*Free Session* COVID-19 Conference Trailer: Managing compliance outcomes in the virtual world
Expired

  • Eastern Standard Time: October 28, 2020
    1:00 pm - 2:00 pm

Location

Ontario, Canada
M QA QC

Certification Areas

Objective:

Compliance management processes have changed considerably, following the events and impacts of the SARS-2/COVID-19 pandemic. This webinar examines the impacts on quality system management caused by several factors, including changes to regulations, inspections, and audit processes, the workforce and working environment, and the reliance on virtual and electronic processes to support quality unit activities.

This free webinar is a part of the PSG COVID-19 conference trailer series. For more details of the COVID-19 conference, please click here.

 

Outline:

Necessity: The virtual compliance program

– No boots on the ground – Health Canada and U.S. F.D.A. inspections

– Trust, and verify? Perspectives on our obligations to keep patients and consumers safe

Regulatory landscape:

– Virtual Health Canada inspections and inspector powers

– Planned CUSMA and Health Canada guidance changes

– COVID-19 related regulatory guidance impacts

– GMP evidence audit program changes

Virtual compliance program tools:

– Virtual supplier quality audits and impact on vendor certification

– Virtual regulatory audits, preparation, and auditing

– Virtual training – QCA, the Q&C internal training experience.

Team Behavior:

– Engaging your quality team and connecting them

– Communication themes

– Electronic system adoption and process changes

What does this all mean?

– The only constant is change

– Managing electronically and virtually

– Evolving your Quality Management System

 

Speaker:  Aaron Clarke

Pharmaceutical Quality Management Systems are continuously refined to ensure that patient risk remains as low as possible. In his role at Q&C, Aaron Clarke is responsible for identifying industry trends and applying his extensive pharmaceutical quality leadership experience to establish and maintain practical, risk-based quality systems effectively and efficiently. This year, 2020, has provided a massive challenge with COVID-19 considerations and limitations.  On-site, quality consulting guidance and support has simply not been possible for most organizations. Mr. Clarke has used his knowledge of electronic systems, data integrity, validation, quality structures, evolving regulations, and training delivery to develop and implement effective solutions. These include remote and virtual audits as an alternative to on-site verification. This approach is quickly gaining momentum with Health Canada and other regulatory bodies worldwide.

Registration Deadline: 26 Oct 2020



Free Ticket: $0.00 Sold Out