Mitigate the risk of receiving FDA 483’s leading to warning letters – A preventative approach: Webinar Available
Life Science companies can reduce the stress of compliance audits and minimise the risk of receiving FDA 483’s through utilising a more informed and preventative approach to operations management.
FDA Update 2016 / 2017
The FDA is responsible for issuing 483’s to life science companies if during audits they find any violations, production or quality issues that raise concern to the health or safety of the general public. We are hearing in the press that more and more Life Science Companies are being issued with FDA 483’s sometimes with catastrophic outcomes. When it comes to avoiding these letters, an understanding of industry requirements, using appropriate tools and preparing for audits is key.
Insight direct from an FDA consultant
The best way to stay up to date with FDA enforcement activity is to attend events and webinars where FDA consultants are present and get the opportunity to speak directly to them about the latest in Regulatory Affairs and Quality Assurance.
This webinar recording gives you access to a panel of experts including FDA consultant Robert Lewis, IHL Consulting, Atlanta, all with one aim – to help life science companies reduce the risk of getting FDA 483 in 2016 and beyond.
- Hear common inspection observations from the FDA and key reasons for Form 483 and warning letters
- Learn how best to handle FDA warnings with the appropriate corrective response
- Understand how Manufacturing Execution Systems (MES) can work as a preventative approach
- Gain tips and techniques to improve manufacturing performance by over 25%
Corrective and Preventative Action
Archaic systems can be a leading cause of contamination and data integrity issues, and so, now more than ever, organisations need to embrace technology as a preventative approach to these issues.
This webinar goes on to cover how life science companies can proactively use the latest technology advancement for corrective and preventative actions (CAPA) to help avoid receiving warning – such as data integrity issues, human error and workflow issues.
Introducing Electronic Batch Records / Device History Records
Find out how batch records can prevent incomplete data and contamination issue and discover how Shopfloor-Online™ Lifescience Edition, a robust and reliable MES solution designed for life science companies, can improve manufacturing performance and drive operational excellence.
About the Guest Speaker:
Robert Lewis, FDA Consultant, IHL Consulting Group
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. He was also co-leader of the Atlanta District Drug Tea and the Assistant ANDA / NDA pre- approval Program Manager. Robert now provides regulatory advice to a diverse array of clients, including specialized consultation at the executive and leadership level. Robert has been a frequent speaker at industry conferences and currently oversees all IHL consulting operations. He holds a Bachelor of Science Degree in Applied Biology from Georgia Tech.