ABOUT EVENT

Align your Validation Program with the FDA’s CSA Approach...

Computer System Validation has been around since the introduction of the FDA regulation 21 CFR part 11 in 1997.
The digital world has evolved at an ever-increasing speed and there was a need for significant change in the regulations and the way validation is done. While all this technology enhances support of Manufacturing, Operations and Quality, CSV remains an obstacle in this progress due to the extensive structured testing and documentation that is required to demonstrate the validation of computer software.
The FDA, recognizing industries CSV challenges, has announced new guidance on "Computer Software Assurance for Manufacturing, Operations, and Quality System Software." This new guidance discusses how CSA can refocus validation streamlining documentation with an emphasis on critical thinking, risk management, patient and product safety, data integrity, and quality assurance.
Understanding the importance of CSA, Eminence Business Media and Compliance Group have collaborated in hosting an online ‘Computer Software Assurance’ event for all pharma, biotech and medical devices companies across APAC region to learn, understand and implement CSA in their organisations.
We have detailed out aspects of CSA and practical applications with case studies that will be presented by expert speakers from FDA Industry Team and GAMP GPG Data Integrity by Design co-authors.
Start your internal pilot studies, update your standard operating procedures (SOPs), implement the paradigm shift TODAY, with the guidance from the source.

Attendee Profile

Industries

  • Pharmaceuticals
  • Manufactures of APIs
  • Finished Products
  • Quality Control Laboratories
  • Pharma Chemicals
  • Automation & IT Companies

Departments

  • QA & QC
  • Regulatory Affairs
  • Research and Development
  • IT Departments
  • Validation
  • Software Development

Professionals

  • Directors, VP’s, CxO’s
  • General Managers
  • Senior Managers & Managers
  • Validation Specialists
  • Auditors

Why Attend?

  • Stay Up-to-Speed with Regulatory Thinking
  • Connect with validation experts within the life sciences industry
  • For knowledge exchange and valuable hands-on learning
  • Shape and magnify your understanding of the regulatory requirements and expectations for the compliance of computerized systems used in pharmaceutical manufacturing
  • Learn to apply quality risk management and risk assessment concepts
  • Excellent networking opportunities to build relationships

Speakers

Mr.Francisco Vicenty

Program Manager Case for Quality USFDA*

Mr.Ken Shitamoto

Sr. Director, IT Quality Engineering Gilead Sciences

Mr.Senthil Gurumoorthi

Director QA Gilead Sciences

Mr.Khaled Moussally

EVP Clients & Regulatory Relations Compliance Group

Mr. Stephen J Cook

VP – Validation and Compliance Compliance Group

Mr. Ron Schardong

Sr. Director, JJ Technology Quality – CSV Johnson and Johnson

Mr.Ray Murphy

Principal Software Quality Engineer Boston Scientific

Ms.Raechelle Raimondo

Executive Director – Global Systems Assurance Abbvie (formerly Allergan)

Ms. Shana Kinney

Associate Director - Validation REGENXBIO Inc.

Mr. Lou Poirier

IT Director, Quality and R&D systems Lantheus Medical Imaging

Dr. M. Damodharan

Senior Vice President & Head, Global Quality & Regulatory Affairs Sai Life Sciences Limited

Mr. Harsha Chulki

Head of Global IT Quality, Compliance & CSV ICU Medical Inc.

Mr. Vipul Doshi

President - Group Quality Assurance and Regulatory Cadila Healthcare limited

Mr. Sachin Bhandari

GM, Global Head Computer Systems Validation Sun Pharma

Mr. Aniruddha Mehta

Head QA-IT, Quality Informatics Alembic pharmaceuticals

Dr. Udaykumar Rakibe

Founder​ Pharma Mantra TM

Partners

NGO Partner

UNITY WELFARE ASSOCIATION

Unity Welfare Association also known as Unity House was formed in February 2020 with the aid of like-minded people with only one goal of empowering and uplifting the under privileged people from Slums. The vast stretch of Mumbai and nearby locations sees a massive number of people staying and struggling against the tide of poverty in the slums. Our volunteers were struck by a surprising truth when visiting some of India's poorest communities. Children as young as five were learning how to make less than a penny in street crime, begging and litter-picking; when every passing second could be spent learning how to lift themselves from the cycle of destitution – through quality education

Unity House wanted to help break this cycle, by building a community of the young – and young at heart – driven to make a difference through volunteering. Within a short span of time we have reached out to hundreds of people to understand their challenges related to Food, education, sanitization, hygiene and even water supply. Our volunteers not only strive to solving these issues but a large number of people who actively can't attend to the cause try sparing time on the available days or weekends and help us maximise our reach.

    We have various programs running currently to help the needy wing of our society.

  • Food for all: We have tied up with local restaurants, wholesale dealers for fruits, vegetables and grocery items. All the possible aid is collected and distributed on a weekly basis to the targeted locations
  • Water & Hygiene: A large number of these people who stay in slums face immense challenge in getting consumable water. We reach out to the local authorities for seeking Municipal water access to at least 2 to 3 access points within a perimeter of area. This helps them to atleast reach out and get water
  • Right to education: The right way of ensuring the future of these kids staying in slums is by providing the tools of education. We conduct night schools and weekend classes with these kids. Our volunteers in large numbers take this onus to at least enable these kids of the primary education. Books, pens, pencils and other stationary is provided to them as an aid and generally

We are a young group of people who do not feel it is our burden but our reason to smile when we reach out and help these people. Growing every day in number our vision is to help as many as possible and make people aware as well about what all tiny bit of help they can provide and how it has a rolling stone effect on the larger number of people.

Media Partners

Choose Your Demo
You will find much more options for colors and styling in admin panel. This color picker is used only for demonstation purposes.
Purchase now