• DATE
    27th Sep 2018
  • LOCATION
    Mumbai, Maharashtra, India
  • Starts At
    08:30 am
About Cleaning Validation Workshop

Cleaning validation plays a crucial role to verify the effectiveness of cleaning procedures and ensure no risks are associated with cross contamination which harms the patient safety.

Global regulatory authorities are keeping close eye on pharmaceutical companies to ensure fulfillment 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 practices and procedures.

To ensure that companies successfully pass FDA inspections and to also make sure that it follows effective cleaning validation techniques, CPhI is pleased to introduce/announce ‘Cleaning Validation Workshop’ which is scheduled on  27th - 28th  September 2018 in Mumbai.

This unique training covers a systematic evaluation and understanding of cleaning validation regulations, risk reduction, focusing on development of cleaning validation protocol, method validation, sampling techniques and risk evaluation and control.

ATTENDEE PROFILE
Directors/Associate Directors/ VPs/ AVPs/ Plant Heads/Site Heads/Managers/Senior Managers/Assistant Managers/ General Managers/Executives from:

  • Quality Assurance
  • Quality Control
  • Manufacturing
  • R&D
  • Validation
WHY ATTEND?
  • Meet learn and interact with Andrew Walsh
  • Explore the latest solutions catering to cleaning validation
  • Engage with your peers to expand your network
Workshop Trainer

Andrew Walsh

President at Center for Pharmaceutical Cleaning Innovation

Andrew Walsh is a highly experienced Cleaning Validation SME with 38 years of Manufacturing/QA experience and 28 years of "hands-on" Validation experience working for Pharmaceutical and Biologics companies such as Johnson & Johnson (three companies), Schering-Plough and Hoffmann-La Roche. Andrew has developed Cleaning Validation Policies, Master Plans and Cleaning Process Development Reports, developed and validated HPLC and TOC swab methods, wrote and executed Cleaning Protocols and wrote Reports and has lead global teams developing and writing International Standards on Cleaning. Prior to joining the Pharmaceutical industry Andrew worked for 10 years at the Colgate-Palmolive and Clorox companies as an Analytical Chemist and Microbiologist. Andrew has a B.S. and M.S. in Biology (Microbiology) and is a certified Lean Six Sigma Black Belt and an accredited Lean Six Sigma Trainer.

Andrew was a co-author of ISPE’s Risk-based Manufacture of Pharmaceutical Products Guide (Risk-MaPP) and is currently leading a global team Cleaning Validation SMEs that wrote and published the new ASTM E3106-17 "Standard Guide on Science-Based and Risk-Based Cleaning Process Development and Validation" and are working on additional ASTM Standards to support Cleaning Process Development and Validation.

Andrew is President of the Center for Pharmaceutical Cleaning Innovation (CPCI) a not-for-profit research organization, whose purpose is to support the implementation of the science, risk and statistics-based approaches of the ASTM E3106-17 Standard Guide "Science-Based and Risk-Based Cleaning Process Development and Validation". CPCI will be supporting pharmaceutical, biologics, nutraceutical, cosmetic and medical device companies through its research into developing new technologies (2 Patents Pending) and through its educational offerings (publications, courses and workshops) and its educational opportunities for students.

Andrew is also President of Clean6Sigma, LLC a consulting and contract services company guiding companies in the implementation of science, risk and statistics-based approaches to Cleaning Process Development and Validation using their trademarked "Cleaning Validation for the 21st Century®" and "Clean6Sigma®" programs.

Andrew was also an Industry Professor in the Pharmaceutical Manufacturing and Engineering Graduate Program at Stevens Institute of Technology from 2008 to 2015 where he created and taught courses in Pharmaceutical Validation and Lean Six Sigma

Speakers

Dr Mithilesh Trivedi

Head, CQA, BDH Industries Ltd.

Dr Upendra Bahuguna

Head - Quality Management, Zydus Takeda Healthcare Private Limited.

Sanjay Sharma

Sr General Manager and Head Technology Transfer, Lupin Ltd.
Key Topics
Current regulatory environment and expectations
Introduction to the new ASTM E3106-17 ‘Standard guide for science based and risk-based cleaning process development and validation
Calculation of cleaning validation limits using Health Based Exposure Limits (HBELs)
Cleaning process developments - Cleanability Studies (determination of Hardest to Clean)
Risk-based selections and justification of analytical methods
Total Organic Carbon (TOC) Analysis
Risk evaluation and risk control strategies
Panel Discussion
Comparison between cleaning validation Vs. US FDA newer cleaning validation guidelines:

Understanding regulatory guidelines play a crucial role to implement the cleaning validation processes correctly to avoid scrutiny from FDA and other federal bodies. We have organised this panel discussion to address various challenges in adopting and understanding regulatory guidelines and expectations with reference to cleaning validation.

KEY DISCUSSION POINTS:

  • Overview of general cleaning validation processes taken place during drug manufacturing
  • Interpretation and implementation of FDA guidelines and requirements for cleaning validation processes
  • Challenges in implementing cleaning validation as per FDA guidelines and requirements
  • 21st century approach to validation: US FDA Process Validation Guidance
Key Highlights/USPs of the Workshop

Cleaning Validation Process

Content covering all the aspects of cleaning validation process and techniques

Trainer

Trainer with 28+ years of "hands-on" Validation experience

Case-studies

Interactive case study/exercises

Q&A

Dedicated Q&A sessions

12+ hours of learning

12+ hours of learning from a highly experienced Cleaning Validation SME with 38 years experience

 

Networking

Networking

TESTIMONIALS
Event Partners

Any questions? Drop us a note

Contact Us

For Exhibiting & Partnership Enquiries
Dhruv Khanna
+91 226172 7305 / +91 9930307433
dhruv.khanna@ubm.com
For Delegate Enquiry
Barkat Mirza
+91 226172 7145 / + 91 99209 08212
barkat.mirza@ubm.com
For Content
Amruta Manjrekar
+91 22 6172 7006 / +91 9773438471
amruta.manjrekar@ubm.com
For Marketing & Communications
Ankit Gandhi
+91 22 6172 7078 / +91 98923 10951
ankit.gandhi@ubm.com
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