Basic GMP and Validation
Event
In Navi Mumbai
Description
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Type
Event
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Level
Intermediate
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Location
Navi mumbai
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Class hours
16h
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Duration
2 Days
Course Contents:
Day 1:
- What is GMP & why this is required? History
- Premises – Best utilization of Resources
- Sanitation & hygiene – Cross contamination & Microbiological aspect
- Documentation – Optimizing in advantage
- Inspection – Preparation, day plan & Reply
Day 2
- Qualification process- DQ, IQ, OQ, PQ
- Process Validation – Retrospective, prospective , concurrent
- Method Validation – Instrumental, Microbiological
- Cleaning Validation – process & Critical aspect
- Water, Air Validation – Physical & microbiological
Facilities
Location
Start date
Start date
About this course
Our Learn GMP – Basics & Validation workshop is aimed principally at anyone who is working in pharma industry, cosmetic or allied Industry. All Employees from Quality Assurance, Quality Control, Engineering, Production, stores, Engineering and Process Improvement personnel will be benefited from this workshop.
Reviews
Subjects
- Basic
- GMP
- Learn GMP
- Validation
- Sanitation
- Hygiene
- Process and critical aspects
- Validations
- Premises
- Documentation
- Inspection
- DQ
- IQ
- OQ
- PQ
- Retrospective
- Prospective
- Concurrent
Teachers and trainers (1)
Vishalakshi Naik
Consultant & Trainer in GMP, GLP, GCP, and External Auditor.
Managing Proprietary Consultancy Firm “Quality Solutions”. Founder Director of Consultancy & Training company "Center for Clinical Research and Training Pvt. Ltd." & Experience in the Pharmaceutical, Food & Cosmetic Industry since 1988. Managed the activities of NGO in Administering Manufacturing & Distributing over 300 Spiritual / educational books in all over India. Managed to Co-ordinate & Set MIS (Management Information System) for Spiritual & Social Welfare NGO related activities in India & Abroad like collecting donations, distributing material for the cause of NGO.
Course programme
Basic GMP is a habit which we need to inculcate in the culture of every organization & Validation is the soul of GMP. Hence this Learn GMP Series - Workshop 2, is developed on demand from industry after our 1st Learn GMP workshop on Learn GMP series. All will agree that habits cannot be formed in a day or two; here we will give few very important techniques to develop such habits. We will be focusing equally on developing such precious habits in your talent pool, Such GMP empowered talent in organisation will be benefited by saving resources. Our Focus will be always on LEARNING, during and after the workshop. Systematic consistent, compliant up-gradation, in this GMP culture will keep winning great business for you in this competitive market.
Our interactive Learn GMP – Basic & Validation Workshop will be take delegates through Basics of GMP and 2nd day we will be focusing on Validation. During the learning process, there will be about 10 hands-on assignments, which will really heal every Learner to understand the subject thoroughly. Soft copy of all different country guidelines will be given to every delegate.
Basic GMP and Validation