Process Validation in Nutraceuticals

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Course Code: NPD201906
Courses Name: Process Validation in Nutraceuticals
Name of HOD – Shrikant Charde
Designation of HOD – General Manager, Regulatory and International Business Esperer Onco Nutrition, Dubai, UAE

About the course : The method validation starts only when the method parameters have been finalized as part of the method development. In majority of cases, a validation protocol will be written, and agreed upon by the relevant information of (analysis, laboratory results, QC/QA reports, clients etc.). This course covers the areas of validation like Equipment/ Instrument Validation, Manufacturing Process Validation, Analytical Method Development and Validation. In addition, the course identifies the long list of activities required to validate Nutraceutical & Pharmaceutical processes.

Course Status :	Admissions open
No. of Modules	14
Course Type :	Elective
Duration :	14 weeks
Category :	Food Engineering Food Technology, Pharmaceuticals and Nutraceuticals
Credit Points :	2
Level :	Postgraduate/ Undergraduate

Mode of Study: The Course curriculum will be delivered through automated online lectures, and case studies on the Nutrify Today Academy platform. Grading will be based on a series of individual assignments and a final test on completion of all the modules.

Learning Outcome:

- Help manufacturers gain awareness of quality requirements regarding validation.
- to understand and demonstrate compliance with validation requirements
- This programme targets Quality, Product Development and Manufacturing personnel involved in process validation, Regulatory Affairs Managers and auditors of manufacturing firms (internal and external).
- To reduce development time with better understanding of validation
- Faster market access with more compliant products, Increase sales and customer satisfaction strategies.

Week 1	Introduction to Validation Concepts of QC, QA, TQM and important role of validation
Week 2	Equipment/ Instrument Validation I Steps in equipment/ instrument validation
Week 3	Equipment/ Instrument Validation II Example of validation of commonly used equipment
Week 4	Equipment/ Instrument Validation III Example of validation of commonly used analytical instruments
Week 5	Manufacturing Process Validation I Difference between process and equipment validation, Importance of process validation, Types of process validation
Week 6	Manufacturing Process Validation II Steps in process validation (process control charts, Ishikawa Diagrams, Pareto’s Principle)
Week 7	Manufacturing Process Validation III Steps in process validation (process control charts, Ishikawa Diagrams, Pareto’s Principle)
Week 8	Manufacturing Process Validation IV Example of process validation and arriving at Batch Manufacturing Record using process validation data
Week 9	Manufacturing Process Validation V Sampling during validation and routine analysis
Week 10	Analytical Method Development and Validation I Unique challenges in development and validation of analytical methods for nutraceuticals
Week 11	Analytical Method Development and Validation II Approaches to analytical method development in Nutraceuticals, types of validation, types of analytical methods
Week 12	Analytical Method Development and Validation III Definition, importance, and calculation of analytical method validation parameters
Week 13	Analytical Method Development and Validation IV Definition, importance, and calculation of analytical method validation parameters
Week 14	Analytical Method Development and Validation III Example of analytical validation and calculation of parameters

What is the admissions process for the programme?

The admissions process is completely online and is customised as per your educational and professional profile. Following are the key steps in the application process:

Step 1: Register yourself on to Nutrify Today platform by clicking on https://nutrifytoday.net/ and create your individual profile, building your CV onto the platform.
Step 2: Select up skill > Academy > Master classes
Step 3: Select the course and make the payment, receive immediate access to the prep content and begin your Nutrify Today Academy journey.

Benefits:

100% online
This Course Plus the Full Specialization
Shareable Certificates
Self-Paced Learning Option
Course Videos & Readings

Intended audience : Any current Masters pursing students or professionals of Food technology, Pharmaceuticals and Nutraceuticals streams Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc.

Any Science Graduate, Food Engineering,
Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology, B.Pharmacy/ M. Pharmacy / Pharmaceutical Sciences/Chemistry / Biostatistics / Bioinformatics

Criteria to get the Certificate : Exam score = 80% of the proctored certification exam score out of 100

Certificate will have your name, photograph and the score in the final exam with the breakup
Only the e-certificate will be made available. Hard copies will not be dispatched.

Internship opportunities and Nutrify Today industrial connects for job opportunities in the field of R & D, Regulatory, and Manufacturing departments of Nutraceuticals, Pharmaceuticals and Food Technology.