Process Validation Network

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Cleaning program development – A Life cycle approach

Regulatory requirements, Strategy in creating Risk based feasible Cleaning Validation plans

PPQ readiness strategic methodology


Membership fee: 3250 DKK

access to two events

22nd September 2022

3rd March 2023

Single event fee 1950 DKK (access to either event)


IDA Conference center, Kalvebod Brygge 31-33/ 1780 Kbh V


22nd September, 2022 08:30-15:00


Cleaning program development – Laurence O’Leary

A Lifecycle Approach

QRM, Types of residues, setting acceptable limits, cleaning methods, samling & testing, matrix approach, regulatory framework

Process Performance Qualification Readiness  -Irwin Hirsh

Are we ready for PV (PPQ)? Points to Consider  A high-level but practical overview of points to consider in preparedness.  All points will include risk-based approaches to determine readiness. The session will include a presentation plus a short workshop to provide clarity on how to approach project specific challenges.  Quality engineers are the intended audience but participants with SME or Project management responsibilities will also benefit from participation.Topics included:  Raw materials (CMA); SOPs: Training, Test Plans, and Protocols; Sampling and Analytical Tests; Prerequisite Process Knowledge; Site Readiness (Process FMEA); and Statistical considerations.

Plenary Q&As


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