Data Integrity – Insight into the NEW ISPE GAMP® Records and Data Integrity Guideline
Sponsored by: Dassault Systèmes - BIOVIA
- Data Integrity
Date: 25 April
Time: 3PM London/10AM New York
ISPE is at the forefront of risk based guidance, ensuring that industry implements an effective and pragmatic response to regulatory expectations. ISPE GAMP® will publish a Records and Data Integrity guideline in April 2017. This webinar provides an opportunity to understand the key concepts of the guideline that will ensure an effective data integrity strategy within your organization.
This webinar provides valuable insight into industries response to effectively managing data integrity within your organization. The webinar will be of value to all personnel involved in the data lifecycle including those involved in organization management, production, quality control, quality assurance, solution implementation and solution support.
Integrity Solutions Ltd, GAMP Global Steering Committee, ISPE International Board of Directors
Chris Reid is CEO of Integrity Solutions Limited, a provider of Quality and Compliance solutions to regulated companies globally. Integrity Solutions is located in the UK, Tokyo and North Carolina. Chris’ responsibilities include all aspects of business management, financial management, resourcing and product / service development. Chris has worked for over 50 regulated companies from small local companies to multinational pharmaceutical enterprises.
Chris has worked in Life science industries over 20 years, prior to which he was a computerised system development engineer. Chris currently works with leading global organisations developing and implementing quality and compliance solutions including defining and implementing strategic quality initiatives, implementing corporate quality policies and standards, skills development and system validation.
Chris works with a variety of organisations and disciplines including IS/IT, Engineering, Business, QA and Suppliers. Chris has worked across pharmaceuticals, biotechnology, medical devices and cosmetic industries and all regulatory domains including clinical, laboratories, manufacturing, distribution and pharmacovigilance. Chris is a member of ISPE’s International Board of Directors, ISPE European Forum, ISPE Leadership Team, Former Co-chair of the Knowledge Network Council and member of the Global and European GAMP Steering Committees. Chris has contributed to the development of GAMP 5 and a variety of GAMP Good Practice Guides.
Key Learning Objectives
- What the new ISPE GAMP Records and Data Integrity Guideline covers
- Expectations of global regulators
- Key data integrity principles and concepts
- Considerations for a data integrity programme within your organisation
- Head of IT/IS
- Chief Information Officer
- Head/Director of Quality/Quality Operations
- VP Quality
- Head/Director of Manufacturing