Trainings By Informa Markets
Informa


Cleaning Validation Workshop - INTERNATIONAL

12 Dec - 13 Dec 2022


Workshop Overview

CPhI Conferences has established Cleaning Validation Workshop as a brand which is a “must attend” workshop for the pharmaceutical industry. The workshop is specially crafted to support the pharma & biopharma professionals dealing with cleaning validation in their day-to-day activities. The past 6 editions of the Cleaning Validation Workshop have been well received by industry professionals to enhance their knowledge, exchange ideas, learn from industry peers, ensure business continuity, and shape the future of the pharma industry. The successful preceding editions were led by world-renowned cleaning validation experts along with solution provider stalwarts with their diverse experience in cleaning validation solutions.

With 6 successful preceded editions, CPhI Conferences is pleased to announce the 7th edition of the Cleaning Validation Workshop in a hybrid format scheduled on 12 - 13 December 2022. This two day workshop will have globally renowned trainer share insights via case studies, presentations and Q&A. This course will provide training and understanding of the cleaning validation (CV) process & will cover everything from cycle devolvement to continued process verification. Additional topics include preventing common CV mistakes, smart rinse limits, and pre-CV insights.

Program Focus

  • Risk assessment usage in cleaning validation
  • Cleaning cycle development
  • Calculating cleaning limits
  • Cleaning validation documents
  • Product and Equipment grouping
  • Routine monitoring

Benefits of Attending


  • Gain insights on regulatory requirements and guidelines
  • Understand cleaning validation safety, alarm, and alert limits
  • Create a robust scientific and risk-based CV program
  • Understand nuances of Risk assessments to determine the level of effort
  • Develop an effective and efficient CIP cleaning cycles
  • Understand the required and optional cleaning validation documents
  • Learn about prevention of unnecessary cleaning validation mistakes
  • Determining and then reducing routine monitoring frequency
  • Learn precise steps to release a product after a deviation

About The Trainer

Fred Ohsiek
Former Senior Validation Expert

 

  • 22+ years of pharmaceutical validation experience, specializing in science and risk-based cleaning validation
  • Subject matter expert in regulatory requirements and guidelines for equipment cleaning
  • Real-life practical experience creating, remediating, and improving cleaning validation programs
  • Worked with top companies (Catalent, AstraZeneca [formerly Amylin] Boehringer Ingelheim, Teva, Astellas, Bayer, and Novo Nordisk)
  • Renowned speaker on cleaning validation topics with best-practice techniques
  • One of the authors on the ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the CV acceptance criteria chapter lead.

Media Partners

Who Should Attend?


Industries

  • Pharmaceuticals
  • Life sciences
  • Bio-Pharmaceuticals
  • API Manufacturers

Departments

  • Quality Assurance
  • Quality Control
  • Production & Manufacturing
  • Validation
  • R&D
  • Regulatory




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