Masterclass Cleaning Validation
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Best in class practices
Many cleaning validation professionals find it challenging to deal with regulatory expectations on product residue limits. Global regulatory expectations on this topic differ and many manufacturers with EU and global markets are struggling with the lack of clarity and hybrid approaches.
In guidance, the EMA made it mandatory to establish Health-Based Exposure Limits (HBEL) for all the drug products based on Permitted Daily Exposure (PDE) Values as described in Appendix 3 of ICH Q3C (R4). The guideline was soon followed by a Q&A on the implementation of the above guideline and is a must-read. Recently we find (Dutch) regulators pushing some key items in this Q&A document as mandatory. This could impact your QMS and even your business.
Our full-day Masterclass will provide you with a deep-dive in Cleaning Validation. In the morning session, you will learn our best in class practices on Regulatory Compliance, how to write your Policy, PQ strategies and Life Cycle Management. In the afternoon we dive into product residue acceptance limits calculations, using the conventional (therapeutic based) and PDE based approaches. With hands-on and practical sessions you will learn all the essential insights. In cooperation with subject matter expert Anja Slikkerveer, an independent toxicologist at d2team, we will explain the interpretations and determination of PDE values.
You will learn all about:
Strategy & Policy
You will learn how to set up an efficient and effective cleaning validation policy and PQ strategy that among other aspects involves the PDE per EMA and the Process capability expectations of the FDA.
In the morning session, we outline the basic principles for a compliant Cleaning Validation Lifecycle Management System. We will specifically focus on risk management tools and key aspects that are critical for a successful process cleaning validation.
Calculating and implementing PDE
You learn how to use or integrate PDE into your new or existing Cleaning Validation policy. We show you how to integrate PDE based limits and traditional acceptance limits in a hybrid approach. In break-out sessions, we challenge you to calculate traditional and PDE based acceptance limits.
08:30 – 09:00 Doors open
09:00 – 09:30 Introduction
09:30 – 11:00 Cleaning Validation Principles
11:00 – 12:00 Life Cycle Management
12:00 – 12:45 Lunch
12:45 – 13:30 Introduction Acceptance Limits Calculations
13:30 – 14:30 Deep-dive determine and obtain PDE values (guest speaker)
14:30 – 16:30 Break out session with consultants & Case studie on calculating acceptance limits
16:30 – 17:00 Evaluation and Q&A
17:00 – Drinks & networking opportunities
Anja is an independent toxicologist at d2team. She is experienced in safety assessments in support of manufacturing, including impurity and excipient assessments, and derivation of PDE. She was a member of the ICH Expert working groups on Q3D.
The primary language is English. Questions, interactions and inquiries can be either in English or Dutch.
Who will benefit
This Masterclass is ideal for anyone directly or indirectly involved with Cleaning Validation, i.e. managers, supervisors, process engineers, and QA, QC, Operations, Validation and Engineering staff.
Progress-PME is an independent consultancy agency. We will share our practical knowledge and experience, gained from many years of experience.
You can refund your ticket up to 7 days before the Masterclass, free of charge
Excluding 21% VAT
Early Bird Special
Lunch & drinks
Lunch & drinks
Lunch & drinks
Our Covid-19 policy
Money back guarantee
No vouchers or changing dates. We will reimburse all tickets if the Masterclass can’t take place. You can always refund your ticket 7 days before the event.
All our rooms are cleaned thoroughly and frequently. Also external meeting locations will be cleaned additionally. Hand sanitizer, alcohol and masks are available for those present
Keeping the required distance
Walkways are redesigned and rerouted to make sure we meet the required distance set by the authorities. Tabels and seats are placed differently to allow more distance between.