Quality management is a critical component within the pharmaceutical industry, particularly for manufacturing operations and regulatory compliance. It has relevance for the safety of drug products themselves but also in the handling of data too.

As digitalization continues to play a greater role in modern quality management processes, pharma employees must have up to date knowledge to maintain their effectiveness and improve efficiency as technology advances.

This webinar reviews the main trends and latest guidelines affecting managing quality procedures in pharma, such as Annex 1 for Europe. The session explores how the industry is handling implementing ICH Q12 and life cycle management, as well as the continuing global impurities story of nitrosamines and the risks they pose.

This webinar also discusses artificial intelligence (AI): how the industry is navigating this technology alongside the integration of Industry 4.0, as well as the impact of AI on chemistry manufacturing and controls (CMC) and what the concerns are around data integrity.

The session also highlights some of the key quality topics and themes shared during the National Biotechnology Conference and PharmSci360.

Learning Objectives:

• Learn how global guidelines from Annex 1 to the latest ICH Q12 requirements impacting pharmaceutical quality control
• Discover the potential impact of artificial intelligence on chemistry manufacturing and controls
• Find out what key quality issues are impacting the pharmaceutical sector with an update from recent industry conferences.

Speaker: Tina Morris, Ph.D.

Dr. Morris is the Executive Director of the American Association of Pharmaceutical Scientists (AAPS). She leads the staff team that supports all operational aspects of the Association and works with the AAPS Board of Directors and other Volunteer Leadership Committees on the strategic and direction-setting activities that guide the work of the scientific society. Prior to that, she was Vice President of Scientific and Regulatory Affairs at the Parenteral Drug Association (PDA). Until 2018, Dr. Morris held several scientific senior leadership positions at the United States Pharmacopeia (USP), including as the Global Head of Biologics and Senior Vice President of Compendial Science. Before joining USP in 2003, Dr. Morris worked in the biopharmaceutical industry, with an expertise focus on analytical development and product characterization. She completed her postdoctoral research at the National Institutes of Health. She holds a Ph.D. in molecular virology from the Medical University of Luebeck, Germany, and a master’s degree in biology from the Carl von Ossietzky University of Oldenburg, Germany.

Moderator: Catherine Eckford

Editorial Assistant, European Pharmaceutical Review