I recently had the pleasure of hosting two distinguished guests during a live webinar to discuss the impact of Covid-19 on the life science industry. During this webinar, sponsored by Dot Compliance, we identified the challenges and suggested mitigation measures and recommendations on how to address current and future business continuity challenges as a result of the Covid-19 pandemic.
The first part of the webinar focused on the challenges the onset of Covid-19 posed on the life sciences industry. The combination of travel restrictions, stay-at-home directives and the general chaotic nature of the sudden changes to daily routines required readjustments on multiple levels, many requiring leveraging technological tools to support the reality of the new work landscape. We also discussed the significant impacts on the global supply chain which resulted in significant shortages of PPE, ventilators and many other raw materials and finished goods (where is my Lysol?).
During the panel discussion, our experts weighed-in on the impacts as they were witnessed on a personal level but also on a broader level. Amnon Eylath, a pharmaceutical veteran and Andre Butler, an FDA consultant shared insights from the pharmaceutical, biotech and medical device sectors.
Key takeaways from the panel discussion were:
Although there were dramatic changes to how companies operate, many were able to take the proper steps to ensure business continuity, especially if they were already ahead in their digital transformation journey and able to leverage systems that were in place.
The benefits of using an eQMS solution for continued collaboration, document management and remote training were discussed with an emphasis on pure cloud solutions as enabling tools to address the work-from-home and no-travel directives.
Remote auditing was noted as a viable method during travel restrictions and beyond for multiple use cases including onboarding new CRO's or CMO's.
EU-MDR has been postponed, however the panel didn't see this as a setback, but rather as a delay towards introduction of this critical piece of regulation.
How to address the supply chain issues. The team suggested a number of ideas and weighed in the pros and cons of FDA Emergency Use Authorizations and the ramifications of short-cutting approval processes.
The panel also suggested mitigation measures and how to “weather the storm” and comeback even stronger.
We wrapped up with a Q&A session that covered burning questions from attendees. Our experts continue to be available for any follow-up questions.
The webinar in its entirety is now available through this link.
Dot Compliance continues to lead the life science software industry in offering a 90-day free trial to the Dot Compliance Suite of Quality and Compliance Management applications for any life science company that wants to evaluate a state of the art Quality and Compliance Management solution that's ready to be used straight out-of-the-box.
For inquires please visit: https://www.dotcompliancesuite.com/contact-us