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