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Virtual operations have become a necessity in Pharma due to travel restrictions, quarantines, social distancing and absences imposed due to the Covid-19 pandemic. Working from home became the norm and in-person activities such as audits were no longer allowed. Health Authorities have delayed on-site inspections which has delayed some approvals.

Regulatory requirements and regulations have not changed. Regulatory oversite and approvals are based on documentation, transparency, historical performance and risk. Regulatory excellence and success rely on evidence and proof. Data must be accurate and data integrity ensured. Quality Assurance must review and approve quality-related documents and data. Data must be available in a readily-retrievable manner throughout the retention period. The requirements have not changed but approaches to meeting the requirements have changed.

Join our live webinar to learn more on:

    What the regulatory requirements are

    The key aspects of virtual operations
    What has changed within regulatory operations


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Mark R. TePaske, Ph.D.

Senior Director of Global Regulatory Affairs, Quality and Compliance


Dr. TePaske currently serves as the Senior Director of Global Regulatory Affairs, Quality and Compliance at Cambrex Corporation where he has twenty-eight years of experience working in a cGMP environment. His areas of professional experience include Quality Assurance, Quality Control and Analytical Development. Mark recently provided hands-on QA oversight over the successful implementation and validation of ERP systems SAP and TrackWise © across the Cambrex Corporation manufacturing sites. Dr. TePaske, and team members, were awarded the Cambrex Corporation Presidents Quality Award in 1997 and 2010. Mark has also been nominated for the Cambrex Corporation John F. White Technical Achievement Award four times and the Cambrex Corporation President's Quality Achievement Award once.

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Maire Gerrard

Custom Content Writer

Informa Pharma Intelligence

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