Duration: 45-50 minutes

Date & Time: June 30, 2020 @ 8 AM PDT / 11 AM EDT / 8:30 PM IST

Level: Life Science Professionals (mid to Senior level)

Why you should attend?

There are two key reasons why you should attend this webinar.

First, we’re in the midst of a pandemic, unemployment is at an all-time low, companies are experiencing financial losses and, as a result of these circumstances along with the stress and pressure everyone is feeling, productivity is at a low. This may be impacting your company’s ability to perform in a compliant manner according to procedure. Although travel restrictions are imposed, including those of regulators, business will eventually resume, and everyone will go into catch-up mode. This includes inspectors, who know the impact this pandemic has on organizations and their ability to comply with regulation and their own procedures. Regulatory trends appear to show spikes after a catastrophe. This webinar will help attendees become aware of the spikes and be vigilant to avert negative regulatory consequence.

Second, regardless of a crisis, catastrophe, or pandemic, implementing a technology solution for electronic logbooks just makes sense. Not only is efficiency improved, higher levels of compliance can be realized, and more insight can be derived from analysis of the electronic data. Also, this is one step in paving the way into PHARMA 4.0, which can only be attained by going paperless. Finally, another benefit in deploying an electronic logbook solution is that elimination of paper also removes, or significantly reduces, the contamination footprint.

Areas covered:

  • Equipment cleaning and use log regulation (211.182)
  • Regulatory trends post crisis/pandemic
  • The cost to industry for FDA 483’s related to logbooks
  • Electronic logbook and monitoring technology solution
  • Advanced technologies available today
  • Technologies of the future

Key learning objectives:

  • Understand FDA’s equipment cleaning and use log regulation (211.182)
  • Analyze regulatory trends from 2010 to 2019
  • Learn how an electronic logbook solution can avoid FDA findings
  • Gain insight on how going paperless today paves the way to PHARMA 4.0
  • Glimpse into the future of hands-free and human-free validation

Who will benefit?

Professionals across:

  • Quality Assurance/ Quality Control
  • Product and Process Development
  • Validation
  • Manufacturing Operations
  • Engineering
  • Regulatory Affairs

Instructor Bio:

Steve Thompson has worked in the life science industry for over 20 years and has experience working for Fortune 50 and start-up pharma, biotech, and medical device companies. As Director of Industry Solutions for ValGenesis, Inc., he helps the life science customers realize the benefits of applied advanced technologies. He is knowledgeable of internal and domestic GxP regulations, was certified as a Parenteral Drug Association auditor and has audited hundreds of companies globally. He’s on the Editorial Advisory Board for the Institute of Validation Technology (IVT), faculty member for Knowledge Exchange Network (KENX), a published author and frequent speaker at conferences.
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