Chapter 1 - Five Most Significant Impacts of COVID-19 on Data Integrity
What are the most significant impacts of COVID-19 on how pharmaceutical and medical device manufacturers implement their overall operations, secure their supply chain and conduct clinical trials? What innovative business practices will remain in the “new normal” after COVID-19? What is the impact on data integrity for regulatory, quality, compliance and data integrity specialists going forward?
1. The impacts of COVID-19 on operations and supply chain management
2. Conducting clinical trials during the pandemic
3. Data practices that may become the “new normal”
Chapter 2 - FDA’s Regulatory Stance
What new guidance issued during COVID-19 has most affected data integrity and impacted pharmaceutical, medical device regulatory and clinical trials professionals? Are these sets of guidance likely to still be in force in the post-COVID-19 era? What are the most problematic compliance issues as we look ahead to 2021?
1. Guidance that most affects data integrity
2. Regulations that may last beyond the pandemic
3. Possible compliance issues in 2021
Chapter 3 - Virtual Inspections & Audits
How has COVID-19 changed the way the pharmaceutical and medical device industry approach inspections and audits? Who’s doing virtual inspections and audits? What are the major challenges and pitfalls when considering virtual inspections and audits? What best practices can companies deploy to ensure virtual inspections and audits are acceptable and compliant?
1. General changes in inspection and audit practices
2. Virtual inspections and audits, including challenges and best practices
Who Will Benefit
· Pharmaceutical and device manufacturing teams
· CROs and clinical trial sponsors
· Data integrity consultants
· Regulatory, quality, and compliance specialists
· Clinical trial developers
· Clinical study data experts
· Vice presidents of strategic planning
· Medical product attorneys
· Drug and device consultants
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Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.