Mitigate the Risk of Receiving FDA 483 Observations, Leading to Warning Letters – Your Guide to a Preventative Approach

Clinical Trials, Life Sciences, Pharma Manufacturing & Supply Chain, Pharmaceutical, Pharmaceutical Regulation,
  • Tuesday, May 24, 2016

Why Attend this Webinar:

  • 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%
  • Access a live Q&A with a panel of FDA and MES experts


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.

This webinar will give 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.

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 gives you the perfect forum in which to do this.

In this webinar we ask the FDA:

  • What is an FDA 483 observation and warning letter?
  • What is the FDA typically looking for during an audit?
  • How likely is your company to receive a FDA 483 and what are the most common reasons why letters are issued?
  • What should companies do if they receive an FDA Form 483?
  • What are the top tips for responding to warning letters – with guidance on what to do and what not to do.
  • What can companies do to prevent receiving an FDA Form 483 or warning letter?

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 will then go 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.

Live Q & A on conclusion of the presentation. Any delegate who joins the webinar will have access to a free of charge Discovery Visit with an MES expert.


Eileen Sullivan-Scully, Senior Sales Executive

Eileen Sullivan-Scully is senior sales executive at LZ Lifescience, with responsibility for helping decision makers evaluate and implement automation system software to maximise efficiency, growth and value in manufacturing.

Combining experience in medical technology and clinical pathology with a passion for automated solutions, Eileen is able to build strong partnerships with developing companies in the life sciences space. She is passionate about helping companies to effectively utilise cost affordable manufacturing execution system (MES) software.

Message Presenter

Christian Fortunel, Vice President

Christian Fortunel is vice president at LZ Lifescience Inc. (USA). He is responsible for operations management and the successful financial running of the US business, as well as bringing a wealth of manufacturing execution system (MES) solution deployment expertise to his role.

With an MSc in computer science, Christian began his career as a software engineer at Columbia University. Since then he has progressed to executive level positions within the MES industry.

Christian has over 20 years’ experience developing, managing and deploying MES solutions, having worked with many of the top 30 Pharmaceutical and biotechnology companies across the world to manage large scale MES implementations.

He uses his strong technical, business and management experience to successfully lead software development teams, build business units and advise executives on operational issues, software selection, risk management and process improvements.

Message Presenter

Siobhan Fleming, Business Development Manager

Siobhan Fleming is business development manager at LZ Lifescience. Operating primarily in mainland Europe and Ireland, Siobhan is responsible for meeting market demand for the company’s manufacturing execution system (MES) technology, building relationships and supporting customers in the life sciences industry.

Siobhan has worked in the automation and life sciences industries in a variety of roles and has strong knowledge of the full software lifecycle in the life sciences manufacturing environment. She is passionate about delivering affordable MES options to the life sciences industry.

Having worked for a number of leading providers of manufacturing software systems, Siobhan has a background in compliant software solutions, automation system integration, computer system validation (CSV), document management and enterprise resource planning (ERP) software.

Siobhan holds a Masters in Technology Management from University College Cork, a Graduate Diploma in Technical Communication from the University of Limerick and a Diploma in Marketing Strategy from the Irish Management Institute.

Message Presenter

Keith Bowen, General Manager

Keith Bowen is general manager at LZ Lifescience, with responsibility for sales, program management and manufacturing execution system (MES) solution design.

He has over 18 years’ experience in the life sciences industry, with knowledge and experience in developing, implementing and supporting MES and automation projects, having worked with many of the top 10 Pharmaceutical, biotechnology and medical device companies.

Keith has a BEng in Chemical Engineering and is a certified ITIL practitioner, specialising in IT service management. He is passionate about increasing the accessibility of affordable, web-based MES solutions to generate measureable cost and time savings to the whole of the life science industry.

Message Presenter

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.

Message Presenter

Who Should Attend?

Senior professionals from pharmaceutical, biotechnology and medical device companies involved in:

  • Clinical Research
  • Clinical Operations
  • Quality Assurance
  • Site Management
  • Supply Chain

Xtalks Partner

LZ Lifescience

LZ Lifescience delivers Manufacturing Execution Systems (MES) designed specifically to meet the needs of life science companies to improve manufacturing performance by over 25%. Our software Shopfloor-Online ™Lifescience Edition ensures that customers maintain a competitive advantage, through rapid implementation and manufacturing gains.

Our core functionality, which includes Electronic Batch/Device History Records, Weigh & Dispense & Equipment Management, eliminates paper in the plant, improves compliance and increases performance. It enables managers to analyse production and quality information in real-time, and helps reduce process and documentation errors, resulting in ‘Right First Time’ manufacturing practices whilst facilitating faster product release.

Shopfloor-Online™ Lifescience Edition delivers the following benefits to medical device companies:

Replaces paper records (Device History Records & logbooks) with electronic reporting
Uses workflow to eliminate human errors and incomplete data
Provides real-time visibility of production information
Enables processing of quality issues while production is taking place
Supports ‘review by exception’, where deviations only need to be reviewed
Automatically determines environmental issues
Collects downtime information to determine overall equipment effectiveness (OEE)
Delivers performance improvements of over 25% with a 12-month return on investment
With a network of offices in Ireland, UK, Belgium, Germany, USA and Asia, LZ Lifescience can rapidly support your business, help you increase competitiveness and lock in productivity gains for the long term.

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