COVID-19: Pharma Supply Chain Security & Robustness During Global Pandemic Webinar

Presented on April 2, 2020 - Webinar recording available now!

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Risk Based Approach to Mitigate SARS – COV-2 Challenge to the Virus Control Framework in Industrial GMP Manufacturing Facilities Webinar

Presented on June 11, 2020 - Webinar recording available now!

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Creating a Vision of the Future – An Evolution or Revolution of the Pharmaceutical Supply Chain Panel and Fireside Chat Webinar

Presented on June 18, 2020 -  Webinar recording available now!

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Demystifying Your Questions on Revised Commissioning & Qualification ISPE Baseline Guide Vol. 5 Webinar

Presented on 7 July, 2020 - Webinar recording will be available 7 August

Overview

GAMP®5, FDA CSA, and the Future of Computer Systems Validation Webinar

Extended Learning

Presented on July 29, 2020 - Webinar recording will be available 29 August

Overview

Improved Process Performance through Implementation of Rapid Microbiological Detection Methods Webinar 

24 June, 2020 - Hold times caused by micro QC test have a significant impact on the manufacturing cycle. Many companies try to overcome this bottle neck by choosing a “continue at risk” approach because for a long time this was the only option that was available. Due to the advent of more advance micro QC test methods, manufacturers do not need to accept the risk anymore as shorter time to result makes results available which allow for data driven decisions.

Selection of Single-Use Components Webinar 

21 May 2020 - Implementation of Single-Use Systems (SUS) starts with an effective selection of Single-Use components. This webinar highlights criteria to select and qualify Single-Use components. It expands on topics introduced in the ISPE Good Practice Guide: Single-Use Technology that lead to improved design and utilization of Single-Use systems in production processes.

Defining and Achieving Operational Readiness Webinar 

6 May 2020 - Session will provide insights to help you develop your definition of operational readiness and assemble your readiness plan that identifies the coordinated workstreams of action to achieve readiness.
Sponsored By: CAI

Practical Implementation of the Lifecycle Approach to Process Validation Webinar 

23 April 2020 - Lifecycle Process Validation guidance has been published by the 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 Webinar 

26 March 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 Webinar 

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 Webinar 

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 Webinar 

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! Webinar 

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 Webinar 

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 Webinar 

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 Webinar 

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 Webinar 

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 Webinar 

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 Webinar 

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?