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Cleaning Validation; what if it fails, and how to prevent this
Join our Annual Cleaning Validation Masterclass: Cleaning Validation; what if it fails, and how to prevent this. At Progress , we understand the challenges and complexities associated with cleaning validation. With years of industry expertise and a host of successful projects under our belt, we are excited to share our knowledge and help you take your cleaning validation projects to the next level.
Our annual masterclass is designed to be both engaging and empowering, equipped with practical strategies, case studies and personalized guidance from our seasoned experts. Whether you are an experienced professional or a newcomer, this transformative learning experience is tailored to meet your needs.
By participating our Cleaning Validation Masterclass you will:
- gain a comprehensive understanding of the fundamental principles and regulations for cleaning validation;
- learn how to avoid common pitfalls and challenges encountered during cleaning validation projects and discover proven strategies to overcome them;
- benefit from case studies and real-world examples that will improve your problem-solving skills and decision-making skills;
- participate in interactive discussions, ask questions and receive personalized guidance from our experienced instructors;
- connect with like-minded professionals, expand your network and create valuable contacts for future collaborations.
Do not miss this opportunity to gain knowledge, confidence, and practical skills needed to excel in your cleaning validation efforts. Register now to secure your spot. Join us on this transformative learning journey and discover the secrets of a successful implementation. Remember, in the world of cleaning validation, knowledge is power. We warmly welcome you to our Cleaning Validation Masterclass. Sign up now!
New this year – Option to choose for the full day or only the afternoon program
This year, we’re offering the option to attend only the afternoon program of our cleaning validation session. In the morning, we’ll cover the basics of cleaning validation. If you already have a grasp of these fundamentals or have attended our previous cleaning validation masterclasses, you can join us after the lunch break. Start your day with a networking lunch, followed by the interactive afternoon program.
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 will 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.
The program
8:30 – 09:00 Welcome with coffee and tea
9:00 – 09:30 Introduction
9:30 – 10:45 Cleaning Validation, Why and How. Regulatory Compliance, Guidelines, Methodology and introduction to Strategical decisions on
Cleaning Method Development
10:45 -12:00 Cleaning Validation Policy / Project plan, Life Cycle Management, Project Plans, Risk Assessments, Cleaning Effectiveness,
Worst-case Approaches, Family Approaches and Hold times”
12:00 -13:00 Lunch
13:00 – 13:30 Cleaning validation stakeholders
13:30 – 14:00 Quality Control and failure risks in sample handling
14:00 – 15:00 Cleaning process development and Sustainability considerations on validated cleaning processes
15:00 – 15:15 Coffee break
15:15 – 15:40 Explanation case
15:40 – 16:30 Breakouts (Ishikawa / fish bone session)
16:30 – 17:00 Evaluation of findings from break-out session
17:00 – Drinks
Time, date & location
Date: Wednesday 8th of November 2023
Time: 08:30 till 17:00 hours
Location: George Marina Amsterdam
Spaklerweg 10A, 1096 BA Amsterdam
Speakers
Thomas Altmann
Thomas Altmann is the Global Technical Manager at Ecolab specializing in cleaning chemistry, processes, validation, and regulatory compliance. With 20 years of experience, he has advised and optimized cleaning in pharmaceutical, biotechnology, and personal care sectors.
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.
Dennis Wortel
Dennis is an experienced life sciences professional with broad experience ranging from Commissioning & Qualification, Cleanroom Technology and Leading Projects in the pharmaceutical industries.
Language
The primary language is Dutch. Questions, interactions, and inquiries can be either in English or Dutch.
Please note: the training will be delivered in Dutch, but the presentation slides will be in English. Additionally, the guest speaker will be presenting in English.
Who will benefit
This Masterclass is ideal for anyone directly or indirectly involved with Cleaning Validation, i.e. managers, supervisors, process engineers, QA, QC, operations, validation and engineering staff.
Benefits
Progress is an independent consultancy agency. We will share our practical knowledge and experience, gained from many years of experience
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Excluding 21% VAT
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Here you can find the terms and conditions
