David Margetts is the CEO of Factorytalk, and an advisor, consultant, and technical expert in the areas of compliance and information technology. David’s background and...
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...
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.
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...