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A Risk Based Strategy for the Development & Validation of Analytical Methods with a QbD Approach

Held in conjunction with QbD in Pharma Development World Congress 2017

18 Apr 2017 - 19 Apr 2017, at 9:00 am to 5:00 pm in Hyderabad


This Short Course introduces the schematics of Methods Development and Validation with a grass roots, conceptual standpoint, based on scientific rationale and a Method by Design approach, a concept akin to QbD. The presentation will begin with the aim to simplify analytical methods down their basic elements. The goal is to lead the audience to the understanding, of the analytical method, with a focus on Quality, right from the inception. At the outset, it implores the analytical chemist to grasp an Analytical Method as a process of Measurement. They are then lead to understand the concepts of Measurement errors, Measurement Uncertainty, Measurement Resolution etc. which are inherent to any physicochemical Measurement process and the outcome. The extent of such errors needs to be explored, mitigated, minimized and established for the specific method, as it is being developed. Thus, this training course presents a goal oriented Method Development with a generic, iterative, sequential and modular approach, leading eventually to the establishment of the Validation Parameters at the Validation stage.

Following the initial development, the steps further continues through 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 in the discussions, along with statistical tools, SQC, SPC for processing and monitoring of analytical data. The larger issue of Data Integrity and strategies for the development Stability indicating assays will be touched upon along with a discussion on Methods Transfer, Spec setting, QC Batch Release, Potency Assays etc.

General Theme:

“For various Analytical and Test methods a goal oriented pathway with proper Design prior to Development activities will help build Quality into the method from the inception (QbD) and Validation helps to demonstrate that the desired Method is Fit For The Purpose . A Risk based strategy is needed to Develop and apply them for their intended purpose during the entire Life Cycle of such methods”.

Workshop/ Case Studies Session (2nd Day Lunch time):

This Short Course is highly interactive and participative. Attendees are encouraged to interact and be prepared to bring their own examples of difficult Analytical Development and Validation issues if any, which will be discussed during the second day. A class Breakout session (for about 2 hours) is normally included, wherein the attendees will be expected to participate in solving assignments of group exercise. This workshop style session requires and demonstrates that the attendees do apply the practical applications of the concepts learnt during the two days. Over the years, thousands of attendees have enjoyed and appreciated this Breakout session immensely.

Who Should Attend:

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 and in general, any laboratory personnel who is engaged with Test Methods.

Benefits of Attending:

  • Increase your knowledge of conformity assessment, QC/QA in the Regulated Laboratory
  • Increase your knowledge about cGMP/EMEA/ICH/WHO compliance issues.
  • Consult with a knowledgeable instructor about your current technical problems and preparation and requirements for submission of regulatory packages (NDA, ANDA, IND, MMA and others for various Regulatory Agencies)
  • Learn about a sequential, iterative and modular pathway for analytical Method Development and Validation on an ab initio, (Qbd ) approach , while assessing and Mitigating Risks.
  • Be exposed to the latest international requirements and guidelines: ICH Q2 R (1), ISO 17025 OECD, AOAC,WHO & FDA guidelines for Analytical Validation procedures.
  • Learn about the choice of general Validation and Qualification requirements for analytical instruments such as HPLC, TOC, CE, LC-MS, AA, UC/VIS, Dissolution.
Key Topics to be Covered:
  • 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 Development.
  • A generic, science based outline of Methods Development & Validation [ab initio].
  • 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.

Shib Mookherjea

Shib Mookherjea, Senior Director, ValQual International