BioPharma BoardRoom’s Post

View organization page for BioPharma BoardRoom, graphic

3,055 followers

In this talk, an approach consisting of a digital loop is presented, leveraging ICH Q9(R1) and ICH Q13 regulatory packages, integrating process data acquisition (via Continued Process Verification plan, for example) and Quality Risk Management systems. This retrofitting digital loop, rooted within the company’s Pharmaceutical Quality System, will enable companies to dynamically refine process control strategies supported by process insights and data, which are then incorporated in a pre-defined formal structure; thus, enabling the expected formal flexibility and reducing subjectivity for quality decisions, both critical concepts for efficient CM processes and safety and efficacy of the final product. Maria Batalha Kevin Bittorf Matthew Mollan John Nadzam #INTERPHEX24

Industry Titans Illuminate Path to Pharmaceutical Innovation at INTERPHEX 2024

Industry Titans Illuminate Path to Pharmaceutical Innovation at INTERPHEX 2024

biopharmaboardroom.com

To view or add a comment, sign in

Explore topics