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

Dr. Deepak Haldankar

President Technical Akums Drugs & Pharmaceutical Ltd.

Dr. Damodharan M

Chief Quality Officer Sai Life Sciences Ltd.

Mr. Abhay Srivastava

President Operation Mankind Pharma

Dr. Ravi Prakash

Sr. VP Operations Strides Pharma

Mr. Prabir Kumar Pal

Sr. VP Quality & Compliance Alkem Labs

Ms. Minoo Biju

Head Global Regulatory Affairs Piramal Pharma Solutions

Mr. Aniruddha Mehta

Head QA IT Alembic Pharma

Dr. Udaykumar Rakibe

Founder PharmaMantra

Amit Guru

Regional Director, Solution Engineering, APAC Sparta Systems A Honeywell Company

Santhosh A F

Area VP – India, ASEAN & ANZ Business Sparta Systems, A Honeywell Company

Mr. Bhavish Agarwal

Founder FDAlytics

Anthony C. Warchut

Principal/Member AC Warchut GMP Consulting LLC

Mr. Gopi Reddy

Head Corporate Quality Assurance Syngene International Limited

Mr. Rishi Vyas

Head Quality Operations Sun Pharmaceuticals

Mr. Suryamohan Surampudi

Head Of Digital & Process Excellence Dr. Reddy's Laboratories Ltd

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

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