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Validation of Analytical Methods with a QbD Approach nt's RAC recertification upon full completion.

GlobalCompliancePanel

Course

In Tukwila ()

£ 1,181.29 VAT inc.

*Indicative price

Original amount in USD:

$ 1,495

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Description

  • Type

    Seminar

  • Class hours

    9h

  • Duration

    2 Days

Preparation for Regulatory Inspections

Following the initial development, the steps further continues thru optimization and subsequently to Validation, leading to the understanding of Validation Parameters and their generic definitions. Guidance from EP, USP, ICH Q2 (R)1, AOAC etc. will be discussed. The presentation continually builds on from a conceptual level to practical applications leading to data handling, Data Integrity, Validation Protocol and other documentation, vis-a-vis Regulatory requirements. Discussions provide extensive guidance for preparing Methods Validation Protocols for the various stages of regulatory submissions, e.g. IND, NDA, ANDA, PAI, CMC etc. Various aspects of Laboratory Controls (CGMP), QC procedures, SOPs that cover calibration, standardization, Qualification and Validation, will be included, along with statistical tools, SQC, SPC for processing and monitoring of analytical data. Strategies for the development Stability indicating assays will be touched along with a discussion on Methods Transfer, Spec setting, QC Batch Release, Potency Assays etc.

About this course

An overview of global compliance issues, global harmonization initiatives, role of ICH, relevance of Validation activities & the Paradigm Shift
Quality Control and Quality Assurance in Analytical, R&D, QC, PD laboratories: General considerations, Quality Systems, QC procedures, QA oversight, Process Control Measure.
Perspectives of ICH, ISO Integration: ICH Q1 (Stability Studies), Q2 (Analytical Methods), Q3 (Impurities), Q7 (Pharma Process), Q9 (Risk Assessment), Q10 (Quality Systems), etc.
Measurement, Measurement Uncertainty, Measurement Resolution, Total Error, Bias
Analytical Measurement: Process Model & Risk Assessment (REMS) in Methods Dev.
A generic, science based outline of Methods Development & Validation [ab initio]
Perspectives of QbD, PAT directives: online measurements /offline and the Paradigm Shift.
Validation Parameters, their generic definitions and their practical applications.
Highlights of the guidelines derived from International Standards - ISO 17025, AOAC, WHO, GLP, GMP, EMEA, USP/EP/JP, etc.
Standardization/Qualification/Verification/Validation: the implicit continuum
The challenges in Methods Transfer, the premise of Co- Qualification.
Some case histories and applications for improvement of Validation characteristics
Data integrity and statistical evaluation of analytical data: SQC, control charts etc.
Methods Development and Optimization in HPLC, UV-VIS including assessment of Peak Purity, as examples of the most recent techniques widely used in analytical laboratories.
Phase Appropriate Validation & Regulatory submissions: IND/ ANDA/ NDA/ CMC.
Preparation for Regulatory Inspections from FDA, EMA, WHO, ANVISA, etc

Scientists
Managers
R&D Personnel
Quality Assurance / Quality Control Staff
Validation Managers
Validation Coordinators
Production and Process Development Personnel
Regulatory/Compliance Managers
Chemists
Technicians Study Directors(GLP)
Qualified Persons (EMEA)
Pharmaceutical Development
CRO Staff
CRO Managers
Accredited Laboratories in general, any one engaged with Test Methods.


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Reviews

Subjects

  • Risk Assessment
  • Risk
  • Personnel
  • Compliance
  • Quality Systems
  • Quality Assurance
  • Staff
  • Presentation
  • ISO 17025
  • Approach
  • Protocol

Teachers and trainers (1)

Shib Mookherjea

Shib Mookherjea

Senior Director, ValQual International

Course programme

Day 1 Schedule

Lecture 1:

  • Quality Systems, Paradigm Shift, Global Perspectives
  • QA/QC Validation, Laboratory Controls
(Sections I & II)

Lecture 2:

  • Risk Assessment, Strategy & Process Model
  • Measurement Resolution, Errors and
(Sections III & IV)

Lecture 3:

  • Rationale of Methods Development and Validation, A Generic Approach
(Section V)

Lecture 4:

  • Guidelines of Method Development, Optimization and Validation Approaches [ab initio]
  • Generic Definitions: Validation Parameters
(Sections VI & VII)
  • Q&A
Day 2 Schedule Review of Parameters, Axioms & General Practices

Lecture 1:

  • Validation Guidelines: ICH, USP, Eurachem, AOAC, ISO 17025
(Section VIII)

Lecture 2:

  • (CONT.) Validation Guidelines: ICH, USP, Eurachem, AOAC, ISO 17025
(Section VIII)

Lecture 3:

Class Breakout Discussion - Group Exercise

Lecture 4:

  • Regulatory & Data Requirements
  • Optimization and Validation in HPLC
(Sections IX & X)

See related categories

Validation of Analytical Methods with a QbD Approach nt's RAC recertification upon full completion.

£ 1,181.29 VAT inc.

*Indicative price

Original amount in USD:

$ 1,495

The best Medicine courses

See all

See all