The monthly webinars feature pharmaceutical professionals sharing their knowledge and expertise and are easy to access from any computer or electronic device. Registration is required but the webinars are free to both members and nonmembers. ISPE Members have the additional benefit of unlimited access to the webinar recordings, even if they were not able to attend. Nonmembers that attend a webinar have access to the recordings for 30 days.
The first webinar was an example of how the new series will be able to touch on current topics in a timely manner as speaker Fritz Röder talked about how highly purified water (HPW) had recently been deleted from the Pharmacopeia in Europe . Röder, Senior Manager Validation, Qualification & Engineering for Merck KGaA in Darmstadt, Germany, also included a regulatory overview of water for injection (WFI) including its history. A member of both the EDQM Working Group “Water” and ISPE DACH Expert Group “Water & Steam”, Röder is a recognized expert in the pharmaceutical industry and has extensive experience in water treatment &TCO measurement design.
The May webinar brought two data integrity experts, Sion Wyn a Director with Conformity Ltd. and Paul Moody a Director of Supplier Quality for Alexion Pharmaceuticals, Inc., together to discuss the new ISPE GAMP® Records and Data Integrity Guide. Both shared their own experiences of applying data integrity in the pharmaceutical industry and best practices including regulatory perspective, citations and problem areas, remediation actions and practical strategies.
Wyn is a well-known and internationally acknowledged specialist in computer systems validation and compliance and life-science regulation and the editor of ISPE GAMP 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems. Moody is a distinguished and respected specialist in life-science regulations with more than 20 years of experience in the pharmaceutical and medical device sectors.
ISPE members can still view these webinars on the ISPE website.
The June webinar brought two professionals, with more than 47 years of combined pharmaceutical industry experience, together to discuss the lifecycle of computerized laboratory equipment. Mark Newton, Principal, Heartland QA, has more than 30 years of pharmaceutical experience in QC Labs, computer systems validation and lab informatics. Paul Smith, Global Strategic Compliance Specialist, Agilent Technologies, has more than 17 years in the pharmaceutical industry and currently monitors laboratory compliance change and non-compliance trends.
Registration will be opening soon for the 21 August Webinar discussing commissioning and qualification. Complete the receive notifications form on the ISPE Webinars page to be the first to know when registration is open.
If you have questions or an idea for a webinar topic, let us know.
