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

Tuesday, 18 November 2014
FDA Inspections - Managing inspection 483's, warning letters and responses to the FDA
Tuesday, 18 November 2014 08:30 - 17:00 (GMT)

Manchester Marriott Victoria and Albert Hotel
+44 (0) 161 832 1188
Water Street
M3 4JQ
United Kingdom

Map and Directions

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.

Course Tutors

  • James Pink
  • Yvonne Middlefell

The start and finish times given are approximate, please contact our office for further information.

Contact Details

Payment Instructions

  • Payment Methods

    By Bank Transfer — We are happy to accept payment directly into our bank account so long as:
    • the full amount of the invoice is received net of all local and UK bank charges within 30 days from date of invoice
    • the payment timescale quoted at the bottom of our invoices is strictly adhered to
    • a remittance slip giving clear details of our invoice number is received at this office to coincide with the payment being credited to our bank account

    Our bank details will be sent with the invoice.

    By Cheque — Payment should be made by sterling cheque drawn on a UK bank and payable to NSF Health Sciences Ltd. Please ensure that the full invoiced amount, net of all local and UK bank charges, is received within 30 days from date of invoice. 

    Please note that, in both cases, if any bank charges are deducted prior to receipt, this amount will be re-invoiced to yourselves.

    By Credit or Debit Card — Using Regonline Secure Payment facility.

    Payments — A VAT invoice (if applicable) will be provided (VAT Reg No. GB 927 3679 85). Settlement must be received at least 10 working days prior to the course start date. Cancellations within 25 working days of the course start date are subject to charges (see Cancellations section below). If a Purchase Order number is necessary to effect settlement of our invoice, please provide.

    Cancellations — Written cancellations with a full refund will be accepted up to 25 working days before the start date of the course. A fee of 50% will be payable for cancellations received between 10 and 25 working days before the start of the course. Full course fees will be charged for cancellations received within 10 working days of the course start date. Delegate substitutions may be made at any time up to the start of the course. Refunds will be made within 30 days of receiving the written cancellation by the same method that payment was made.

    Late Payment Clause

    We understand and will exercise our statutory right to claim interest at 2.5% above the prevailing Bank of England base rate under the Late Payment of Commercial Debts (Interest) Act 1998 if we are not paid according to our agreed credit terms.

    The programme and other information contained on this website are correct at the time of publishing and are published in good faith. We reserve the right to make any changes which may become necessary.

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