On-Site Inspections: They’re Back — But When, Where, and How

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

Please complete the form to access the webinar.



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 FDA audits and on-site inspection programs.


Now drug and device makers 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 inspection audits. This webinar will bring those two sets of expectations together to consider how post-pandemic audits may look. Regulatory compliance experts Sue SchnieppSeyed 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.


Webinar Takeaways:FDA inspection

  • Virtual Audit Practices
    1. Best practices for conducting virtual audits
  • On-site Audit Practices
    1. Best practices for conducting on-site audits
  • Models for Post-Pandemic Audits
    1. Frameworks for combining virtual audits and on-site audits
    2. Improving effectiveness and efficiency
    3. Maintaining oversight of suppliers, contract manufacturers, and test laboratories
    4. 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.


About RCA

Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

Our website uses cookies to give you the best possible experience.

By continuing to use this site, you agree to the use of cookies.