PharmaLex US

// New! Read the eBook from subject-matter expert Gerardo Gomez, Ph.D. from regulatory consultancy PharmaLex which provides insight into key concepts in aseptic processing and current trends in their application, including special considerations for aseptic processing of ATMPs.

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In this eBook, Gerardo offers valuable impressions on commissioning, qualification, and validation (CQV) from the 2023 Society for Pharmaceutical Engineers (ISPE) Aseptic Conference in Bethesda, MD. The meeting convened presenters and delegates from the world over to discuss recommendations for aseptic-process simulation (APS), novel isolator and restricted-access barrier (RABS) systems, implications of the 2022 update to Annex 1 of the EU good manufacturing practice (GMP) guideline, and more. Read the eBook now to learn about key concepts in aseptic processing and current trends in their application, including special considerations for the aseptic processing of ATMPs.

https://bioprocessintl.com/multimedia/ebooks/ebook-aseptic-processing-reflections-from-the-2023-ispe-aseptic-conference/

Book a meeting with Gerardo to explore your Quality, Management, and Compliance (QMC) projects today!

[email protected]/bookings/s/MqM7033nQU2C6gFfFCFZ0A2" rel="ugc" target="_blank">https://outlook.office365.com/owa/calendar/[email protected]/bookings/s/MqM7033nQU2C6gFfFCFZ0A2

// Regulatory precedent research plays a crucial role in supporting regulatory science and product development strategies. This webcast highlights the available tools and approaches for conducting regulatory precedent research and describes their utility to inform decision-making in the biotechnology and pharmaceutical industry. Understanding and leveraging regulatory precedents can enhance regulatory intelligence, facilitate informed decision-making, and contribute to the development of innovative and safe therapeutic products.

Register for the RAPS Indiana Chapter’s webcast now for RAC credits on “Utilizing Regulatory Precedence for Decision Making” Monday Monday, 25 Sep 2023 (03:30 PM – 5:00 PM EST) featuring PharmaLexperts Renata Kover and Anusha Kesireddy.

Learn more about Regulatory Affairs and CMC at PharmaLex.

Indiana Chapter Webcast: Utilizing Regulatory Precedence for Decision Making This webcast highlights the available tools and approaches for conducting regulatory precedent research and describes their utility to inform decision-making in the biotechnology and pharmaceutical industry.

// Exciting News! Check out this insightful article in the August issue of Pharmaphorum published by Michelle Anastasi at PharmaLex: "4 Questions to Determine the Health of Your Company's QMS (Quality Management System)."

Michelle Anastasi, https://www.linkedin.com/in/anastasim/ a seasoned expert in Quality and Compliance dives deep into these questions, providing invaluable insights and actionable strategies to boost the health of your QMS.

Is your Quality Management System (QMS) in tip-top shape? Get ready to enhance your understanding of QMS with these 4 essential questions:

1. Do you have a Quality Policy and/or Quality Manual, approved by senior/executive management, and issued within the past three years?
2. Are all controlled documents (SOPs, policies, work instructions, etc.) reviewed every two to three years by document owners in collaboration with quality assurance personnel?
3. Does the CAPA and/or investigation procedure give a step-by-step description of how to conduct root-cause analysis while identifying effective CAPAs, and assessing the impact on products and processes consistently in every investigation?
4. Is a Quality Management Review conducted periodically, involving senior management, and does that review result in continuous improvement?

Read the full article here: https://pharmaphorum.com/market-access/4-questions-determine-health-your-companys-qms

Don't miss out on this opportunity to elevate your QMS game! Learn more about Quality and Compliance at PharmaLex: https://www.pharmalex.com/pharmalex-departments/quality-management-and-compliance/