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Program Objectives
- To provide a better understanding and an overview of appropriate standards and practices for product testing, manufacturing, storage, handling and distribution.
- To ensure an effective overall approach to product quality control and risk management.
- To understand the practices and requirements before going for a license.
- To understand the definitions of common terms used in this industry.
- To be aware of some of the Code of Federal Regulations.
- To expand the pharmaceutical business in any international capacity.
- To develop documentation / research writing expertise in the Pharma Good Manufacturing Practices area.
- To provide quality inputs in the area of Pharma Good Manufacturing Practices, to working professionals and individuals who have completed their education and willing to contribute in this area.
- To make available to Industry a pool of competent professionals in the area of Pharma Good Manufacturing Practices.
Program Methodology
- Prospective Participants join the program by submitting participation form with necessary participation fee.
- Delivery of Program Kits and Participation material to the participant.
- The participant will go through the program kit and participation material by himself and through BII's centralized support.
- The participant, with support of BII and his own initiative, will participate in the program by:
- Self Study of Program Kit and other issued material.
- Time Bound Preparation of a Research Report on the allocated topic through BII and his own resources (e.g employer, academic institution, library, internet etc). Submission of Research Report to BII.
- Time Bound Completion and Submission of program assignments to BII.
- Interacting with other participating members and organizations through BII Portal
- Spreading awareness about Pharma Good Manufacturing Practices with others through knowledge sharing.
- Time Bound Completion of the Program.
- Receiving Citation & Experience Certificate from BII about objectives achieved during the program.
This program will detail you on
- General approach of Good Manufacturing Practices, Quality Assurance and Regulation; Quality Management in the Drug Industry; A Brief Historical Background of Good Manufacturing Practices.
- US GMP Regulation for Drugs; US GMP Regulation for Biologics; US GMP Regulation for Medical Devices.
- Overview of the International Good Manufacturing Practice Regulation; International Conference on Harmonization (ICH) Guideline; Advantages of Implementation of ICH Guidelines in Non-ICH Countries.
- Drugs and Cosmetics Act; The Central Drugs Standard Control Organization (CDSCO); Need for Strengthening Central Drug Regulatory Agency.
- Introduction and General Considerations; Principle of Quality Assurance; Requirements of Quality Assurance.
- Introduction and General Considerations; Principle of Quality Control; Laboratory Management and Infrastructure.
- Quality Assurance & Quality Control: An Introduction; ISO as a Data Quality Management System; Quality Standards in Pharmaceutical Quality Control Laboratories; Inspection of Pharmaceutical Quality Control Laboratories; Quality Control in Drugs.
- Introduction of ISO 13485; What is ISO; International Standardization; The Hallmarks of ISO Brand; Comparison Between Different ISO Standards; ISO 13485 Standard; Other Coordinating Bodies; Scope of ISO 13485; Requirements of ISO 13485 as a Quality Management Standard for Medical Devices.
- ISO 13485; Historical Background; Making the Transition; The Revision Periods FDA Position on ISO; The New ISO 13485:2003 and ISO 9001:2001.
- Introduction; The Role of ISO 9000; Forty Inventive Principles in Quality Management. Basic Principles of Total Quality Management; Principles of Drug Management; Fundamentals of Total Quality Management; Total Quality Management: Implementation & Tools; Process Validation; Measuring Equipment Calibration.
- Introduction; The Food and Drug Administration Modernization Act (FDAMA); The Good Manufacturing Practices (GMP / Quality System (QS) Regulation; FDA’s Center for Devices and Radiological Health (CDRH); Quality System Audits; Audit of Calibration System; Audit Analysis; Products Emitting Radiations; Quality System Auditing by FDA & ISO Compliance Dietary Supplement Health and Education Act of 1994 (DSHEA).
Program Areas
Deliverables
Program Deliverables include:
Training Kits comprising of Reference Materials and Free Lecture CDs, Support via Internet, Email and Telephone Support.
BII Lecture CDs
BII Courseware
How To Join
In order to join BII 6 Months Program in Pharma Good Manufacturing Practices the prospective participant has to submit the necessary form to the Program Co-ordinator, Bioinformatics Institute of India.
-----------To download Application Form Click Here -----------
Eligibility
The eligibilty for this program is graduation in any discipline. Highly interested participants in final year can also apply.
Program Fee
BII Program Participation Fee for this program is Rs 7,500 (for participants based in India / USD 600 (for overseas participants). Payment is to be made through Demand Draft / Telegraphic Transfer in favor of Bioinformatics Institute of India.
Examination Fees
Every student has to pay Rs.200/- per module as examination fees . Examination fee for overseas participants is USD 25 Per Module.
Program Duration
The program duration is 6 months.
Evaluation
At the end of the duration of a program, participants go through a well defined written examination process which is held on all India basis.
Participants from the companies have been associated with
Participants, who have enrolled in the BII Programs, are from the below mentioned reputed Pharma sector companies. They have already enhanced their skills and knowledge and have gained an upper edge over their competitors. The few companies to mention are Alembic Ltd.; Alkem Labs; Anjan Drugs; Apollo Hospita; Associated Capsules; Aurbindo Pharma; Biocon Ltd; Blue Cross Lab; Cadila Pharma Ltd.; Cipla Cosmic Indl Lab; Dr Reddy's lab;,Elder Pharma,; Emcure Pharma; Erica Fact Consultant; Fermenta Biotech Ltd; Gland Pharma; Glaxo ;Glochem Ind. Ltd ;Hikal R & D Centre; Ind. Swift Labs; IPCA Lab; Jai Research Foundation ;Johnson & Johnson; Jubilant Organosys Ltd ;Leben Lab Pvt. Ltd; Lupin Ltd.; Marck Biosciences; Matrix Laboratories Ltd;. Mechelonic; Medrich Pharma; Micro Labs Ltd ;Midas Care Pharma; MSPL Ltd; Nicholas Piramals; Medrich Pharma; Micro Labs Ltd; Midas Care Pharma; Orchid Pharma; Panacea Biotech Ltd; Ranbaxy Lab; Quintiles; Sandoz Pvt. Ltd; Sharon Bio. etc.
BII also provides placement assistance to the participants who have successfully completed their programs.
-----------To download Application Form Click Here -----------
For further details and enquiries
| India and other Countries
| USA and Canada |
Program Co-ordinator
6 Month Program in Pharma Good Manufacturing Practices
Bioinformatics Institute of India
C-56 A/28, Sector - 62
Noida - 201301, UP(INDIA)
Tel : 0120 - 4320801/02
Mob : 09810535368
| Jitendra Chaudhary
INTERNATIONAL ACADEMIC COUNSELLOR
+91-9818473366 |
| E-mail : info@bioinformaticscentre.org
| Email: global@bioinformaticscentre.org
|
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