Date: Tuesday, April 25, 2017
Time: 11:00 PM EDT
Data Integrity has emerged as a global regulatory problem. Regulators around the world are finding laboratory and manufacturing operations data that has been falsified or manipulated to achieve more desirable results. The integrity of data generated by regulated pharmaceutical companies and laboratories matters most, because properly recorded information is the basis for manufacturers to assure product identity, strength, purity, and safety. Non-compliance found in the integrity of data leads to warning letters and a regulatory action from agencies.
In this webinar, we will focus on Quality Control laboratory data integrity.
Topics will include:
- Definition of data integrity
- Why is data integrity a hot topic now?
- International regulations and standards
- FDA Warning Letter examples
- Challenges noted by FDA
- FDA enforcement outcomes
- Case study example violations from FDA
- Contributing factors (behavior and management)
- The Way Forward
- Governance, Quality Culture, Ethics
David C. Peterson is UL's subject matter expert in the interrelated fields of organizational development, Good Manufacturing Practices (GMP based on regulations issued by the U.S. Food and Drug Administration), curriculum development and instructional design. As such, he offers additional resources to UL Compliance to Performance's (KE) development of knowledge solutions for FDA-regulated clients. He has authored over 20 online GMP/QSR courses for UL clients and has facilitated the implementation of GMP/Quality Training systems for numerous pharmaceutical and medical device clients.