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Cleaning Validation Masterclass

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PDE based acceptance limits, your struggle?

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 on Tuesday November 1st we 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.

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.

Lifecycle management

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 – 12:30           Life Cycle Management

12:30 – 13.15           Lunch

13.15 – 14.00           Introduction Acceptance Limits Calculations 

14.00 – 15.00           Break out session 1 Case study on calculating acceptance limits

15:00 – 15:30           Afternoon break

15.30 – 16:30           Break out session 2 Case study on calculating acceptance limits

16:30 – 17:00           Evaluation and Q&A

17:00 –                       Drinks & networking opportunities 

Date:                    1st of November 2022

Time:                    08:30 till 17:00 hours

Location:               George Marina Amsterdam

Spaklerweg 10A, 1096 BA Amsterdam


€100 discount for HollandBIO members

HollandBIO members can get a €100,- discount. Please contact HollandBIO’s Robbert if you want to make use of it.

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