Training Course Syllabus:
Course Description This Course is highly interactive and participative. Attendees are encouraged to interact and be prepared to bring examples of Analytical Development and Validation issues, 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 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. Learning Objectives: Increase your knowledge of conformity assessment, QC/QA in the pharmaceutical 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 FDA & OECD)
Learn a generic approach for developing an analytical method and optimizing it
Become acquainted with practical approaches for validating new analytical procedures
Familiarize yourself with methods development and optimization in HPLC
Be exposed to the latest international requirements and guidelines: ICH, ISO 17025, OECD, & FDA guidelines for analytical validation
Learn about the FDA’s new initiatives in systems-based inspection and risk-based assessment
Understand the training and supervision requirements of chemists and technicians and other lab personnel for GLP
Receive helpful hints to help prepare you for a visit from an auditor’s perspective
Learn about general validation and qualification requirements for analytical instruments such as HPLC, TOC, CE, LC-MS, AA, UC/VIS, dissolution and other emerging techniques Areas 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)
A generic, science based outline of Methods Development & Validation [ab initio]
Perspectives of QbD, PAT directives: online measurements vs. offline
Validation parameters, their generic definitions and their practical applications to various methods
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
A generic approach to Analytical Method Optimization during development
Some case histories and applications for improvement of Validation characteristics
Data integrity and statistical evaluation of analytical data: SQC, control charts
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 DAY 01(8:30 AM - 4:30 PM) 8:30 AM - 8:59 AM: Registration, Meet & Greet.
9:00 AM - 10:30 AM:
Section I - Quality Systems, Paradigm Shift, Global Perspectives
Section II - QA/QC Validation, Laboratory Controls
In these sessions we will cover the general info, FDA Directives, Harmonization and CFR Clauses Requiring Methods Validation. PAT Platform, Basics of QC/QA, MVP, REMS
10:30 AM - 10:45 AM: Break
10:45 AM - 12:15 PM:
Section III - Risk Assessment, Strategy & Process Model
Section IV - Measurement Resolution, Errors and Uncertainty
During these sessions we will cover Identifying and Mitigating Risks, Integration with QS.
12:15 PM - 1:00 PM: Lunch
1:00 PM - 2:30 PM:
Section V - Rationale of Methods Development and Validation, A Generic Approach
During this session we will cover the Pathway of a Generic, Sequential and Modular Approach, Goal Oriented Methods Development, Stages in Opt/Validation
2:30 PM - 4:00 PM:
Section VI - Guidelines of Method Development, Optimization and Validation Approaches.
Section VII - Generic Definitions: Validation Parameters
During this session we will cover Understanding Validation Parameters as Method CQA’s, Initial Exploration: A Road Map
4:00 PM - 4:30 PM: Q&A Session DAY 02(8:30 AM - 4:30 PM) 9:00 AM - 10:30 AM: Review of Parameters, Axioms & General Practices
Section VIII - Validation Guidelines: ICH, USP, Eurachem, AOAC, ISO 17025
10:30 AM - 10:45 AM: Break
10:45 AM - 12:00 Noon
Cont. of session VIII
This session will cover Guidelines from US FDA, EMEA, WHO, USP, JP etc. on Methods Validation
12:05 PM - 1:00 PM: Lunch
1:00 PM - 3:15 PM: Class Breakout Discussion - Group Exercise
The attendees solve assigned Analytical Development problems and come up with Validation Protocol using the concepts learned
3:15 PM - 4:00 PM:
Section IX - Regulatory & Data Requirements
In this section we will discuss about Examples of FDA Enforcement Actions and other Reg. concerns
4:00 PM - 4:30 PM: Q&A Feedback |
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