicating, leading, and continually improving the Pharmaceutical Quality System (PQS). The guideline extends significantly outside the basic GMPs described in the regulations and into how the PQS needs to be part of running the pharmaceutical operations business. In this session one of the authors of ICH Q10 describes why and how the guideline was established and FDA will provide thoughts as to how the PQS can be successful.
Overview of ICH Q10 – Why and How it was ‘Born’ (1:15 p.m. – 1:45 p.m.)
Neil Wilkinson, Senior Partner, NSF-DBA
What is a Good Quality System (1:45 p.m. – 2:15 p.m. )
Steven Lynn, Office Director (Acting), OMPQ, CDER, FDA
