SQA is sensitive to the educational needs of its members as we all contend with altered work environments and procedures during the COVID-19 pandemic. This page is dedicated to listing resources that may be helpful to QA professionals as they work under these conditions.
COVID-19 Meeting Sessions In September 2020, SQA held Virtual Meeting & Quality College. Multiple sessions addressed topics related to SARS-CoV-2 (COVID-19).
Remote Assessments - Management and Execution (P 35-01) South African National Accreditation System (sanas)
FAQs COVID-19 South African National Accreditation System (sanas)
Guidance on the Conduct of Clinical Trials in Relation to the COVID-19 Situation Health Sciences Authority (Singapore HSA)
Updated 14 July 2020: MHRA regulatory flexibilities resulting from coronavirus (COVID-19) Medicines and Healthcare products Regulatory Agency (UK MHRA)
Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic European Commission, EMA, HMA
Notice to Stakeholders: Questions and Answers On Regulatory Expectations For Medicinal Products For Human Use During The Covid-19 Pandemic European Commission, HMA, EMA
Guidance on remote GCP inspections during the COVID19 pandemic (18 May 2020) European Medicines Agency
Draft Guidance: Points to consider on implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials European Medicines Agency SQA Comments on this draft guidance, submitted 25 April 2020
Management of clinical studies in Italy during the COVID-19 emergency Italian Medicines Agency
Guidance about COVID-19 for sponsors, sites and researchers (pdf, 2 Apr 2020) Guidance about COVID-19 for sponsors, sites and researchers (website) NHS Health Research Authority (UK)
Managing clinical trials during Coronavirus (COVID-19) Medicines and Healthcare products Regulatory Agency (UK MHRA)
Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID-19) Medicines and Healthcare products Regulatory Agency (UK MHRA)
Press Announcements (including the COVID-19 Daily Roundup) U.S. Food and Drug Administration
Guidance 21 January 2021: Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency U.S. Food and Drug Administration
Coronavirus Treatment Acceleration Program (CTAP) U.S. Food and Drug Administration
Update 10 July 2020: FDA prepares for resumption of domestic inspections with new risk assessment system U.S. Food and Drug Administration
Recording pending, Webinar, 29 May 2020: Monograph reform is here! Learn what to expect and how to prepare. U.S. Food and Drug Administration RQAP Units Available
Guidance: Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic (updated 21 September 2020) Webinar Recording 30 Apr 2020: Conducting Clinical Trials During the COVID-19 Public Health Emergency Webinar Slides: Conducting Clinical Trials During the COVID-19 Public Health Emergency U.S. Food and Drug Administration
Guidance: Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency U.S. Food and Drug Administration
CDER | Coronavirus (COVID-19) | Drugs U.S. FDA Center for Drug Evaluation and Research
Contacts for Medical Devices During the COVID-19 Pandemic (Hotline closes after 17 July 2020) U.S. Food and Drug Administration
Guidance (revised June 2020): Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency Webinar Slides: Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing... U.S. Food and Drug Administration
Guidance, June 2020: Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing U.S. Food and Drug Administration
Guidance for Industry, August 2020: Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers U.S. Food and Drug Administration
Guidance for Industry, May 2020: Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency U.S. Food and Drug Administration
Guidance for Industry, May 2020: Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency U.S. Food and Drug Administration
Guidance for Institutional Review Boards and Clinical Investigators: Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency U.S. Food and Drug Administration
Guidance: Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency U.S. Food and Drug Administration
EPA Solicitation Clauses: Flexibilities Available to Organizations Impacted by COVID-19 U.S. Environmental Protection Agency
Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants U.S. Environmental Protection Agency
Coronavirus (COVID-19) information from EPA - Disinfecting; Drinking water & wastewater; Recycling & food management; etc. U.S. Environmental Protection Agency
Important notice regarding "hard copy" submissions to EPA U.S. Environmental Protection Agency
Coronavirus disease (COVID-19) Health Canada
Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors Health Canada
Considerations to Support Clinical Trial Monitoring Oversight During COVID-19 Association of Clinical Research Organizations (ACRO)
COVID-19 Updates UCLA Clinical and Translational Science Institute
Guidance: Conduct and Review of Studies to Support New Animal Drug Development during the COVID-19 Public Health Emergency U.S. Food and Drug Administration
Guidance: Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency U.S. Food and Drug Administration
Resources: Animal Health & Safety and the Coronavirus Disease 2019 U.S. Food and Drug Administration
Use of Cloth Face Coverings to Help Slow the Spread of COVID-19 U.S. Centers for Disease Control and Prevention (CDC)
Can Pharmacovigilance meet the COVID-19 Challenge? A checklist approach to PV Business Continuity Navitas Life Sciences - Shared by the SQA Pharmacovigilance Specialty Section (PVSS)
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Interactive panels on a series of hot topics, followed by Q&A
Purchase the recording to add it to your My Online Education library. (Please sign in.) SQA Members: $0.00 Non-members: $50.00
SQA Connect Lounge recordings are now part of the Webinar Recordings Library
Purchase the recording to add it to your My Online Education library. (Please sign in.) SQA Members: $0.00 Non-members: $25.00 to $50.00
Also browse our Webinar Recordings Library
COVID-related Recordings:
2014 AM: M-2-Remote Investigator Site Auditing (available only through the end of 2022)
2016 AM: H - e-Signatures and You - Are you compliant?
2017 AM: K-1 - Remote Auditing
2018 AM: Y-1 - Remote or Multisite Vendor Auditing
Timely Topic: Introduction to 21 CFR Part 11: Electronic Records; Electronic Signatures
E-Signatures in the time of COVID-19
Computer Validation & Information technology Compliance Specialty Section (CVIC-SS)