ISPE Official course: Practical Implementation of Process Validation Lifecycle Approach - Updated!

Date

18th - 19th July 2024

Venue

Ambassador Hotel, Bangkok, Thailand

Details

ISPE Process Validation Training Course

*All participants of this PV Training Program are entitled to complimentary admission to the ISPE Thailand AGM 2024 Conference on 17th July 2024.

**For pharmacists who attend this course will receive 11.5 CPE accredits.

Overview

Lifecycle Process Validation (PV) reGuidance Documents ISPE PQLI Guide Part 2mains one of the most important and commonly misunderstood topics in the pharmaceutical industry.  How many lots should I make?  Are we taking enough samples?  Do we need to use statistics in our protocols?  The real question may be: am I even focusing on the right questions? 
Course participants will focus on the practical application of the lifecycle approach to all stages of PV to gain valuable knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry. 


What You Will Learn

  • Course participants will focus on the practical application of the lifecycle approach to all stages of PV to:
  • Understand the importance of product and process understanding and patient requirements.
  • Know how to apply QRM tools for PV.
  • Recognize opportunities to leverage process design information to establish a process validation strategy and a process performance and product quality monitoring program.
  • Understand the challenges to the application of an entirely science- and risk-based approach.
  • Understand a variety of approaches to applying specific expectations of the lifecycle approach to PV including number of sampling, acceptance criteria and determining the number of batches for PPQ/PV.
  • Understand the differences in expectations among various major world markets.
  • Learn various approaches for deciding which attributes and parameters should be evaluated at a heightened level during PV stage 3.
  • Understand new expectations for routine process monitoring.
  • Understand the process validation lifecycle and the importance of maintaining an effective pharmaceutical quality system.
  • Apply process performance and product quality monitoring system elements to identify opportunities for continual improvement.
  • Minimize chance of validation failures by learning about adequate preparation in process understanding and ancillary systems.
  • Acquire tools to prepare for a smooth validation execution.
  • Understand implications of validation deviations.
  • Maximize and be able to apply your understanding of ICH terminology including the principles of a science- and risk-based approach to the process validation lifecycle.
  • Recognize the value of the requirements of management’s responsibilities within the PQS.

Speaker: Mr. Maurice Parlane


Registration Fee
  • ISPE Member 8,000 THB
  • Non ISPE Member 12,500 THB


Download Flyer

Register to join now!


Attendance is restricted to a maximum of 40 participants.


Return to event index