ABOUT EVENT
The COVID -19 pandemic has created an unprecedented challenge for pharmaceutical companies. Being a heavily regulated industry, it is important to maintain the required GxP and high-quality standards. In this scenario, postponing all the regulatory audits indefinitely, is not a viable option. Effective continued oversite is required to maintain the quality standards of the products. So, the regulatory bodies are now turning to Virtual Audits.
Virtual Audits is a relatively new concept. USFDA has also just released the guidelines for them in April, 2021. This interactive forum will help us understand the difference between both types of audits and how can Virtual Audits be used as an effective tool to complement physical audits in the future.
Technology has been implemented at a brisk pace in the last 12 months. The best way to remain compliant is to adopt new innovations in our organisation. Let's discuss how can we leverage technological advancement to improve our regulatory compliance and become more efficient.
Eminence Business Media, brings this open forum, "Pharma Audit Readiness- Virtual & Physical", where you can put up your questions, participate in debates and get answers for the challenges faced by the teams and collectively implement the learnings.
Why you should not miss it?
- Know the recent guidelines released by USFDA about virtual Audits and their implementations from the expert.
- Learn what regulators expect from us.
- How to always be audit ready?
- How to host a successful Virtual Audit?
- Learn about the new technologies available to remain compliant and improve efficiency.
- Difference between virtual & physical audits and how do they complement each other?
Attendee Profile
Quality Assurance Teams
Corporate Quality
Compliance
Information Technology
Site Quality
Regulatory
Audit Compliance / Audit preparations
Quality Control Teams
Who Should Attend?
Presidents
Vice Presidents
AVP'S
Sr.GMs, GMs & AGMs
Mid Management
Speakers
Partners
Gold Partner
Sparta Systems, a Honeywell Company
Sparta Systems, a Honeywell Company, brings leading-edge quality management solutions to regulated industries. With nearly three decades of experience, Sparta provides enterprise and cloud-based QMS software solutions that help companies go to market faster while minimizing product risks and ensuring compliance. Sparta is an innovator in its field and is driving smart quality with first-of-its-kind AI-enabled quality solutions. By applying the latest digital technologies, our products simplify the process of quality management and guide customers toward proactive quality. visit spartasystems.com
Key Contact person: Ms. Simanti Bose | +91 - 9920901925 | Simanti.Bose@spartasystems.com
Session Partner
FDAlytics
Fdalytics is a GMP compliance and regulation insight platform. It uses FDA inspection data such as Form483s, Warning Letters and FDA Inspector's track record to provide insights into compliance and regulatory vulnerabilities in GXP related process.
The platform is being used by top pharma companies to prepare for upcoming FDA audits or prepare internal audits and to maintain high standard of Quality throughout the year. Fdalytics uses advanced Machine Learning and AI algorithms to provide faster Form 483s search and download, observation search and full FDA Inspector Reports.
Media Partners
