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Mitigate the risk of receiving FDA 483’s leading to Warning Letters – Your Guide to a Preventative Approach

Here’s why you should download this webinar …

Life Science companies – Reduce the stress of compliance audits and minimise the risks of receiving FDA 483’s & warning letters through utilising a preventative approach. This webinar will give you access to a panel of experts including Robert Lewis FDA consultant, all with one aim – to help Life Science companies reduce the risk of receiving 483’s and warning letters. It will also give you insight into how to handle these warnings with appropriate corrective action. As well as looking at what technology is available to help prevent these warnings.

  • Common inspection observations

  • Insight direct from the FDA

  • Improve Data Integrity

  • Reduce the risk of receiving 483’s

Panel of Expert Presenters:

  • Eileen Sullivan-Scully, LZ Lifescience, US Business Development

  • Siobhan Fleming, LZ Lifescience, EU Business Development

  • Christian Fortunel, LZ Lifescience, Vice President

  • Keith Bowen, LZ Lifescience, General Manager

Guest Speakers

Guest Speaker: Robert Lewis, FDA Consultant, IHL Consulting Group

Robert Lewis L

Robert has been a consultant to US FDA regulated industries since September 2000 when he founded IHL Consulting Group, Inc. During his ten years with the US Food and Drug Administration, Robert served as an Investigator/ Drug/Pharmaceutical Specialist and conducted numerous cGMP and NDA/ ANDA pre-approval inspections at major domestic and international pharmaceutical facilities.