Prague, Czech Republic
Course No 15438
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Speakers from the Validation & Verification Expert Panel at United States Pharmacopeia (USP):
The validation of analytical procedures is a critical 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. This conference will address how USP's proposed vision for the development of a new general chapter aligns with the principles of US FDA and EU Annex 15 guidance on process validation and analytical quality by design. This covers design, development, qualification, transfer and verification.
Conference presentations, case studies and open discussions will help participants learn more about the lifecycle management of analytical procedures and provide a forum for discussing USP's new general chapter and Stimuli articles related to this topic. Participants will thus have the opportunity to give feedback and ask questions directly to USP's Expert Panel Members on how to move forward with the transition to and implementation of the lifecycle approach.
The meeting will also address topics such as:
a new calculation tool kit - General Chapter <1210> - to facilitate and simplify the statistical calculations required for validation,
establishing an analytical target profile as well as an analytical control strategy,
harmonization of nomenclature for development, qualification and verification of analytical procedures as part of a lifecycle concept.
The USP and the ECA Academy wish to actively involve analytical chemists, QC analysts, quality assurance associates & managers, R&D scientists, statisticians & managers as well as manufacturing scientists and managers, regulatory affairs specialists and contract laboratories in this critical area for analytical science.
Save 100,- Euro by booking until 30 May 2016.
Introduction to the ECA Foundation and Academy and the collaboration with USP
ECA introduction (Dr Christopher Burgess)
USP collaboration design and intent (Dr Horacio Pappa)
An Integrated Approach to Analytical Procedure Lifecycle; a USP perspective
This session will introduce the USP Validation and Verification Expert panel vision for the development of a new general chapter on analytical procedures over the life cycle which is consistent with the principles of FDA and EU Annex 15 guidance on process validation covering design, development, qualification, transfer and verification and aligned with the concepts of Analytical Quality by Design.
Moderator: Dr Christopher Burgess
Update from the Validation and Verification Expert Panel: Review of the revision process for USP General Chapters <1225>, <1224> and <1226> with an introduction to a new general chapter and the workshop (Greg Martin)
Analytical Target Profile and Measurement Uncertainty
Results and reportable values generated using analytical procedures provide the basis for key decisions regarding compliance with regulatory, compendial, and manufacturing limits. Decision Rules are applied for the acceptance or rejection of a product based on the measurement result, its uncertainty, and acceptance criteria, taking into account the acceptable level of the probability of making a wrong decision.
Moderator: Greg Martin
What is an ATP? (Dr Pauline McGregor)
Specifications, Measurement Uncertainty and Decision Rules (Jane Weitzel)
Q & A panel session
Stage 1: Application of AQbD principles in procedure lifecycle
During this session, examples of the use of AQbD tools and lifecycle approach for the validation of analytical procedures will be presented.
Moderator: Elizabeth Kovacs
Case study (Kimber Barnett)
Case study (Mark Argentine)
Establishing an Analytical Control Strategy
An Analytical Control Strategy is an essential procedure in ensuring that the data quality requirements defined in the ATP are realized throughout the lifecycle.
Moderator: Dr Horacio Pappa
What is a control strategy? (to be named)
Application of Quality Risk Management principles over the lifecycle (Elizabeth Kovacs)
Stage 2: Confirming the desired state in the routine analytical environment during procedure qualification and transfer
Confirmation of procedure performance and ‘fitness for purpose’ (PPQ) in the operational laboratory is an essential step before routine testing is undertaken.
Moderator: Kimber Barnett
Fitness for purpose of analytical instruments and systems; Data Integrity and Security confidence requirements over the Analytical Lifecycle (Dr Bob McDowall)
Experimental evidence of adequate Analytical Procedure Performance Qualification (Dr Joachim Ermer)
Replication Strategy (Dr Joachim Ermer)
Overview of statistical tools for Analytical Procedure Performance Qualification, General Chapter <1210> (Jane Weitzel)
Stage 3: Continued verification of performance of analytical procedures.
This session will discuss statistical tests and tools that apply to the verification of analytical procedures. Statistical tools for procedure validation, a proposed new general information chapter, will be one of the topics for discussion.
Moderator: Dr Joachim Ermer
Overview of trend analysis and process capability and Application of statistical tools for the continued verification of performance of analytical procedures
(Dr Christopher Burgess)
Current regulatory vision for Analytical Lifecycle
Moderator: to be named
FDA Presentation (Lucinda Buhse - invited)
EU Presentation (to be named)
Examples for pharmacopoeial procedures – MHRA
Transitioning to the new paradigm
This session provides the forum for an open discussion between speakers, expert panel members and participants. The plan is to brainstorm the way forward for the industry with regards to implementation of the three stages of the lifecycle approach to analytical procedures. All participants will have a SWOT form to complete during the Workshop (question cards and a SWOT form for all participants at registration). The objective is to generate a consolidated SWOT analysis (Strengths, Weaknesses, Opportunities and Threats) for each stage of the life cycle. The collated output will be captured and made available on the ECA web site post workshop.
Moderator: Dr Pauline McGregor
Introduction to SWOT analysis for each of the 3 phases of the lifecycle (Kimber Barnett)
Brainstorming and capturing outputs on flip charts