2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More

About the Author

Vice President Vetter Development Service External Affairs

Vetter Pharma Fertigung GmbH & Co KG

Jörg Zimmermann is currently Vice President External Affairs for Vetter Pharma Fertigung GmbH&Co KG, Ravensburg, Germany. In this role, he manages the relationships with regulatory...

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Hands-on Innovation Management with the ISPE Hackathon

21 November 2023

Innovation is an integral part of corporate strategy. Initiatives to facilitate innovation are continually developed and pursued. The 2022 ISPE Pharma 4.0™ Emerging Leader (EL) Hackathon was designed based on innovator needs and provided a hands-on blueprint manufacturing exercise. Over a period of two days and facilitated by 40 subject matter experts, coaches, and jury members, 50...

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FDA Regulatory Panel: 2023 ISPE Aseptic Conference

1 September 2023

On 7 March 2023, ISPE continued its tradition of concluding the 2023 ISPE Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to the FDA representatives. This article offers highlights from the discussion.

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A Patient-Centric Review of ICH Q6A and ICH6B

1 September 2023

The ICH Quality Discussion Group (QDG) has recommended contemporizing the specification setting guidelines ICH Q6A and Q6B. This provides an excellent opportunity to update ICH Q6A/B to align and work in a complementary manner with the science-, risk/knowledge-based concepts in ICH Q8–Q12. The ISPE Pharmaceutical Quality Lifecycle Implementation (PQLI) Patient-Centric Specification working...

About the Author

Facilities of the Future: Meeting the Demands of Breakthrough Therapeutics

Emerging Leader Hacker to GAMPer in 10 Weeks

New Initiative Seeks to Back up ICHs Harmonization Mission

Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization

Entering a New Era of Innovation and Collaboration With the Focus on the Workforce of the Future

Q&A with ISPE Foundation Professional Development Grant Recipient Silas Tamufor

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