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 training:  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 lunch. 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 www.scientiabio.com, 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