Process Validation Network
Presentations, Workshop and Networking
Take homes
Cleaning program development – A Life cycle approach
Regulatory requirements, Strategy in creating Risk based feasible Cleaning Validation plans
PPQ readiness strategic methodology
Prices
Membership fee: 3250 DKK
access to two events
–22nd September 2022
– 3rd March 2023
Single event fee 1950 DKK (access to either event)
Where
IDA Conference center, Kalvebod Brygge 31-33/ 1780 Kbh V
When
22nd September, 2022 08:30-15:00
Agenda
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
Workshop
More info? E-mail: info@valideire.com
REGISTER BELOW latest 15th June 2022 to ensure a place
Selected members include:
