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Work Integrated Learning Programmes

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M.Tech.PHARMACEUTICALOPERATIONS ANDMANAGEMENT

Pharmaceutical manufacturing is a unique interdisciplinary field wherein the employees need to know the basics of drugs and pharmaceuticals apart from the usual engineering and process knowledge that is required for any kind of manufacturing. Being a highly regulated field, appropriate knowledge of regulatory guidelines is essential. The employees usually know about one or at most two of the above critical functionalities based upon their background. The four-semester M.Tech. Pharmaceutical Operations & Management programme has been designed in such a way so that the executives have a proper grasp of all the essential aspects of drugs, quality, regulatory, manufacturing, management and engineering that are important in pharmaceutical manufacturing.

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PROGRAMME HIGHLIGHTS

• Enables students to gain an overall perspective in the domains of pharmaceuticals, manufacturing, process engineering, regulatory and management simultaneously

• Provides insights into the manufacturing management

• Exhaustive exposure to latest regulatory guidelines like Quality by Design (QbD ) and Design of Experiments (DoE)

• Well-defined work integrated exercises to transform classroom learning into practice

• Guided internship project to for execution of knowledge gained

PROGRAMME OBJECTIVES

Graduates of the M.Tech. Pharmaceutical Operations and Management will be able to:

• Apply knowledge in operations and administration activities of pharmaceutical industry

• Get an idea of various aspects of pharmaceutical operations and management with emphasis on technology innovation, new products planning, strategic considerations and IPR

• Understand and apply criticalities in scale-up

• Understand and apply concepts of DoE in all kind of experiments

• Develop scientific and critical thinking skills

• Understand the impact of current technological solutions in a global, economic, environmental and societal context

M.Tech.PHARMACEUTICALOPERATIONS ANDMANAGEMENT

FEE STRUCTURE

The following fees schedule is applicable for candidates seeking new admission during the academic year 2016-17.

Application Fees (one time) : INR 1,500

Admission Fees (one time) : INR 15,000

Semester Fees (per semester) : INR 45,750

LEARNING OUTCOMES

Graduates of the M.Tech Pharmaceutical Operations and Management will be able to:

• Interpret and implement management information system in their team

• Develop and interpret supply chain mechanism in the pharmaceutical industry

• Apply ICH guidelines and other regulatory guidelines in pharmaceutical manufacturing to get quality product

• Acquire expertise in QbD and DoE resulting in application of concepts in new product and process development

• Understand the basics of pharmaceutical operations and relate to the practical concerns

• Understand the requirements and implications of advanced technology in pharmaceuticals for product development

• Acquire basic foundation on problem-solving skills related to pharmaceutical operations and management

ELIGIBILITYEmployed professionals holding BDS/B.Pharma./B.Tech./BE/MBBS/BVSC/M.Pharma./M.Sc./M.Tech./MS/MVSC/Integrated First Degree from BITS Pilani or its equivalent, with one year of relevant work experience.

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SEMESTER-WISE PROGRAMME STRUCTURE

Participants need to take 12 courses and complete one project during the programme.

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First SemesterPharmaceutical Administration and ManagementProduction and Operations ManagementQuality Assurance and Regulatory AffairsProject Management

Second SemesterAdvanced Pharmaceutical TechnologyIntellectual Property Rights & PharmaceuticalsSupply Chain ManagementStrategic Management & Business policy

Third SemesterHuman Resource ManagementPharmaceutical Process Development and Scale-upElective 1Elective 2

Fourth SemesterDissertation

HOW TO APPLY

1. Click here to go to the BITS Pilani Application Center.

Create your login ID at the Application Center by entering your unique Email ID and create a password of your choice.

Once your login ID has been created, you can access the online Application Center anytime using your email ID and password.

2. Once you have logged in, you will see a screen showing 4 essential steps to be completed to apply for the programme of your choice.

3. Begin by clicking on Step 1 - ‘Fill/Edit and Submit Application Form’.

This will enable you to select the programme of your choice available at your location. After you have chosen your programme, you will be asked to fill your details in an online form.

You must fill all details and press ‘Submit’ button given at the bottom of the form.

4. Take the next step by clicking on Step 2 - 'Download Application PDF Copy’.

This will download a pdf copy of the application form on your computer.

5. Now, click on Step 3 - 'Pay Application Fee’ to pay INR 1,500/- using Netbanking/Debit Card/ Credit Card.

6. Take a printout of the downloaded Application Form and note down the Application Form Number that appear on the top-right corner of the first page. This Application Form Number should be referred in all future correspondence with BITS Pilani.

7. In the printout of the downloaded Application Form, you will notice on page no. 3 a section called the Employer Consent Form. Complete the Employer Consent Form. This form needs to be signed and stamped by your organisation’s HR or any other authorised signatory of the company.

Further on page no. 4 of the printed Application Form is a section called the Mentor Consent Form. You must find a senior person from your employing organisation who is willing to become your mentor. The Mentor Consent Form needs to be signed by the mentor.

The role of a mentor: A mentor is a senior officer of the student-employee who has been nominated by his employing organisation or is a person in a senior position willing to undertake and discharge the academic responsibilities on his own volition. It is expected of the mentor to possess adequate qualifications to guide the student. Typically for the B.S. programmes, mentor is expected to have minimum educational qualification of the level of Integrated First Degree of BITS or its equivalent such as B.E./BITS B.S./B.Tech./M.Sc./A.M.I.E. etc. and for the M.S./M.Phil. programmes of the level of Higher Degree of BITS or its equivalent such as M.E./M.S./M.Tech./ M.Phil./M.D. etc. However, senior professionals holding a First Degree of BITS or its equivalent such as B.E./M.Sc./M.B.A./M.C.A./M.B.B.S. etc. and having a minimum of 5-years of relevant work experience, may also be proposed as mentors. Preference will be given to applicants having a suitable mentor from the same employing organisation. Wherever the proposed mentor is not from the same employing organisation as that of the applicant, a supporting document giving justification for the same should be duly forwarded by the applicant's employer.

The mentor will assist the course instructors in terms of the following:

• Achieving the set of academic objectives specified by the instructors

• Verifying if a student is indeed adhering to the plan of study given in the handout

• Monitoring involvement of the student in self-study, time planning, understanding of concepts and their use, developing self-reliant articulation, awareness of and enthusiasm for new pedagogy, responsibility to meet deadlines, develops familiarity with the library, etc.

• Conducting certain evaluation components like seminar, assignment, project, case study, etc.

8. Further on page no. 5 of the downloaded Application Form is a Checklist of Enclosures/ Attachments.

a. Make photocopies of the documents mentioned in this Checklist

b. Get these photocopies attested by your organisation’s HR, or a Gazetted Officer

9. Finally, click on Step 4 - 'Upload & Submit All Required Documents’.

This will allow you to upload one-by-one the printed Application Form, Mentor Consent Form, Employer Consent Form, and all mandatory supporting documents and complete the application process.

10. Upon receipt of your Application Form and all other enclosures, the Admissions Cell will scrutinise them for completeness, accuracy and eligibility.

ElectivesAdvanced Physical PharmaceuticsDosage Form DesignManufacturing Organisation and ManagementTQM Tools and Techniques

Apply now

HOW TO APPLY

1. Click here to go to the BITS Pilani Application Center.

Create your login ID at the Application Center by entering your unique Email ID and create a password of your choice.

Once your login ID has been created, you can access the online Application Center anytime using your email ID and password.

2. Once you have logged in, you will see a screen showing 4 essential steps to be completed to apply for the programme of your choice.

3. Begin by clicking on Step 1 - ‘Fill/Edit and Submit Application Form’.

This will enable you to select the programme of your choice available at your location. After you have chosen your programme, you will be asked to fill your details in an online form.

You must fill all details and press ‘Submit’ button given at the bottom of the form.

4. Take the next step by clicking on Step 2 - 'Download Application PDF Copy’.

This will download a pdf copy of the application form on your computer.

5. Now, click on Step 3 - 'Pay Application Fee’ to pay INR 1,500/- using Netbanking/Debit Card/ Credit Card.

6. Take a printout of the downloaded Application Form and note down the Application Form Number that appear on the top-right corner of the first page. This Application Form Number should be referred in all future correspondence with BITS Pilani.

7. In the printout of the downloaded Application Form, you will notice on page no. 3 a section called the Employer Consent Form. Complete the Employer Consent Form. This form needs to be signed and stamped by your organisation’s HR or any other authorised signatory of the company.

Further on page no. 4 of the printed Application Form is a section called the Mentor Consent Form. You must find a senior person from your employing organisation who is willing to become your mentor. The Mentor Consent Form needs to be signed by the mentor.

The role of a mentor: A mentor is a senior officer of the student-employee who has been nominated by his employing organisation or is a person in a senior position willing to undertake and discharge the academic responsibilities on his own volition. It is expected of the mentor to possess adequate qualifications to guide the student. Typically for the B.S. programmes, mentor is expected to have minimum educational qualification of the level of Integrated First Degree of BITS or its equivalent such as B.E./BITS B.S./B.Tech./M.Sc./A.M.I.E. etc. and for the M.S./M.Phil. programmes of the level of Higher Degree of BITS or its equivalent such as M.E./M.S./M.Tech./ M.Phil./M.D. etc. However, senior professionals holding a First Degree of BITS or its equivalent such as B.E./M.Sc./M.B.A./M.C.A./M.B.B.S. etc. and having a minimum of 5-years of relevant work experience, may also be proposed as mentors. Preference will be given to applicants having a suitable mentor from the same employing organisation. Wherever the proposed mentor is not from the same employing organisation as that of the applicant, a supporting document giving justification for the same should be duly forwarded by the applicant's employer.

The mentor will assist the course instructors in terms of the following:

• Achieving the set of academic objectives specified by the instructors

• Verifying if a student is indeed adhering to the plan of study given in the handout

• Monitoring involvement of the student in self-study, time planning, understanding of concepts and their use, developing self-reliant articulation, awareness of and enthusiasm for new pedagogy, responsibility to meet deadlines, develops familiarity with the library, etc.

• Conducting certain evaluation components like seminar, assignment, project, case study, etc.

8. Further on page no. 5 of the downloaded Application Form is a Checklist of Enclosures/ Attachments.

a. Make photocopies of the documents mentioned in this Checklist

b. Get these photocopies attested by your organisation’s HR, or a Gazetted Officer

9. Finally, click on Step 4 - 'Upload & Submit All Required Documents’.

This will allow you to upload one-by-one the printed Application Form, Mentor Consent Form, Employer Consent Form, and all mandatory supporting documents and complete the application process.

10. Upon receipt of your Application Form and all other enclosures, the Admissions Cell will scrutinise them for completeness, accuracy and eligibility.

CURRICULUM DETAILS

The programme covers courses in the area of management, apart from manufacturing or regulatory. The programme has been designed in such a way that the executives would have appropriate awareness of all the essential aspects of regulatory, manufacturing, management and engineering that are important in pharmaceutical manufacturing. The programme culminates in a rigorous project that requires the integration and application of concepts learnt throughout the programme.

• Supply Chain Management

• Human Resource Management

• Project Management

Foundation in Execution and Management

These courses are essential for a sound execution of the plans. The students learn the general principles and best practices behind execution and management through a series of lectures supported by case studies. The well-structured work-integrated learning exercises provide additional learning opportunities to the students.

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• Quality Assurance and Regulatory Affairs

• TQM Tools and Techniques

• Intellectual Property Rights & Pharmaceuticals

Quality and Regulatory

These courses basically concentrate on regulatory aspect of pharmaceutical manufacturing. 21CFR, process and equipment validation are dealt with at length. SUPAC guidelines for various delivery systems are covered. IPR related issues are adequately addressed and various concepts of quality like QC, QA, TQM and their importance in process control is emphasized upon. Process capability index calculation is also covered at length.

• Advanced Pharmaceutical Technology

• Pharmaceutical Administration and Management

• Advanced Physical Pharmaceutics Dosage Form Design

Pharmaceutical Technology

These are a set of courses wherein design of conventional and novel formulations for delivery of drugs is covered. The newer technologies used in design of drug delivery systems is emphasized upon. Various quality control parameters of dosage forms are covered. Concepts of QbD are dealt with at length so that quality can be integrated in product and process at design phase. Identification, control and optimization of process parameters affecting critical quality attributes of product using DoE is discussed.

• Pharmaceutical Process Development and Scale-up

• Production and Operations Management

• Manufacturing Organisation and Management

Process Engineering and Manufacturing Management

These set of courses deal with problems related to scaling up pilot batch to exhibit batches. Scale-up techniques of both formulations and bulk drug manufacturing is covered. Manufacturing organisation and operation management is also dealt with at length.

Dissertation

Project

The programme culminates with the successful completion of a semester-long project drawn from the workplace; applying the concepts learnt throughout the programme. The project is periodically reviewed by the organisation mentor and the assigned instructor.