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Program Overview

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 indepth and latest knowledge required for a Pharma Quality professional.

The program covers topics like Quality Assurance and Control in Pharma Industry, WHO Good Manufacturing Practices, Inspection, Hazard and Risk Analysis, International Trade in Pharmaceuticals , Quality Standards, Quality Management, Auditing, Statistical Quality Control and Biostatistics, the ICH Guidelines, Indian Guidelines on GMP, Product Assessment and Registration, WHO Certification, Pharma Regulation Practices and Procedures etc. There is a good demand of Quality Control Officers all over the world. The program is conducted through Distance Participation.

Program Objectives

• 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.

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 self analysis work books to BII .
  • Interacting with other participating members and organizations through BII Blog at http://www.biinoida.blogspot.com
  • Spreading awareness about Pharma QA & QC area with others through knowledge sharing.
  • Time Bound Completion of the Program
  • Receiving Citation & Experience Certificate from BII about objectives achieved during the program.

Program Areas

• Module I : Quality Assurance in Pharma Industry-I
  • National Drug Regulation.
  • Product Assessment and Registration
  • Distribution
  • The International Pharmacopia
  • Basic Test Program
  • Laboratory Services
  • International Trade in Pharmaceuticals
  • Counterfeit Drugs
  • Training Program
• Module II : Quality Assurance in Pharma Industry-II (WHO Perspective)
  • WHO GMP: Main Principles for Pharmaceutical Products
  • Starting Materials
  • Specific Pharmaceutical Products
  • Inspection
  • Hazard and Risk Analysis
• Module III : Good Manufacturing Practices, Quality Assurance and Regulation
  • Basis of Good Manufacturing Practices, Quality Assurance and Regulation
  • Overview of Good Manufacturing Practices
  • The ICH Guidelines
  • The Indian Guidelines on GMP
  • Quality Assurance in Pharmaceutical Industry
  • Quality Control for Pharmaceutical Laboratories
• Module IV : Quality Assurance and Control
  • Quality Standards
  • ISO 13485:2003-An Introduction
  • Format of ISO 13485:2003 standards
  • Quality Management Principles
  • Auditing by FDA
• Module V : Pharma Regulation Practices & Procedures
  • Pharma Regulatory Affairs: Objectives and Issues
  • Drug Regulatory Authorities
  • Overview of Good Manufacturing Practices
  • Regulation of Pharmaceutical Devices
  • Regulations on Alternative System of Medicine
  • Bioethics
  • Drug Policy in India
  • Regulatory Affairs Profession
• Module VI : Statistical Quality Control and Biostatistics
  • Statistical Quality Control
  • Data Presentation
  • Data Characteristics: Descriptive Summary Statistics
  • Probability: Basic Concepts
  • Basic Probability Distributions
  • Sampling
  • Estimation
  • Hypothesis Testing
  • Applications of Hypothesis Testing
  • Categorical Data Analysis and Analysis of Variance
  • Simple Linear Regression and Correlation
  • Multiple Regression
  • Hidden Markov Models: The Theory
  • Vital Statistics
• Module VII : Research Study

These modules cover important concepts like:

These modules cover important concepts like-Quality Assurance, Quality Control, Inspection, Knowledge in Quality Assurance and Standard Operating Procedures (SOP), All Current SOPs, Writing SOP's, Proficient Testing Procedures to Generate Monthly Report of Quality Control, Qualification, Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Validation Protocol and Report, Change Control, Deviation, Incidence Notification, Training, BMR and BPR Issuance Software, Processing and Analysis of Samples, Specific Pharmaceutical Products, Registration, Basics of Good Manufacturing Practices, Quality Assurance and Regulation, ICH Guidelines, Overview of GMP, Indian Guidelines on GMP, Quality Standards, Quality Management Principles, Auditing by FDA, ISO Standards, Exposure to USFDA/cGMP/GLP, Drug Regulatory Authorities, Quality Assurance, Regulatory and Documentation Activities for ANDA including Working Knowledge of SOP Preparation, Calibration and Qualification, Documentation, Validations , Training and Conducting Internal Audits, Knowledge of Pharmaceutical Regulations , cGMP/GLP and Pharmaceuticals Unit Operations, Regulations of Pharmaceutical Devices, Regulations on Alternative System of Medicine, International Trade in Pharmaceuticals, Counterfeit Drugs, Quality Analyst , Laboratory Services , All Validation Activities such as Process, Equipment, System, Cleaning, FDA Related Activities, Handling Latest Analytical Instruments like HPLC, GC, FTIR, UV-VIS Dissolution, Documentation Skills, Format of ISO 13485:2003 Standards , Data Presentation , Probability , Analysis of Variance , Clinical Trial Regulation , Clinical Pharmacy , Time to Time Facility, Process and System Technical Up gradation as per the Current Regulatory Guidelines , GMP Certification ,Data Characteristics, Basic Test Program, Hypothesis Testing, Drug Laws, Bioethics, Drug Policy in India, Regulatory Affairs Profession, Statistical Quality Control, Sampling, Estimation, International Pharmacopoeia .

