Recordings of Past Webinars
ISPE Members have the benefit of unlimited access to the webinar recordings 30 days after the live webinar. Each webinar will feature leading subject matter experts covering critical, relevant topics in pharmaceutical manufacturing.
COVID-19: Pharma Supply Chain Security & Robustness During Global Pandemic
Webinar recording available now!
Defining and Achieving Operational Readiness
Webinar recording will be available June 6, 2020
Sponsored By: CAI
Practical Implementation of the Lifecycle Approach to Process Validation
23 May 2020 - Lifecycle Process Validation guidance has been published by FDA in 2011 and by PIC/S and EMA in 2015. This guidance reflects ICH guidance on enhanced development and product quality monitoring practices using approaches based on Quality by Design.
Learn How Implementing Global Best Practices in Asset Management Improves Pharma Operations
27 April 2020 - Learn How Implementing Global Best Practices in Asset Management Improves Pharma Operations.
Blockchain for Pharmaceutical Engineers: An introduction to Blockchain Technology & the Potential for change to our Regulated Processes
19 February 2020 - The first part of the webinar will provide an introduction into the technology, demonstrate some of the technical components, and discuss use cases within the industry.
Strategies for Bringing Advanced Therapy Medicinal Products to Market
23 January 2020 - This presentation will showcase two case studies covering gene and cell therapies and tissue-engineered products which outline different strategies to bring these unique products/therapies to market.
Data Science Tools for Successful Technology Transfer
11 December 2019 - Learn how data science can be beneficial for successful tech transfer & get familiar with data science tool, such as comparability analysis, power analysis and integrated process modelling
Everything You Ever Wanted to Know about Pharma Water & Steam Systems…but Were Afraid to Ask!
21 November 2019 - Hear from the guide team leads themselves as they catalogue how the new Water and Steam Baseline Guide Vol. 4 (published in October 2019) is different.
ISPE Pharma 4.0 Operating Model – Basis for the ICH Holistic Control Strategy – An Introduction
16 October 2019 - The introduction of advanced automation and the increasing interconnectivity of Industry 4.0 is not only revolutionizing the Pharma industry but also introducing many new challenges and production roadblocks.
Qualification of PAT Based Control Strategies for Batch & Continuous Manufacturing
24 September 2019 - The purpose of this webinar is to provide practical examples highlighting different approaches how to commission, qualify and verify PAT systems designated for sophisticated control strategies in the most efficient and resource-saving way.
Polishing an Old Gem: Commissioning & Qualification Baseline Guide Update
21 August 2019 - This webinar will introduce the revision to the ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide was first issued in 2001 and reflective of that time.
GAMP® Good Practice Guide for GxP Compliant Lab Computerized Systems
25 June 2019 - This webinar will discuss the lifecycle of computerized laboratory equipment, with some discussion of the similarities and differences to computer system validation, and the use of quality risk management to right-size the effort, based on complexity and risks to data integrity.
New GAMP® Data Integrity Good Practice Guidance & Experience from the Field
30 May 2019 - This webinar provides an overview of new and forthcoming ISPE GAMP® Data Integrity guidance and real-world experiences on applying data integrity in the field.
Water for Injection Using Non-Distillative Methods – ISPE D/A/CH Approach
29 April 2019 - This webinar provides insight into the thoughts of the ISPE D/A/CH experts and additionally addresses the following questions: What are suitable technologies for the final treatment step of a cold WFI system?