Process Validation – Lifecycle Approach

מרצה: Mr. Igor Gorsky

תאריך: 21, 22 ספטמבר 2016
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות: 9:00 - 17:00
עלות: 4,300 ש"ח + מע"מ
נקודות זכות: 0
מק''ט: 16951
שפת הקורס: אנגלית
על הקורס

The FDA’s revised Process Validation guidance, as well as subsequent revised EMA Annex 11, PIC/S and WHO Validation guidances represent the Food and Drug Administration’s (FDA’s) and most of the world current thinking on this topic.

This course shall illustrate the general principles and approaches that world regulatory bodies as well as industry experts consider appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in these guidances as drugs or products.

This course incorporates principles and approaches that all manufacturers can use to validate manufacturing processes. In addition, this course shall show how international guidances align process validation activities with a product lifecycle concept and with existing international guidances, including the International Conference on Harmonisation (ICH) guidances for industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.

The course uses case studies and interactive exercises to illustrate application of guidances. Particular attention is given to risk and knowledge management, use of statistics and introduction of process analytical technology as enablers for implementation of process validation activities.

קהל היעד
  • Process Development
  • Quality Assurance
  • Quality Control
  • Validation
  • Production/Operations
  • Engineering
  • Regulatory Affairs
This course applies to the following:
  • Pharmaceuticals
  • Biotechnology 
  • Medical Devices 
  • Biologics 
  • Stem Cells 
התועלת שתופק
  • Learning fundamentals of risk based lifecycle approach to process validation, including in-depth evaluation of all three stages of this pivotal activity.
  • Help pharmaceutical and biopharmaceutical firms’ personnel understand how to approach Process Validation activities by performing interactive exercises and solving case studies.
  • Risk and knowledge management and statistical techniques and analysis activities, as well as use of instrumentation, detection and PAT solutions to sampling and testing will be discussed to help in learning best approaches to risk based lifecycle validation solutions.
  • A special benefit to attendees would be review of strategies for legacy products.  

Key Learning Objectives

  • FDA’s Reasons for Process Validation Guidance Revision
  • Risk Management for Process Validation
  • Quality by Design
  • Design of Experiments
  • Stage 1 Process Development
  • Stage 2a Equipment Qualification
  • Stage 2b Process Performance Qualification
  • Stage 3a Continued Process Verification (Initial)
  • Stage 3b Continued Process Verification (On-going)
  • Enhanced Sampling
  • Number of Batches to be Produced for PPQ
  • Legacy Products
  • Process Validation Statistics
  • Process Validation and Regulatory Filing
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס

Day 1
Part 1 – Introduction

  • Review of previous PV guidance
  • FDA’s 5 main reasons for Process Validation Guidance Revision
  • Update of new developments, regulatory trends/citations
    • Legacy process with changes
    • New process proactive
    • Remediation issue – failure with changes
    • Sterile Products Unit Operations
    • Solid Dosage Unit Operations

Part 2 – Stage 1 Process Design

  • Master planning, organization and schedule planning
  • Risk/impact assessment
  • Process/system design
  • Identify Critical Quality Attributes and Critical Process Parameters
  • Key vs. Critical Process Parameters
  • Design of Experiments
  • Developing control strategies

Part 3 – Interactive session

  • Perform risk assessment
    • Determine process design using the principles and methods discussed for group process related example
    • Determine CPQ and Process Parameters
    • Process Control Strategy
  • Reporting and tech transfer strategy

Part 4 – Stage 2 – Process Qualification

  • Equipment qualification
  • Developing test functions and acceptance criteria, protocol development and review.  What’s important and relevant to Process Validation
  • Applied statistical tools, sampling, analysis and interpretation of results
  • Deviations, discrepancies (events during validation and investigations

Part 5 – Breakout - Session 2

  • Determine Test Plan for Equipment Qualification
  • Determine Test Plan and Acceptance Criteria for PPQ and report back

Day 2
Part 6 – Stage 3 – Continued Process Verification

  • Determining when CPV starts
  • Legacy systems vs. new systems
  • Legacy products case studies
  • CPV strategy, enhanced sampling
  • Maintenance of Validation and change Control, and Periodic Assessment
  • Problem solving and investigation

Part 7 – Break out session 3

  • Develop strategies for CPV
  • Work through a problem we give them and write a final power point report

Part 8 – Final Reporting

  • Final Reporting
  • Inspection Readiness
  • Additional Case studies
  • Questions and Answers
אודות המרצה

Mr. Igor Gorsky

Mr. Igor Gorsky has over 30 years of experience leading validation, technology transfer, quality assurance and manufacturing functions in a wide range of pharmaceutical and biotechnology generic and brand firms. Prior to ConcordiaValsource, .
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