FDA Inspections - Managing inspection 483's, warning letters and responses to the FDA.

About this course

FDA inspections are incredibly stressful events particularly for the less experienced medical device manufacturer.

Understanding how a deficiency is being identified by the inspector and the expected responses and actions by the manufacturer from the Agency is by in large the most critical aspect of any inspection process. Senior Management and Quality Responsibilities within Europe are more used to European Notified Body Non-conformities and thus underestimate the expectations by the US Food and Drug Administration. In particular through…

1) too fast a response,
2) a lack of understanding of the “root-cause” and systemic issues and…
3) creating a negative impression of the company by the agency.

This 1 day course will help you to understand the bigger picture relating to the FDA inspection programme, the formulation of deficiencies and the expectations by the agency on how you should respond and what actions you should be taking.

Course outline

• About the FDA inspection process
• How the FDA inspector formulates a case / identifies a non-conformity
• The Form 483 – How it is written, issued and the expected responses
• Warning Letter – Why it is written, how it is written, issued and expected responses
• Internal Communication when receiving a 483 / Warning Letters
• The differences between EU Notified Body Non-Conformities and FDA deficiencies
• Hints and tips to avoid further action and manage the process effectively.

Venue

Manchester Marriott Victoria and Albert Hotel, Manchester, UK

The Manchester Marriott Victoria & Albert Hotel stands on the banks of the River Irwell, near the city centre but convenient for Manchester Airport (19km), the city’s Piccadilly rail station (3km) and the UK’s motorway networks.

Recently lovingly restored, this Grade II listed building bears many modern features. The hotel has its own car park and a few minutes’ walk takes you to the city’s main shopping and eating district.

Hotel Accommodation

• Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
• To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
• This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
• If you need any help or guidance with the accommodation booking process, please contact our course administration team.
• Your account with the hotel should be settled at check-out.
• Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.

Venue Address and Contact Details

Manchester Marriott Victoria & Albert Hotel
Water Street
Manchester
M3 4JQ
England

Tel: +44 (0) 161 832 1188
Fax: +44 (0) 161 834 2484

www.marriott.co.uk

Tutors

The tutors for this course are as follows:

• 

  James Pink
  Medical Devices, Vice President
  

  • [email protected]
  • +44 (0) 1143 600868
• 

  Yvonne Middlefell
  Medical Devices, Executive Director Regulatory Affairs
  

  • [email protected]
  • +44 (0) 1143 600868

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