Lifecycle Process Validation (PV) remains one of the most important and commonly misunderstood topics in the pharmaceutical industry. How many lots should we make? Are we taking enough samples? Do we need to use statistics in our protocols? The real question may be: are we even focusing on the right questions?

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.

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 improve ent.
• 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.

processs validation

1. Online Registration Browse website https://www.ispeth.org/event/ispeth-pv/, fill-in delegate details and click submit 2. Confirmation ISPE staff will confirm your registration status via email. If not receive email within 2 working days after submitted the form, please contact our staff. 3. Payment Make a payment to reserve your seats and capture/ scan transferred evident i.e. payslip to email REGISTER@ISPETH.ORG For pharmacists who attend this course will receive 11.5 CPE accredits. REGISTRATION CLOSES ON 15 JULY 2024 OR WHEN ALL SEATS ARE FULLY RESERVED (LIMITED TO 40 SEATS). FIND OUT MORE INFO & CONTACT US: WWW.ISPETH.ORG EMAIL: REGISTER@ISPETH.ORG T: +6688-090-4664