The document describes an industry program in pharmaceutical quality assurance and quality control offered through distance learning. The 12-month program aims to enhance knowledge of quality professionals and provide in-depth training in areas like GMP, quality assurance, regulation, and statistics. It covers 7 modules and career prospects in quality assurance, control, auditing, and management are discussed. The program awards a certificate upon completion.

1. INDUSTRY PROGRAM IN PHARMA QUALITY ASSURANCE AND QUALITY CONTROL DISTANCE LEARNING PROGRAM OFFERED BY : BIOINFORMATICS INSTITUTE OF INDIA

2. INTRODUCTION PROGRAM OBJECTIVE PROGRAM METHODOLOGY PROGRAM AREAS CAREER PROSPECTS COMPANIES QUOTES ADMISSION PROCEDURE INDEX PROGRAM AWARD

3. INTRODUCTION Industry Program Pharma Quality Assurance and Quality Control- Distance Participation has Been designed to enhance knowledge of Professionals about the Quality Assurance in and Quality Control for Pharmaceutical Industry and Laboratories. The objective is to impart in-depth and latest knowledge required for a Pharma Quality professional .

4. PROGRAM OBJECTIVE To be the biggest knowledge enhancement movement in the world in the area of Pharma QA & QC. To spread, enhance and share the knowledge in the emerging areas of Pharma QA & QC. To provide quality inputs in the area of Pharma QA&QC to working professionals And individuals who have completed their education and willing to contribute in this area. To develop documentation / research writing expertise in the Pharma QA & QC Domain. To equip participants of the BII Industry Program in Pharma QA &QC to be able to spread awareness in this area by sharing their knowledge with others. To be a platform for interchange and exchange of knowledge in this area by organizing interaction between the members of the program through BII Blog.

5. PROGRAM METHODOLOGY

6. PROGRAM AREAS Module I : Quality Assurance in Pharma Industry-I Module II : Quality Assurance in Pharma Industry-II (WHO Perspective) Module III : Good Manufacturing Practices, Quality Assurance and Regulation Module IV : Quality Assurance and Control Module V : Pharma Regulation Practices & Procedures Module VI : Statistical Quality Control and Biostatistics Module VII : Research Study

7. CAREER PROSPECTS Pharma quality control remains extremely important and specialists in this field will continue to be needed, because of automation, More tasks that once fell to quality assurance engineers can be handled by production workers. There are probably more opportunities in other sectors of the economy, particularly in healthcare where quality assessment is a relatively new idea. Remuneration has now become the central issue for attracting and retaining employees across industries. The compensation structure within the pharma industry has also undergone a sea change over the past couple of years due to the phenomenal growth in this sector, discovers Sapna Dogra. Source: express pharma

8. Some of the specific career areas that fall within the scope of QA & QC area include: Quality assurance Technician and Analyst Quality assurance or Control Managers Quality Researcher Quality Assurance Engineer Quality assurance Specialist Quality Assistant Quality Control Inspector Quality Control Engineer Production Manager Health and safety officer Quality Assurance Auditor

9. COURSEWARE OFFERED BY BII

10. Some of our students are associated with the following renowned companies Merck India Deptt. Of Plant Molecular Biology Univ. Of Delhi ANR Right Gen Technology Infosys Technologies Ltd. Wipro Technologies Polaris Software Lab Ltd. L&T Information Tech. Ltd. Shasun Chemicals & Drugs Ltd. Pfizer Ltd Cadila Pharmaceuticals Ltd. Aurobindo Pharma Ltd. Ranbaxy Lab Ltd. Bio-Rad Laboratories (I) Pvt. Ltd. A.I.I.M.S. Lupin Ltd. GlaxoSmithKline Elder Pharma Ltd Panacea Biotech Ltd

11. Some of our students are associated with the following renowned companies MSPL Ltd. Vaidik Remedies, Nagpur UV Vitamins BBMB Hospital Chandigarh Sesa Goa Ltd. Uttaranchal Institute of Technology Cipla Ltd. Trabsegene Biotech Ltd Jubliant Organosys Innovex Sun Pharma Baxter India Pvt Ltd Reliance Life Sciences Stride Arcolab Ltd Dr. Reddy's Lab Rexin pharmaceutical Harihar Fertilizers UTI Bank Ltd. CRRI Charak Pharmaceuticals

12. QUOTES Today’s concept of quality control is founded on the belief that experts who are more highly educated, more mechanically oriented/trained and more able to support continuous quality Control tasks—or in other words-tasks that are performed throughout the creation of the product itself, will convert final quality controls to continuous Quality Controls. SOURCE: EZINE ARTICLES By: Marci .L.Crane Education, the "mechanics of thinking" and the FDA's support of PAT (Process analysis technology) should all be information that Pharmaceutical companies take seriously as they encourage the use of continuous Processing and more effective quality control. SOURCE: EZINE ARTICLES By: Marci.L.Crane

13. DOWNLOAD THE APPLICATION FORM CLICK HERE www.bii.in/pharma/pharma_qaqc_prospectus.asp Submission of Application Form along with the demand draft of Rs.10300 /- in favor of Bioinformatics Institute of India, payable at Delhi / Noida. Enclosures (Mark sheet – 10th, 10+2, graduation / Post –graduation 1 Photographs) Admission Procedure

14. PROGRAM DURATION Industry program in Pharma Quality Assurance and Quality Control is 12 months distance learning program. FEE STRUCTURE Fee structure for 12 months is 10,000 Rs

15. PROGRAM AWARD After completion of the Program the participant will be provided with the following certificate (Sample)

16. BIOINFORMATICS INSTITUTE OF INDIA For more details of BII you can visit on following links www.bii.in www.biinoida.blogspot.com www.biionline.org http://www.bii.in/page/academic_program/Advance_Program_crct_prospectus.asp http://www.bii.in/page/academic_program/Dual_Program_prospectus.asp http://www.bii.in/page/academic_program/index_old.asp http://www.bii.in/page/academic_program/index_BINC.asp http://www.bii.in/page/academic_program/project_training_index.asp http://www.bii.in/page/academic_program/solution_corporates_institution_index.asp

17. THANK YOU For Further Details & Enquiries Contact: Bioinformatics Institute of India C-56A / 28, Sector – 62 Noida – 2010301, U.P Tel: 0120-4320801/02 Mobile: 9818473366, 9810535368 Email: info@bii.in Visit: www.bii.in