4th Annual Cleaning Validation 2024


A Practical Approach



August 22nd-23rd, 2024

Radisson Blu Mumbai International Airport



4th Annual Cleaning Validation 2024 – A Practical Approach

4th Annual Cleaning Validation 2024 – A Practical Approach

About the Event

Cleaning validation is an essential process in the pharmaceutical industry that ensures that all equipment used in the manufacturing process is cleaned to prevent cross-contamination and ensure product quality. Eminence Business Media acknowledges the need of focused training on the main pillars of an effective master cleaning validation plan and introducing a program that covers elaborated discussions and case studies for cleaning cycle, cleaning chemistry, regulated equipment, , test limits and periodic monitoring; and announcing 4th Annual Cleaning Validation 2024- A Practical Approach. This program offers 2 day learning followed by 1 day follow up virtual session, this way the attendees can implement the 2 day learning in their professional lives and come back with follow up questions during scheduled virtual training.

From the insightful discussions and interactions between the eminent speakers and attendees we have ensured the entire training program would be very communicative. We at Eminence Business Media believe that learning should not stop only by brush ups or doubt solving, it should be evaluated by Case studies. Hence, after deliberating with experts with immense experience in the industry, we have drafted important subject of Cleaning Validation with practical learning.

Sincerely, TEAM-EMINENCE BUSINESS MEDIA



WHY ATTEND?


BENEFITS OF ATTENDING


  • Analyse the best of recent trends and advanced innovations for more efficient Cleaning Validation.
  • Learn the practical approach with case study discussions and live examples.
  • Discuss your queries at the live Q & A sessions and reap the benefits from the extended 6-month support for continuous learning even after the event.
  • Take advantage of follow-up virtual session to address real time challenges after implementing 2 day in-person learning.
  • Share the dais with the industry leaders and network with your peers to understand what they do differently to be successful.

Key Highlights


  • Specially designed practical sessions.
  • Impressive array of speakers, witness the strength of 300+years of experience in 2 days.
  • Focus on practical case studies and example based learning.
  • Overcome the challenges and be ready to upskill/upgrade your Cleaning Validation Program.

Pricing



VENUE: Radisson Blu Mumbai International Airport

Standard Pricing

INR 40,000 + GST

USD 1,000 + GST

Onsite Registration

INR 50,000 + GST

USD 1,200 + GST

*These prices are applicable for pharmaceutical companies only.

Speakers

Dr. David W. Vincent

Chief Scientific Officer

VTI Life Science.

Dr. David W. Vincent

Chief Scientific Officer(CSO) of VTI Life Science.

Dr. Vincent has over thirty-four (34) years of experience in the healthcare industry specializing in the Biotechnology and pharmaceutical industries. He has over (29) twenty-nine years dedicated to the field of Commissioning, Qualification, and Validation (CQV) He has B.Sc. degrees in industrial microbiology, as well as a Master of Public Health and Ph.D.

He has hands-on experience in many areas of Regulatory Affairs, Quality Assurance, Commissioning/Qualification, and Engineering including regulatory submission preparation, Cleanroom Design Review, Microbiology Laboratory setup and qualification. He is solid in Upstream and Downstream Process Development and Validation. He is a leading expert in developing and implementing Cleaning Development and Validation, Aseptic Process, Contamination Control, and Environmental Monitoring Programs. Most of his career has been in the biological vaccine industries but he has also supported the Medical Device, Biopharmaceutical, Pharmaceutical, Nutraceutical, and biological industries.

Dr Vincent is an ASTM committee member for Manufacture of Pharmaceutical and Biopharmaceutical Products - E55 (20-07), Microbial/Sterility Assurance for Pharmaceutical and Biopharmaceutical Products - E55.06 (20-01), WK74412 - New Standard Critical Airflow Visualization and WK69826 - Standard Template for Environmental Monitoring Trend Analysis, Best Practices for Microbial Control of ATMP, and Cleaning Quality by Design, and Risk-Based Cleaning. He co-authored the ISPE GUIDE: Cleaning Validation Lifecycle – Applications, Methods & Controls. ASTM Led for Developing and Managing Contamination Control Strategy.

He taught at San Diego State University (SDSU) for their Masters of Regulatory Affairs Degree program in the Field of Validation Technology RA-776. Inducted into Delta Omega Honorary Society in Public Health was founded in 1924 at Johns Hopkins University within the School of Hygiene and Public Health to promote the graduate study of public health, and to recognize outstanding achievement in the new field.

