Syngene Ramaiah Certificate Program in Sterile Manufacturing

Biocon Academy partners with Syngene and MS Ramaiah College of Arts, Science & Commerce to offer this 16-week intense course aimed at helping the graduates of Pharmacy, Microbiology, Biotechnology & Biochemistry

background to gain adequate background on the industry, practices and procedures including unit operations and then land on operational functions of parenteral medicines manufacturing.

Program Highlights

The 16 weeks Syngene Ramaiah Certificate Program in Sterile Manufacturing aims at providing specific job skills with emphasis on Regulatory requirements, Manufacturing Processes, Sterilization and Quality Management Systems background to help the participants to find meaningful employment in the sterilization function and start delivering with very less need for training.

Career Opportunities

There is a significant demand for skilled personals with appropriate education background and training in sterilization practices. Understanding the basic principles of Manufacturing Processes, Sterilization and Quality Management Systems background will help to get an entry to the industry.

Customised Curriculum

With a customised curriculum, modules encompass vast topics like Introduction to Pharma Industry, Quality Management Systems, General Discipline at Manufacturing Sites & Manufacturing Processes. This course is aimed at providing high end, specific training to the Graduate microbiologists, biotechnologists, and pharmacists, to make them readily employable and reduce the time taken by the industry to train them.

Key Differentiators

Enhancing the employability of under graduates
Detailed overview of Parenteral manufacturing unit operation
Exposure to Sterile operations
One-week Hands-on training
Intensive Industrial Visits
Insights to Regulatory backdrop
Job-ready skills with 100% Placement Assistance

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About the Course

Introduction to Pharma Industry

Overview of Pharma Industry
Understanding APIs, Excipients, Formulations, Sterile, Non-sterile
How Medicines cure diseases
Expiry, Licenses, Precautions from Labels
Biological Products & Markets: Small molecules and difference between SM and LM and Biologics
Life Cycle of a Drug Product

Quality Management Systems

Good Manufacturing Practices
Good Documentation Practices: ALCOA++, Examples for each component
Regulatory Framework

General Discipline at Manufacturing Sites

Do’s & Don’t While in Manufacturing Premises
Entry & Exit Procedures
Basics of EHS

Manufacturing Processes

Parenteral Preparation Flow
Equipment
Documentation
Validation
Engineering
Utilities
Microbiology
Cleanroom Design
Stability, Storage and Distribution

Sterilization I - Terminal Sterilization

Types of Sterilization and Sterilization decision tree
Types of autoclave
Autoclave: Principles and operations- D, Z, F0 Values
Autoclave cycle development
Autoclave cycle validation
Introduction to Gamma irradiation
Validation of Gamma irradiation
Pyrogens and depyrogenation through dry heat
Gaseous and Radiation based sterilization

Sterilization II - Aseptic Processing

Introduction to Biopharmaceutical Manufacturing
Introduction to formulation and mixing technologies
Filter sterilization- Types of filters, Filter selection
Filtration train – design and volume maximization
Filter integrity testing
Filter validation
Aseptic Process Validation (media fill) Emphasis on aseptic techniques and behaviour (PDA Tech Report 26)

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Eligibility Criteria

Education Qualification

B Pharm
BSc./MSc., Microbiology/Biotechnology/Biochemistry

Minimum CGPA/Percentage Required

CGPA: 6 and above on a scale of 10
Percentage: 60% and above

Break in education of 1 year and less from HSC/PUC to the current highest degree, and break in career for up to a year is permissible.

Adherence to the eligibility criteria is mandatory. Kindly note the same and apply only if you fit the desired eligibility criteria as mentioned above.

Program Fee & Scholarship

The Syngene Merit Scholarship of 60%-75% of the program cost offered to all selected students will enable them to pursue this one-of-its-kind program at an affordable cost.

Student Share: INR 50,000 + 18% GST

Student Facilities

At Biocon Academy, the students have to go through a rigorous curriculum so that by the time their course comes to an end, they are industry-ready and sought after by multiple companies. We encourage them to remain focussed and excel in everything they do. For the benefit of the students, we assist them with a couple of facilities to ensure they just focus on the curriculum.

Industry Placements

At Biocon Academy, we provide 100% interview opportunities to all our students. Ever since inception, Biocon Academy has witnessed 100% placement record in all the courses and batches with students being selected for leading pharma and biopharma companies and startups.

Transport

We understand that commuting to different locations for industry training can get challenging especially when students have to arrange for it themselves. Therefore, students are provided with group transport facilities from Biocon Academy to different training locations and then back to the Academy.

Meals

Throughout the course, Biocon Academy students are provided with nutritious and sumptuous lunch at the Biocon Academy premises. They also have access to beverage vending machines for tea, coffee, and milk throughout the day.

Accommodation

Students come to pursue studies at Biocon Academy from different parts of the country and upon their request, we provide options of nearby paying guests and hostel accommodations based on the previous student choices. Kindly note that students and their parents/guardians alone are responsible for any decision taken regarding their stay.

Your Career Starts Here!

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Syngene Ramaiah Certificate Program in Sterile Manufacturing