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.

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.

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.

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.

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.

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.

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