Sparta Systems’ TrackWise User Group India (TUG India 2016) held its second annual event on April 20, at the Hyatt Regency Mumbai. The event was attended by 32 of Sparta Systems’ customer delegates representing 16 India based customers.
I had the opportunity to present the current trends related to the FDA’s scrutiny of Indian manufacturers and how Sparta Systems can help customers through technology based solutions to stay ahead of the regulatory curve. I also presented a product roadmap that shows the breadth and depth of Sparta’s solution offerings that addresses today’s customer needs as well as future requirements. This presentation was followed by a product showcase (demos) hosted by Amit Guru, Sparta Systems’ India-based Solutions Consultant.
April 21-22, 2016
The 1st annual CAPA & Root Cause Investigation Workshop specific for the Indian Life Sciences companies was held at Meluha The Fern in Mumbai, India. The event was attended by approximately 125 professionals from various job functions including quality operations, regulatory and compliance, manufacturing operations and corporate. It was originally planned for 80+ delegates, however, recent events including a greater number of 483 warning letters issued to Indian pharma and API companies has increased the urgency of these companies to understand the real nature of CAPAs and how they can equip themselves to stay above the fray. The primary theme of the event was “Why is effective CAPA management so critical to remain in business” and included informational sessions related to FDA’s view on CAPA expectations, rules and regulations and how to establish a successful CAPA program. Primary sessions were conducted by Larry Spears, who is a retired Deputy Director of Regulatory Affairs at FDA.
I had the opportunity to present in front of the entire audience due to Sparta Systems’ gold partner status for the event. My presentation focused on the following:
- The realities of FDA’s oversight in the Indian market
- The potential impact on FDA proceedings based on Indian APIs being the largest exporter to the US
- And, how Sparta Systems’ quality management solutions may be able to help Indian companies comply with current and future FDA regulations
Overall my presentation was well received as engaged delegates asked questions and provided feedback at the conclusion, as well as during networking opportunities which offered me the chance to further discuss Sparta Systems’ solutions on a one-to-one basis.
Stay tuned for part four of “Where in the World is Mohan Ponnudurai” coming soon.