• DATE
    27th Sep 2018
  • LOCATION
    Meluha The Fern, Powai, Hiranandani Gardens, Central Avenue, 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

Steven A. Weitzel

VP- Technical Operations CANI, Inc.

Steven Weitzel is a highly experienced risk-based process validation SME with 36 years of manufacturing and engineering experience and 25 years technical experience in FDA regulated industry in engineering, manufacturing, process validation and technical marketing.

Weitzel has experience in development and validation of cleaning and microbial contamination control for FDA regulated drugs, biologics, dietary supplements and medical device manufacturing.

He has conducted technical training or consulted for the world's leading pharmaceutical, biotech, cosmetic and medical device companies including Bristol-Myers Squib, Novartis, Pfizer, JnJ, Sanofi, Merck, Teva, Amgen, Genentech, Chanel, Revlon, L’Oreal, Medtronic, DePuy, Henkel/Dial.

Steve has worked in primarily in North America and Europe, but has also worked in India, Saudi Arabia, Iran, UAE, Egypt and Southeast Asia and is familiar with all types of firm size and corporate structure.

He began in Process Development at Dow Chemical in Texas, moved to St. Louis and directed manufacturing of diagnostics and APIs, then went to Mallinckrodt Medical where he was responsible for the facility, critical systems, validation and maintenance of a complex nuclear medicine manufacturing plant.

He moved to Calgon-Vestal division of Merck running manufacturing technical services. While at Calgon-Vestal (now Steris) he transferred from manufacturing/engineering to technical marketing and was responsible for introducing CIP 100 and other cleaning agents and validation support programs to FDA regulated markets. He also was responsible for their disinfectants and Spor-Klenz products for aseptic manufacturing. Since leaving he has been involved in hundreds of facilities, projects and applications related to process validation and contamination control.

Current responsibilities at CANI include external technical support and technical marketing, as well as managing all internal technical operations -manufacturing, validation and quality systems.

Weitzel has published or made over 70 technical presentations on the topics of process validation, risk-assessment and change control; validation master plans; risk-based contamination control; aseptic manufacturing; microbial control and environmental monitoring; critical cleaning and cleaning validation.

He has been involved in several professional organizations including PDA and ISPE, serving on technical, training and policy committees.

Speakers

Lukas Swanson

Global Life Science Applications Engineer, Suez

Manoj Maheshwari

Saksham

Dr Upendra Bahuguna

Head - Quality Management, Zydus Takeda Healthcare Private Limited.

Dr Mithilesh Trivedi

Head, CQA, BDH Industries Ltd.

Sanjay Sharma

Sr General Manager and Head Technology Transfer, Lupin Ltd.

Krishna Prasad

Director- Contract Operations Quality Assurance - Consumer Healthcare, APAC - Pfizer
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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