In this episode of Exceeding Your Benchmark podcast, our host Michelle Dawn Mooney dives into an engaging conversation with Fred Ayers, Advisor for Sterility Assurance for Global Quality Systems at Eli Lilly. Fred imparts valuable insights on the dynamic field of contamination control in pharmaceutical manufacturing.

Sheba Zaman of Novatek International is featured on the podcast to discuss how technology can provide visibility and powerful decision making for contamination control in pharmaceutical manufacturing. She explains the difficulties in the industry of digitalizing due to regulations, product safety and taking liability into account. Additionally, she discusses how utilizing data lakes and connecting elements of contamination control can provide insight and trend analysis.

The Exceeding Your Benchmark podcast interviews Jim Fries, the CEO of Rx360, a non-profit that works with pharmaceutical companies and their suppliers worldwide to protect patients from pharmaceutical-related safety issues. Jim explains the Joint Audit Program which is used to assess the quality of manufacturing facilities for pharmaceutical products.

In this episode of Exceeding Your Benchmark, Ashley Harp, Lead Process Engineer at CRB, talks about the challenges of pharmaceutical manufacturing adapting to rapid innovation of new therapies and various options to meet demand.

In this episode of Exceeding Your Benchmark, Sumit Verma, Senior Vice President Global Strategic Manufacturing at Iovance Biotherapeutics, talks about the challenges faced by new biopharma startups and how cell and gene manufacturers can scale to meet demand.

Podcast Host Gabrielle Bejarano talked to Chris White, who is the Global Head of GMP at Adamas Consulting, about what’s new and different in Annex 1, and how sterile manufacturing companies and facilities can meet the regulations by the summer of 2023.