aBOUT THE COURSE
This course has been designed by BARQA to provide you with the necessary skills and tools to prepare and host a regulatory inspection and to facilitate the response and follow-up to the inspection findings. The course encompasses inspections at sponsor and contract research organisation sites, as well as at the investigator site.
|
|
To Download the Course PDF & Registration Form, see below
gcp_regulatory_inspections_mumbai_programme_v_2.pdf | |
File Size: | 405 kb |
File Type: |
To know more details about this course and other courses available from BARQA - CLICK HERE
WHO SHOULD ATTEND
The course is designed for all those who will come into contact with the inspectors during a regulatory inspection and will be particularly useful for those given responsibility for preparing and hosting the inspection and managing the response process following the inspection:
- QA professionals
- Investigators
- Site managers
cOURSE TUTORS
Bruce Seymour-Taylor - Course Principal
Director, Seymour-Taylor Consulting Ltd Bruce has 30 years experience in the Pharmaceutical Industry on a global basis, and has held many management roles in different Pharmaceutical companies in Clinical Development and Clinical Quality Assurance. He has thorough knowledge and experience in dealing with regulatory compliance and GCP issues in the clinical field on a global basis. Bruce Seymour-Taylor is the Founder and Managing Director of Seymour-Taylor Consulting Ltd. Bruce is an active member on the GCP committee of the British Association of Research Quality Assurance (BARQA) and has currently associated with ACRP in their training initiatives. With the advent of clinical quality assurance in Europe in the mid 1980’s, Bruce was asked to set up an International Clinical QA group for Warner Lambert/Parke-Davis. |
|
Solomon Yimam, MT (ASCP)
Assistant Country Director - US FDA India Office Solomon has more than twenty five years of public health related compliance, enforcement and surveillance experience. Prior to joining the FDA’s India Office, Solomon worked as a reviewer in U.S. FDA’s Center for Biologics Evaluation and Research (CBER). In CBER, he participated and contributed as a Bioresearch Monitoring review team member in the review and approval of several novel and important FDA regulated products that contributed significantly to the mission of FDA. Solomon has conducted numerous compliance oversight investigations, including compiling, reviewing, and evaluating investigative materials and preparing investigative reports. |
Shehnaz Vakharia
Principal Consultant, Theraverity Shehnaz Vakharia, Founder and Principal Consultant, Theraverity, is a clinical research professional based in India with over fourteen (14) years experience in clinical research and nine (09) years experience in conducting a wide range of quality assurance audits and assessments. She has conducted over 170 audits in India, China, South Korea, South Africa, Senegal, Ghana, Gabon, Kenya, Turkey, Singapore, Taiwan and Hong Kong. Her auditing experience ranges from Investigator Site Audits (GCP) to System Audits for Clinical Research, Data Management, Medical Affairs (including Drug Safety), Bioavailability (BA) I Bioequivalence (BE) Facility Audits and Vendor Evaluations. |
|
For Assistance, Contact us with the below required details
For Quick Queries, Contact us at:
Blackarrow Conferences
Ms Parsha Rahman +91-99205 99259
email: [email protected]
Blackarrow Conferences
Ms Parsha Rahman +91-99205 99259
email: [email protected]