With the development and distribution of COVID-19 vaccines, the global health crisis is beginning to take a turn in some parts of the world. These changes have brought a strong desire to shift certain practices back to pre-pandemic norms — including a return to on-site inspections and audits.
Now drug and devicemakers are faced with the question of how to most effectively merge the best practices for conducting inspections before and during the COVID-19 crisis. It’s a task without a playbook but there are avenues to create one.
Regulatory agencies have developed guidance on conducting virtual audits and there have long been guidelines around on-site audits. This webinar will bring those two sets of expectations together to consider how post-pandemic audits may look. Regulatory compliance experts Sue Schniepp, Seyed Khorashahi and Steve Lynn will share insights on the likely structure of blended on-site and virtual inspections and audits. They will explore how these merged best practices will likely move forward and tips for developing an efficient, effective model.
- Virtual Audit Practices
- Best practices for conducting virtual audits
- On-site Audit Practices
- Best practices for conducting on-site audits
- Models for Post-Pandemic Audits
- Frameworks for combining virtual audits and on-site audits
- Improving effectiveness and efficiency
- Maintaining oversight of suppliers, contract manufacturers and test laboratories
- Understanding the operational changes needed to keep facilities safe during on-site inspections
The world will soon be returning to many pre-pandemic practices, including on-site audits and inspections. Get prepared for these changes and find the insights you need to merge your virtual practices with on-site interactions during this webinar.
Who Will Benefit:
- Pharmaceutical, biological and medical device companies
- Supplier and contract manufacturing companies
- Contract testing laboratories
- Audit managers
- Quality assurance and quality control leaders
- Operations directors
- Operations personnel
- Regulatory affairs leadership