Plant Audit and Product Registration in Nutraceuticals

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Course Code: NPD201907
Courses Name: Plant Audit and Product Registration in Nutraceuticals
Name of HOD – Shrikant Charde
Designation of HOD – General Manager, Regulatory and International Business Esperer Onco Nutrition, Dubai, UAE

About the course : This course provides an intensive conceptual and applied introduction to auditing in the nutraceutical and pharmaceutical industry. It focuses on concepts and applications related risk management auditors professional responsibilities as well as major facts of the audit process including risk assessment and audit reporting, engaging in critical thinking and thoughtful communication about audit decision environments, decision processes, and deliverables. Additionally, this course helps to understand the macro-level learning objectives in each of the module throughout the course.

This course anticipates covering the following points:

Understand the concepts and principles of risk management and the steps to manage portfolio credit risks.
Use statistical models to measure risk associated with different types of investments.
How to build an operational risk assessment program in an organization.
Differentiate between Nutraceutical and Pharmaceutical audits
It focuses on a conceptual framework that is applied by audit professionals to assess, evaluate, and manage audit risks and evidence.

This course helps the students who are pursuing life science courses and working class professionals to upgrade their knowledge on the ongoing audit procedures and documentation.

Course Status :	Admissions open
No. of Modules	12
Course Type :	Elective
Duration :	12 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 Difference in regulatory guidance for pharmaceuticals and nutraceuticals
Week 2	Registration of Manufacturing Plant Brief overview of guidelines followed globally
Week 3	Audit of Manufacturing Plant Types of audit, processes to be followed
Week 4	Good Manufacturing Practices in Nutraceuticals I & II Building and environment Control
Week 5	Good Manufacturing Practices in Nutraceuticals III Manpower, raw material(actives, excipients, packaging materials) control
Week 6	Good Manufacturing Practices in Nutraceuticals IV Equipment and process control
Week 7	Good Manufacturing Practices in Nutraceuticals V Analytical control
Week 8	Good Manufacturing Practices in Nutraceuticals VI Warehousing and distribution control
Week 9	Good Manufacturing Practices in Nutraceuticals VII Returned and salvaged drug products
Week 10	Preparing for Audit Team formation, checklist preparation, document readiness
Week 11	Registration of Nutraceutical Products 1 Registration guidance, classification and categories in USA and Brazil Registration guidance, classification and categories in China, Philippines, Vietnam, Cambodia, Singapore
Week 12	Registration of Nutraceutical Products 2 Registration guidance, classification and categories in UK, Europe and CIS Registration guidance, classification and categories in Japan, Australia, New Zealand

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.

Any Science Graduate, Food Engineering

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.