Overview
A Comprehensive Review of the Latest MHRA Data Integrity Definitions and Guidance Including the FDA’s Most Recent Guidance.
Learning Objective
- Understand MHRA GMP data integrity definitions and guidance
- Review FDA data integrity guidance and principles
- Apply Quality Risk Management to identify vulnerabilities
- Recognize tell-tale signs of data integrity issues
- Differentiate intentional vs unintentional failures
- Develop remediation plans to reduce risks
- Learn how regulatory agencies detect issues
- Integrate FDA and MHRA approaches into compliance programs
Regulations Covered
- EMEA Eudralex Volumes 1, 2, 3, 4, 9 (EU)
- US CFR 21 Parts 210, 211, and 600 series
- MHRA GMP Data Integrity Guidance (2015, 2016, 2018)
- FDA Data Integrity and Compliance with cGMP Guidance (2016)
- EMA, WHO, and PIC/S guidance (2016)
- ICH Q9 Quality Risk Management
Webinar Outline and Timing
10:15 AM
Log in period
10:30 AM
Introduction
10:40 AM
What is data integrity? Impact of issues; Where failures happen; How to detect them; Intentional vs unintentional failures
11:30 AM
10 minute break
11:40 AM
Root cause analysis; Repairing failures; MHRA guidance; FDA approach; Warning letters; Prevention strategies; Conclusions
12:30 PM
Live Q and A and discussion
* All times are Eastern Time (New York)
Included with Registration
- A copy of the presentation slides
- Certificate of training for records
Who Will Benefit
- Quality Assurance & Quality Control personnel
- Supply Chain & Logistics Managers
- Regulatory Affairs Professionals
- Process Development Scientists
- IT and Senior Management
- Engineering staff and management
- Project Managers working in CMC
Faculty Carolyn Troiano
Award winning FDA Compliance Expert for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity
My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.
My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.
