OOS Investigations in a GMP Environment 17 & 18 October 2016, London

What is an OOS result?

A result that falls outside established acceptance criteria which have been established in official compendia and /or company documentation.

Approved documents such as:

  • Certificates of analysis (C of A’s)
  • Specifications
  • Drug Master Files (DMFs)
  • Official compendia
  • Filed applications, approved marketing submissions
  • Stability protocol

This course is based on the FDA guideline ‘Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production’, October 2006

 

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QbD and Lifecycle Management for Analytical Methods

The validation of analytical procedures is an important  part of any process for ensuring drug quality. Since 2014, USP’s Validation and Verification Expert Panel has been considering how the modern concept of lifecycle model process validation can be applied to analytical procedures.

QbD and Lifecycle Management for Analytical Methods 13 & 14 October 2016 London – Book your place now.

The expert speaker for this course is Dr Pauline McGregor.

Pauline is a member of the Validation & Verification Expert Panel at USP.  Pauline McGregor has a pharmaceutical consultant for many years. She has over twenty five years’ experience in the Pharmaceutical industry and holds a Ph.D in chemistry. She is an expert in quality systems and procedures, GMP regulations and analytical chemistry. Pauline has been involved with and has had a passionate interest in the evolution of method development, validation, transfer and verification of analytical methods and has been actively involved in authoring a paper and presenting short talks and training courses on the application of QbD to analytical methods. Pauline is currently a member of the Royal Society of Chemistry, UK and is listed on the RSC Directory of Consultants.