The Regulatory Aspects of Validation and Implementation of a New Technology

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The agenda proposal aside has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

Agenda Proposal

08.30 - 09.00 Welcome & Introduction
09.00 - 10.00 Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). What is the difference, which to apply to a validation study and when.
10.00 - 10.45 Validation Guidelines:
  • Pharmacopoeias
  • ICH
  • Regulatory agencies FDA/MHRA
  • Industry e.g. PDA Technical report 33.
10.45 - 11.15 Coffee
11.15 - 12.15 What are the Requirements for an Internal Validation Study?
  • Elements of the validation:
  • Design qualification (DQ) definition/documentation
  • Installation qualification (IQ) definition/assistance
  • Responsibility is very often delegated to the supplier for DQ and IQ
  • Operational Qualification (OQ) definition/proof of principle
  • Performance Qualification (PQ) definition/how far to go
12.15 - 13.00
  • The validation protocol
  • Re-sourcing and execution of the validation study
  • The Validation report
  • SOP's and documentation
  • Regulatory submissions
  • Implementation and change control
13.00 - 14.00 Lunch
14.00 - 15.00 Audits
  • Regulatory audits FDA, 3 types of audit
  • MHRA and other European agencies
  • Customer audits
  • What are the auditors looking for?
  • How are audits structured?
15.00 - 15.30 Tea
15.30 - 16.15 Data security, accessibility and ease of tracking and trending GMP Failures and Warning Letters
16.15 - 16.45 Recent experiences with regulator inspections on the Validation and implementation of MicroSeq. FDA 483 citation MHRA comments.
16.45 - 17.00 Final Discussion Round


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