24 February 2022 - 24 February 2022
STERIS WORKSHOP - Disinfectant Validation and Efficacy Testing 24 Feb 2022 9.30-11.00 am SGT | Online This presentation covers: Current debates in the industry regarding disinfectant coupon testing. PDA Technical Report No. 70 and USP 43 <1072> in...
20 January 2022 - 20 January 2022
An Introduction to GxP There are a lot of three-letter acronyms employed in biotech – GMP, GLP, cGMP, CFR, etc. – that can be hard to keep straight when getting into the industry. Whether you're new to the industry or need a quick refresher, join the...
iSpeak Blog

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from November 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

Biopharmaceuticals: Introduction to Large Molecule Therapeutics Training Course Overview This new online course introduces participants to the development of biopharmaceuticals and it will cover concepts that highlight the differences between small molecules and biomolecules (large molecules). The...
iSpeak Blog

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are some great reading selections for the holidays! This year’s holiday topic: biopharma, cell and gene therapies, and ATMPs. That topic is the theme for the November-December 2021 issue , and here are some earlier articles on these important and timely topics.

The Guide has been revised to align with current industry practice, particularly with respect to the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition), presenting a cost-effective way of demonstrating and maintaining compliance. The most significant changes are:
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The "ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management" discusses how critical thinking based on product and process knowledge and quality risk management can enable...
iSpeak Blog

Competitive advantage and sustained business results depend on leaders building and maintaining a strong culture. This has been reinforced by the increased challenges in attracting and retaining talent. The FDA is also placing significant focus on Quality Management Maturity. But how do leaders know if they are on track? Assessing leadership systems is often overlooked or much more difficult...

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