1VQ Solutions: an Enhanced Science and Risk-Based Approach to Post-Approval Changes – Part 2

This week, Stacey is joined by Emma Ramnarine to continue their series discussing One-Voice-of-Quality. This discussion focuses in on the details for a greater understanding around the how’s and who’s that are necessary to this One-Voice-of-Quality vision.

Emma has over 15 years of experience in the pharmaceutical, biotechnology and medical device industry in the area of Quality System with focus on developing and leading Quality Risk Management (QRM), validation, and change control. She is a worldwide-recognized expert on QRM, providing QRM leadership, governance, guidance, and training to regulatory authorities and at industry forums. Emma has been an active member of the Parenteral Drug Association (PDA) for 13 years. She most recently led PDA”s Task Force for Technical Report No. 68 on “Risk Based Approach for Prevention and Management of Drug Shortages” and is also a member for PDA on the inter-association European Drug Shortages Team that was formed under EMA”s direction. She also led the Task Forces for PCMOSM Technical Report Series No. 54 on “Implementation of Quality Risk Management”. Emma joined the PDA Board of Directors as of Jan 2015, has been on PDA”s Regulatory Affairs and Quality Advisory Board (RAQAB) since 2013, and also co-leads PDA”s QRM Interest Group. Emma holds an M.S. in Pharmaceutical Sciences from University of Connecticut, an M.S. in Medicinal & Pharmaceutical Chemistry, and a B.S. in Pharmacy, both from University of Indore, India.

Read more from Emma on this topic:
1. Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based Approaches
2. Industry One-Voice-of Quality Concept Paper: Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transforms Post-Approval Change Management
3. Continual Improvement While Maintaining A State of Control: A Concealed Paradox or a Mutual Interdependence?
4. Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction.
5. PDA PAC iAM 2017 Survey on Post-Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry
6. PDA Technical Report 68: Risk-Based Approach for Prevention and Management of Drug Shortages

Website link to discussion topic: https://prst.ie/1vq

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

#1VQ
#IVTNetwork
#Pharma

Видео 1VQ Solutions: an Enhanced Science and Risk-Based Approach to Post-Approval Changes – Part 2 канала Risk Revolution