Organizing Committee A STATE LEVEL SEMINAR ON Quality: GxP Organized by INDIAN PHARMACEUTICAL ASSOCIATION, ANAND BRANCH INDIAN PHARMACEUTICAL ASSOCIATION, GUJARAT STATE BRANCH (November 26th, 2011) REGISTRATION FORM Name of Delegate Dr./Mr./ Ms.__________________________________________ Company/ Institute: ___________________________________ Designation: _________________________________________ Field of Specialization: ________________________________ Address for correspondence: ____________________________ ____________________________________________________ ____________________________________________________ ____________________________________________________ Contact Tel. / Fax No.: ________________________________ E-mail ID: _________________________________________ IPA Membership No.: _________________________________ Payment Details: Cheque / DD No. & Date: _____________________________ Amount Rs. ______________________________ Issuing Bank: ______________________________ Delegate Signature: __________________________________ Smt. Jyotsanaben K. Patel Hon. Secretary, Shri Ramkrishna Seva Mandal, Patrons Anand Mr. Hemantbhai J. Patel, President, Shri Ramkrishna Seva Mandal, Anand Dr. Tejal R. Gandhi Organizing Secretary President, IPA-Anand Branch Dr. H. G. Koshia President, IPA-GSB Advisory Committee Dr. J. B. Dave Hon. Secretary, IPA-GSB Dr. Tejal R. Gandhi, President Dr. Kirti V. Patel, Vice President Dr. Kalpana G. Patel, Secretary IPA Anand Branch Committee Dr. Nirav V. Patel, Treasurer Ms. Vaishali T. Thakkar, Executive Member Dr. Purvi A Shah, Executive Member Ms. Veena S. Patel, Executive Member Ms. Hemangini Patel Registration Committee Ms. Dipa Trivedi Ms. Pooja Desai, Ms. Ruchita Gadhavi Catering and Hospitality Mr. Hitesh G. Raval committee Mr. Bharat Patel, Mr. Hardik Rana Mr. Dipesh Patel, Ms. Sarika Johri Mr. Yogesh Patel, Mr. Harmish Mistry Stage Decoration & Mr. Hardik Savsani, Mr. Nisarg Shah Inauguration Committee Mr. Naitik Champaneri, Mr. Bhavin Shah Ms. Dhara Shah, Ms. Neha Panchal Ms. Hiteksha Panchal Media and Publicity Mr. Sunny Macwan Registration Fees: INR (Inclusive of service tax) Students: IPA Members: 150/Students: Non IPA Members: 200/Academia & Industry: IPA Members: 250/Academia & Industry: Non IPA Members: 300/- (Photocopy of this form will be accepted) IPA, Anand Branch, Anand Pharmacy College Opp. Town Hall, Near Grid, Anand 388 001 Phone: 02692-250020 Telefax: 02692-250020 Quality: GxP 26th November, 2011 Organizer INDIAN PHARMACEUTICAL ASSOCIATION, ANAND LOCAL BRANCH & GUJARAT STATE BRANCH ANAND PHARMACY COLLEGE, ANAND (Managed by Shri RamKrishna Seva Mandal) Accredited by NAAC, CGPA 2.68 & Approved by AICTE, PCI Affiliated to Gujarat Technological University, Ahmedabad Registration deadline is 22nd November, 2011. Enrollment is restricted to 100 participants and therefore application will be accepted on first come first serve basis. Participants are advised to make their own travel arrangements. Please send your remittance by Cheque/DD in favor of “INDIAN PHARMACEUTICAL ASSOCIATION, ANAND LOCAL BRANCH, payable at Anand”. A State level Seminar on Dr. Tejal R. Gandhi, Principal, ANAND PHARMACY COLLEGE, ANAND (Managed by Shri RamKrishna Seva Mandal) Opposite Town hall, Anand– 388 001, Gujarat Ph. No.: (02692) 250020 Fax: (02692) 250020 Web: www.apc.ac.in Sponsorer Lincoln Pharmaceuticals Ltd. Cronimach Machinery About the Trust SHRI RAMKRISHNA SEVA MANDAL is a registered society and a public trust established in the year 1954-55, managing more than 20 academic institutions. The trust believes in providing scientific and value based education by maintaining pace with the ever increasing needs of modern educational environment. About the Institute ANAND PHARMACY COLLEGE is one of the leading institute of Gujarat established in 1998 by Shri RamKrishna Seva Mandal. The institute is accredited by NAAC-UGC with CGPA 2.68. Anand Pharmacy College offers B.Pharm, M.Pharm in Pharmaceutics, Pharmacology, Quality Assurance, Industrial Pharmacy and Ph.D. courses. The institute regularly invites learned and eminent academicians, industrialists and dignitaries to deliver lectures and create an environment of enthusiasm and zeal among students and staff members for educational excellence. About the IPA-Anand Branch IPA– Anand Branch was inaugurated at Anand Pharmacy College, Anand on 4th December 2010. IPAAPC has more than 100 life and student members. Branch has organized various activities like Elocution Competition, NPW celebration, Participation in project India etc. How to reach milk city of Gujarat? The milk city Anand is one of the main nodes on the Mumbai-Ahmedabad National Highway No. 8. The Institute is situated in the heart of Anand city as a part of Shri RamKrishna Seva Mandal campus, near an area known as Town hall, at a distance of about 3 kms from the Anand Railway Station. The transportation facility of bus, auto and taxi are regularly available from railway/bus station since early morning till late mid night. Preamble The purpose of the GxP quality guidelines is to ensure that a product is safe and meets its intended use. GxP guides quality manufacture in regulated industries including food, drugs, medical devices and cosmetics. The most central aspects of GxP are: Traceability: the ability to reconstruct the development history of a drug or medical device. Accountability: the ability to resolve who has contributed what to the development and when. Documentation is a critical tool for ensuring GxP adherence. Due to realization of the importance of quality GxP, it was felt necessary by our IPA- Anand Branch to organize a seminar in order to give exposure on the above mentioned topics to researchers, industrialists, teachers and student of pharmacy and allied field. Objectives The main objective is to provide details and knowledge about various facets of GMP, GLP and GCP. Other objectives are as follows: Understanding of the compliance requirements for current Good Manufacturing Practice and Good Laboratory Practice guidelines Applying compliance protocols for generating data according to regulations. Understanding of GMP vs. GLP and Good Clinical Practices Learn how to effectively implement International GMP regulations and guidelines according to EU, WHO, FDA Resource persons Eminent resource persons from academia and industry will be the faculty for the seminar. They will provide indepth information through lectures/discussions on relevant topics. Eligibility This Seminar is intended for the professionals in the research institute and pharmaceuticals/ allied industries, pharmacy teachers, research scholars and M. Pharm students. Programme Schedule Time 09:00 to 9:30 am Topic Registration and Refreshment 9:30 to 10:00 am Inauguration address 10:00 to 11:00 am Lecture I: Good Clinical Practices (GCP) 11:00 to 12:00 am Lecture II: Understanding and Implementing Good Laboratory Practice (GLP) 12:00 to 13:00 pm Lecture III: Overview of current trends of GMP regulations and guidelines 13:00 to14:00 pm LUNCH break 14:00 to 15:00 pm Lecture IV: GMP review guidance for Production and QAQC department 15:00 to 16:00 pm Lecture V: Non-compliance in GMP/GLP inspections 16:00 to 16:15 pm Post-Seminar assessment 16:15 to 17:00pm Valedictory Function and Welcome
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