This week, Stacey is joined by Marty Lipa, Executive Director Knowledge Management, Merck & Co. Stacey and Marty discuss the importance of “managing knowledge as an asset” in the pharmaceutical industry and learn how every company can begin to capitalize on this very important product.
1. Link to ICH Q10: https://database.ich.org/sites/default/files/Q10%20Guideline.pdf
2. Link to find out more about the Knowledge Transfer Enhancement Framework (Chapter 6): https://arrow.tudublin.ie/cgi/viewcontent.cgi?article=1011&context=ditpress
3. Effective Knowledge Transfer During Biopharmaceutical Technology Transfer: https://www.ivtnetwork.com/article/effective-knowledge-transfer-during-biopharmaceutical-technology-transfer
4. Managing Knowledge and Risk – A Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers: https://www.ivtnetwork.com/article/managing-knowledge-and-risk-%E2%80%93-literature-review-interdependency-qrm-and-km-ich-q10-enablers
Marty has over 25 years’ industry experience and 12 years’ experience in Knowledge Management. He has published several industry specific works and is currently pursuing his Ph.D. at Technological University Dublin in Pharmaceutical and Regulatory Science with an emphasis on Knowledge Management. Lipa also leads the Knowledge Management Center of Excellence for the Manufacturing Division of Merck & Co., Inc.
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.
Risk Revolution part 2
Identification and Management of Critical Data
Grouping Products & Equipment for Cleaning Validation & Selection of Worst-Case Parameters
You Are What You Eat: Food Contaminants and Food Safety in the Manufacturing Facility and Home
Effective Audits in the Medical Device Industry
Risk Revolution part 1
Microbiological Risks Associated With Pop-Culture Trends
1VQ Solutions: an Enhanced Science and Risk-Based Approach to Post-Approval Changes – Part 2
Validation Week Awards
A Life Cycle Approach to Cleaning
Customized Medicines for Personalized Treatments
QRM Series - Risk Revolution: Back to Basics
Contamination Control and Sterility Assurance for Compounding Facilities
Drug Preparation and Administration – Insourcing Ready-to-Administer Syringes with IV Robotics
1VQ Solutions: Enhanced Science and Risk-Based Approach to Post-Approval Changes - Part 1
Embracing the Cloud While Ensuring Compliance
Quality Risk Management Basics as part of the Quality Management System
Science and Risk-Based Cleaning Validation. GMPs for the 21st Century.
Computer Software Assurance and an Evolving Risk-Based Quality Approach
Copyright © 2006-2021 Podbean.com