Masterclass Cleaning Validation

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.

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 – 12:00              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 

Date:                    19th of November 2020

Time:                    08:30 till 17:00 hours

Location:               Progress-PME Training facility

                            Bijlmermeerstraat 20, 2131 HG Hoofddorp > view on Google Maps 

 

* the location might be subject to change due to Covid-19 precautions. We will keep you informed.

Speakers

Paul Tiemeijer

As Senior Consultant, Paul has designed custom-made cleaning validation strategies supported with a program for a bottom line implementation, involving compliance GAP analyses, implementation of policies, SOPs, master plans, validation -protocols, reports and training. 

Eddy Breed

Eddy is an experienced life sciences professional with broad experience ranging from Process Development, Technology Transfer and Commissioning & Qualification for manufacturing processes of human and veterinary medicines.

Anja Slikkerveer

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.

Language

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.

Benefits

Progress-PME is an independent consultancy agency. We will share our practical knowledge and experience, gained from many years of experience.

Pricing

You can refund your ticket up to 7 days before the Masterclass, free of charge
Excluding 21% VAT

Early Bird Special

€650
499
95
1 ticket
  • Free cancellation
  • Lunch & drinks
  • Certificate
untill 24 sep

Regular ticket

650 1 ticket
  • Free cancellation
  • Lunch & drinks
  • Certificate
Populair

Package deal

1.799
80
4 tickets or more, €449,95 per ticket
  • Free cancellation
  • Lunch & drinks
  • Certificate
Best value
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.

Additional cleaning

All our rooms are cleaned thoroughly and frequently. Also external meeting locations will be cleaned additionally. Hand sanitizer, alcohol, masks and gloves 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.