SUMMARY REPORT OF National Level Seminar on Data integrity and Quality metrics: Regulatory Compliance

Transcription

1 SUMMARY REPORT OF National Level Seminar on Data integrity and Quality metrics: Regulatory Compliance A GUJCOST sponsored one day National level seminar On Data integrity and Quality metrics: Regulatory Compliance was organized on 20th February 2018 at Anand Pharmacy College, Anand. The seminar enabled each of the participants to discuss, share and clarify various concepts like Data Integrity and Quality Metrics: Recent Regulatory Expectations, Key aspects of Data Integrity, Calculation of Quality Metrics and Regulatory Compliance for Pharmaceutical Industries. Total 88 participants were benefited by this seminar. The inaugural function was graced by the presence of Smt. Jyotsnaben K. Patel, Honorary Secretary, Shri Ramkrishna Seva Mandal. Mr. Sanjaykumar Jain (Executive Vice President Amneal Pharmaceuticals Limited, Ahmedabad) was the Chief Guest and Mr. J. Ramniwas (CEO & Managing Consultant, Sai Pharma Solutions Inc, Vadodara) was the guest of honour. The entire event was co-ordinated by Dr. Kalpana G. Patel, Academic Head and PG Coordinator under the leadership of Dr. Tejal R. Gandhi, Professor & Principal, APC, Anand and Dr. Mukesh Gohel, P. G. Director & Professor, APC, Anand.

2 Dr. Tejal R. Gandhi, welcomed the participants and gave them the glimpses of the seminar. The function was also graced by Dr. Mukesh C. Gohel, who shared his words of wisdom, encouraging participants to think beyond the stipulated knowledge and learn new happenings in world of pharmacy.

3 The chief guest of the function, Mr. Sanjaykumar Jain, addressed the audience about the importance of Data integrity in day to day life and in the field of pharmaceuticals. The Honorary Secretary of the Shri Ram Krishna Seva Mandal, Smt. Jyotsnaben K. Patel, welcomed the audience to this Data Integrity seminar, further she addressed the audience about the importance of data integrity and how the best practices in pharmaceutical industries can ultimately benefit the society.

4 The vote of the thanks for the inaugural function was proposed by Dr. Kalpana G. Patel, Professor, Anand Pharmacy College, Anand. The whole seminar was compared by Ms. Jenee Christian and Ms. Kesha Patel, Assistant Professors, Department of Pharmaceutical Chemistry, Anand Pharmacy College, Anand. The Resource Persons were from Regulatory frame work and Pharmaceutical Industries, Mr. Sanjaykumar Jain (Executive Vice President, Amneal Pharmaceuticals Limited, Ahmedabad), Ms. Dimple N. Patel (Assistant General Manager, QA, Amneal Pharmaceuticals Limited, Ahmedabad), Prof. M. C. Gohel (Research Director & Professor, Anand Pharmacy College, Anand), Shri J. Ramniwas (CEO & Managing Consultant, Sai Pharma Solutions Inc, Vadodara). They delivered the sessions on the theme of data integrity and addressed various challenges and broad outlook on violation observed in pharmaceutical industries. Also they shared their practices to overcome data integrity issues. In the seminar Mr. Sanjaykumar Jain (Executive Vice President, Amneal Pharmaceuticals Limited, Ahmedabad), delivered a lecture on Data Integrity and Quality Metrics: Recent Regulatory Expectations. In his lecture, he briefed the participants about relation between quality and culture, trust and integrity. He further detailed emphasis on GMP rules, data integrity and co-related with Pharmacist s Oath.

5 Next expert talk was given by Ms. Dimple N. Patel (Assistant General Manager, QA Amneal Pharmaceuticals Limited, Ahmedabad) on Key Aspects of Data Integrity. She explained about meaning of data integrity as per industry point of view, Data Integrity Attributes, Sources to achieve highest standards of Data Integrity, Data Integrity Violations, Causes and Consequences of Data Integrity Issues, What Inspectors look for DI audit etc.

6 After luncheon, Dr. Mukesh C. Gohel (Research Director & Professor, Anand Pharmacy College), had delivered a lecture on Calculation of Quality Metrics. In his talk, he discussed about quality Metrics as future need of the pharmaceutical industry for marketing the drug product in the regulated market. He also increased awareness to the participants about era of quality control to good manufacturing practices to quality by design and finally quality metrics. Further, he described about calculation of quality metrics with examples. He mentioned about different guidelines for quality metrics and data integrity. Last session of the seminar was delivered by Shri J. Ramniwas (CEO & Managing Consultant, Sai Pharma Solutions Inc, Vadodara). He had delivered talk on Regulatory Compliance for Pharmaceutical Industries. He highlighted key points related to meaning of compliance, cost of non-compliance, need to ensure compliance, eight elements of effective compliance program, categories of regulatory issues, regulatory compliance management etc.

7 Lastly the programme was ended with certificate distribution by Ms. Hemangini Patel and High Tea. Feedback from participants were gathered and evaluated which shows the excellent rating and success of seminar. PRESS RELEASE / MEDIA REPORT