Trainings By Informa Markets
Informa


Cleaning Validation Workshop

21 Oct - 22 Oct 2020   |   Virtual Course


Course 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 designed to help the pharma professionals who are dealing in cleaning validation in their day-to-day activity. The past 4 editions of 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 preceding editions were led by world renowned cleaning validation experts along with solution provider stalwarts with their diverse experience in cleaning validation solutions. The 4th edition of Cleaning Validation Workshop witnessed 150 attendees from 52 unique companies and 5 leading brands as workshop partners participating from 17 geographical regions globally over the 2 days.

With 4 successful preceded editions, CPhI Conferences is pleased to announce the 5th edition of the Cleaning Validation Virtual Workshop scheduled on 21-22 October 2020. This workshop will focus on better interpretation and implementation of regulatory guidance, risk assessment for cleaning validation to prevent contamination and ensure consumer safety.

Industry Landscape

Cleaning validation a is documented evidence with a high degree of assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits. The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations.

Global regulatory authorities are keeping close eye on pharmaceutical companies to ensure fulfilment of regulatory guidelines and requirements towards the cleaning procedures and to adopt effective cleaning validation practices.

Pharmaceutical companies are receiving warning letters due to ineffective validation procedures. It has become crucial for pharma & biopharma companies to adopt & implement effective cleaning validation plan. Currently companies are facing many issues in cleaning validation such as:

  • Finding out worst case scenario
  • Selecting suitable cleaning agents
  • Identifying correct sampling locations
  • Determining PDE value
  • Analytical methods & techniques to be used

Program Focus

Understanding regulatory expectations & guidance on cleaning validation
Implementation of visual inspection in cleaning validation
Risk assessment for cleaning and cleaning validation
Calculation of cleaning validation limits using Health Based Exposure Limits (ADE/PDE)
How to determine worst case soil with new science and risk-based approach
Understanding statistical process control and process validation
Identification of correct sampling techniques to be used for cleaning validation
How to maintain validated state

Benefits of Attending


10+ hours of extensive learning on cleaning validation
Interactive case studies and group exercises
Industry experts and well-known trainer
Dedicated Q&A sessions
Exhibitor showcase
Easy networking opportunities

Gold Partner

Silver Partner

Networking Partner


Workshop Trainer

Mr. Koshy George

Senior QA and Validation
Consultant

Workshop Leaders

Andreas Schreiner

Director of Validation
Novartis Pharma Switzerland

Beth Kroeger

Senior Manager Technical Services
STERIS

Fred Ohsiek

Former Senior Specialist
Novo Nordisk

Graeme McKilligan

Independent GMP Consultant & Ex-Lead Senior GMP Inspector with
Medicines and Healthcare products Regulatory Agency (MHRA)

Jenna Carlson

President & Quality Consultant
Mindful Quality

Richard Chai

Technical Service Manager
STERIS Corporation

Rohit Chakravorty

Lead Application Specialist
SUEZ – Water Technologies and Solutions

Dr. Sebastian V.J

Principal Consultant
Director - Development Consulting and Scientific Affairs. PharmaLex

Who Should Attend?


Industries / Categories

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

Designation

  • Vice Presidents
  • Associate Vice Presidents
  • Directors
  • Associate Directors
  • Head/ Plant Head
  • Deputy General Manager
  • General Manager
  • Senior Managers
  • Managers
  • Assistant Managers
  • Senior Executives

Departments

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

Who Should Partner

  • Analytical equipment providers
  • Cleaningagents
  • Samplingdevices/collectors
  • Consultingcompanies
  • Cleaning validation software providers




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