Mr. Jayakumar A V

President Quality

Ajanta Pharma Limited

Mr. Jayakumar A V

President Quality - Ajanta Pharma Limited

Mr. A V Jayakumar has completed his master's in analytical chemistry from Sardar Patel University, V V Nagar Anand, Gujarat. He is a senior quality and compliance professional with over 28 years of experience. He started his career with Torrent and subsequently associated with Cipla, Aurobindo, USV, and Glenmark. At present, he is responsible for the global quality operations of Ajanta Pharma Ltd.

He is an expert in evolving sites from scratch to meet all SRA compliance requirements. He is also skilled at delivering training and has conducted several audits in India and overseas. He has executed several digital transformation programs at his current organization, making laboratory and manufacturing operations are paperless.

During his career, he dealt with all stringent regulatory authorities during inspections, preparing responses and their ongoing compliance program.

Mr. Subhrangshu Chaudhury

Vice President & Head of Quality

Centaur Pharmaceuticals Pvt. Ltd

Mr. Subhrangshu Chaudhury

Vice President & Head of Quality - Centaur Pharmaceuticals Pvt. Ltd

Mr. Subhrangshu Chaudhury is a seasoned professional with over 17 years of extensive experience in the pharmaceutical industry. He is currently the Vice President & Head of Quality at Centaur Pharmaceuticals Pvt. Ltd. Having a strong background in Regulatory and Quality in the pharmaceutical industry. His experience in working with global customers and suppliers has enabled him to adopt global approaches to his work. In his current role as the Vice President and the Head of Quality for MNCsCentaur Pharmaceuticals Pvt. Ltd, Mr. Chaudhury heads all quality-related functions. He has held positions at reputable organizations such as Alembic pharmaceuticals Ltd, Astron Research Limited, Sequent Scientific Limited, USV Limited, and Indchemie Health Specialties Pvt. Limited, solidifying his expertise in the pharmaceutical industry and quality management. With his comprehensive experience and leadership skills, he continues to make significant contributions to the advancement of quality and regulatory standards in the pharmaceutical sector.

Mr. DVS Varma

Vice President-Quality

Sai Life Sciences Ltd

Mr. DVS Varma

Vice President-Quality-Sai Life Sciences Ltd

Varma DVS, did his post graduation in chemistry and carries rich experience of working in the Pharma industry in various disciplines and capacities for 29+ years.

He is currently associated with “Sai Life Sciences Limited” since 2000, prior to which he was associated with “Siris India Limited” between 1994-2000.

He is Instrumental in establishing the Quality Systems across product life cycle and ensure compliance of Quality Systems. Expertise in handling Regulatory as well as client inspections. Hands on experience in implementation of electronic systems to handle Quality systems.

He has handled 500+ customer audits, 10 USFDA audits, 2 PMDA audits and 1 Cofepris audit at Sai Life Sciences Limited.

He has also played an active role in publication of Sai's case study of Technology Transfer process in the 3rd edition of Good Practice Guide on Technology Transfer of International Society for Pharmaceutical Engineers (ISPE).



Who Should Attend

QA/QC

To ensure products meet the required quality standards and comply with regulatory requirements

Regulatory Affairs

To ensure company complies with regulatory requirements for Cleaning Validation as well, amongst other processes.

Analytical and R&D

To develop and validate analytical methods used in the cleaning validation process.

Manufacturing & Production

To ensure equipment is properly cleaned and that the manufacturing process is not compromised by cross-contamination.

Engineering and Maintenance

To ensure the maintenance and repair of the equipment used in the manufacturing process.

Also any other pharma teams that handle cleaning validation and processes.

Join Us

Within the current role, you can apply some of the concepts and techniques that will be discussed over two days at the 4th Annual Cleaning Validation 2024 – A Practical Approach, Mumbai.

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SILVER PARTNER


Pragvas

Pragvas Technologies offers advanced solutions tailored to the specific requirements of pharmaceutical and biotech industries. By integrating latest hardware and software, Pragvas provides compelling solutions which integrates pharmaceutical production, manufacturing, and quality assurance functions. This enables companies to optimize their existing infrastructure for comprehensive regulatory compliance, alongside ensuring data security and integrity and achieving complete paperless operations. Our real-time analytical solutions offer invaluable insights into processes, ultimately enhancing performance and quality with actionable information. Leveraging our technical expertise and extensive domain knowledge in collaboration with Industry experts, we deliver integrated solutions that promise a significant improvements, making us as the preferred partner for our clients.

Learn More

 



CLIENT REVIEWS



Glimpses

After your feedback at last year’s virtual conference, we were advised to come up with this physical conference on cleaning validation. Few of the glimpses from the last year!!

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