Workshop on Effective Audit Strategies for Pharmaceutical Industry

Workshop on
Effective Audit Strategies for
Pharmaceutical Industry
Hotel Melia, Kuala Lumpur
18th March, 2015
Why should you attend?
Audits are inevitable in the highly regulated pharmaceutical industry. With outsourcing
becoming the norm, audits have become even more critical for companies who
outsource and their vendors/suppliers/service providers. Using examples, exercises
and discussion, learn the basic regulations that govern audit requirements and
practical techniques to conduct and/or face audits for best results.
Key topics to be covered in the workshop
Importance of audits in the pharmaceutical industry
Auditing in a GxP world
Audit strategies in a changing regulatory environment
Managing expectations of management, clients and regulators
Tips and techniques for best outcome
Who should attend?
The attendees will result primary from the following 4 areas: Pharmaceuticals, Medical devices,
Biotechnology and Academia. Personnel from the following departments will benefit from the
 Quality assurance staff
 Independent auditors
 Regulatory affairs staff
 Sponsors
 CMOs/CROs/Service providers
 Business development personnel
Trainer’s Profile
Dr. Ranjani Nellore, Ph.D. RAC
Ranjani Nellore, Ph.D. RAC is a regulatory affairs certified professional with 20 years of
pharmaceutical industry experience in USA and India. Previously, she had worked as Director,
regulatory affairs for Dr. Reddy’s Laboratories, prior to that she had worked as principle research
scientist at Roche, USA. She is an experienced GMP and GCP auditor well-versed with regulatory
expectations. She is an invited speaker at national and international meetings and has rendered
customized training programs to global companies.
Graduated in B.Pharm from Bombay University, Ranjani has received her Ph.D. degree in
Pharmaceutical Sciences from University of Maryland, Baltimore.
She has now established Pharmatopia Pte Ltd, a consulting company in Singapore to provide
regulatory consulting, auditing and training services to the global health science industry.
Registration Fees
700 MYR per person(inclusive of tax)
*10% group discount for group of 3 or more. Registartion fees include training kit, twice refreshments and
Registration Process /Query
 Fill up the registration form and send us in email to [email protected] with subject line
“Audit Strategies Workshop”, write to this same email if for any query. Please find the details of
the payment in Registration form. You can also submit registration form online.
 Call us at +91 99453 18216 / +91 80 4169 2453
 Visit
our website, find out more details under Clinical Research
Upcoming Workshop page.
Some feedback of ScientiaBio’s workshop on related areas of Clinical Research
“Got better understanding of Clinical Trial, and the trainer learning methodology is very good”Dr Damenthi Nair, Medical Officer, Clinical Research Center, Hospital Ampang
“Thank you for the valuable information provided, as well as the tips of inspection and legal side of
things which was additional help” – Shantini Chelliah, Clinical Research Manager, Novo Nordisk
Pharma Sdn Bhd
“The workshop was well organized. Trainer technique of delivering workshop content was excellent.
Training content fulfilled the expectation” – Nishi Sharma, Functional Co-ordinator, Global
Respiratory Clinical Development, Cipla Ltd
“Great International perspective and experience”- Jennifer Harmon, Senior Manager, Duke-NUS
Graduate Medical School, Singapore
A Training Program by