Deliverables

Program Deliverables include:
Training Kits comprising of Reference Materials and Free Lecture CDs, Support via Internet, Email and Telephone and Information exchange via BII Blog.

BII Lecture CDs

BII Courseware

How To Join

In order to join BII Industry Program on Program on Pharma Quality Assurance and Control the prospective participant has to submit the necessary form. Down Load Now

BII Blog

BII Blog - is an open interactive knowledge platform for you. It is meant to be a platform "Of the Participants, for the Participants by BII". BII Blog will provide the following facilities:

• Knowledge interchange and exchange among the users.
• Web based resources.
• Information sharing on jobs, events etc.
• Other activities of mutual interest among the users.

So, through this Synchronous Discussions - computer mediated communication (CMC) participants are able to communicate with other participants of the Institute to share news, views, comments and opportunities in the domain area.

BII Blog is available on website. The link is http://www.biinoida.blogspot.com. All program participants are provided access to BII Blog.

Eligibility

The eligibilty for the training 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 10000 (for participants based in India / USD 750 ( 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 12 months.

Evaluation

At the end of the duration of a program, participants go through a well defined evaluation process which is held on an all India basis.

Pharma Quality Assurance and Quality Control Industry

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 health care where quality assessment is a relatively new idea.

Career in Pharma Quality Assurance and Quality Control

• Quality assurance technicians or analysts
• Quality assurance or control managers
• Quality Researcher
• Quality Assurance Engineer
• Quality Assistant

Some of our students are associated with the following renowned companies

Company Name	Company Name
Panacea Biotech Ltd	Elder Pharma Ltd
Glaxosmithkline	Lupin Ltd.
A.I.I.M.S.	Bio-Rad Laboratories (I) Pvt. Ltd.
Ranbaxy Lab Ltd.	Aurobindo Pharma Ltd.
Cadila Pharmaceuticals Ltd.	Pfizer Ltd
GSK India	Shasun Chemicals&Drugs Ltd.
L&T Information Tech. Ltd.	Polaris Software Lab Ltd.
Wipro Technologies	Infosys Technologies Ltd.
ANR Right Gen Technology	Deptt. Of Plant Molecular Biology Univ. Of Delhi
Merck India	Charak Pharmaceuticals
CRRI	UTI Bank Ltd.
GVM College of Pharmacy	Harihar Fertilizers
Rexin pharmaceutical	Uttaranchal Institute of Technology
Crompton Greaves Ltd.	Sesa Goa Ltd.
DAV College	BBMB Hospital Chandigarh
UV Vitamins	Dr. Reddy's Lab
Stride Arcolab Ltd	MSPL Ltd.
Vaidik Remedies, Nagpur	Cosme Pharma
Reliance Life Sciences	Clonegen Biotech
Baxter India Pvt Ltd	Sun Pharma
Innovex	Jubliant Organosys
Trabsegene Biotech Ltd	Cipla Ltd.

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For further details and enquiries

India	Overseas
Program Co-ordinator Industry Program in Pharma Quality Assurance and Quality Control Bioinformatics Institute of India C-56 A/28, Sector - 62 Noida - 201301, UP(INDIA) Tel : 0120 - 4320801/02 Mob : 09810535368	Dr. Kumud Sarin INTERNATIONAL ACADEMIC COUNSELLOR +91-9811420055
E-mail : info@bioinformaticscentre.org	Email: global@bii.in

	Application Form