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Basic Good Manufacturing Practices (GMP): Online Interactive Learning Program by Sunil Singh

Description

In this program, you are going to learn about Pharmaceutical Industry GMP (Good Manufacturing Practices). The 8 modules (14 hours duration with 5 Assessments & 4 Assignments) of this program contains in-depth learnings about Pharma Industry, Regulations & Acts of Pharma Industry, Organization & Personnel, Premises and Equipment – API/ OSD, Material Management, Production and Process Control – API/ OSD, Quality Control Laboratory & much more. This program is recommended for both working professionals & freshers who want to join Pharma Quality Assurance department. You will be able to crack the interviews for the entry level as well as for the next level of your career after going through this detailed program.

Duration: 14 hours

Includes: 8 Modules, 5 Assessments & 4 Assignments

Mode of Learning: Online Live Interactive Sessions

Language: As per need of candidate (Hindi/English/Hinglish – a mix of English+Hindi)

Training Schedule

Module NameLearning ContentDuration (in minutes)AssessmentAssignment
Module 1: Introduction to Pharma Industry5 Topics90NoNo
Module 2: Regulations and Acts prevailing in Pharma Industry5 Topics90NoNo
Module 3: Organizational and Personnel7 Topics90NoNo
Module 4: Pharmaceutical Quality System9 Topics120YesNo
Module 5: Premises and Equipment – API/ OSD8 Topics120YesYes
Module 6: Material Management – Warehouse6 Topics120YesYes
Module 7: Production and Process Control – API/ OSD11 Topics120YesYes
Module 8: Quality Control Laboratory11 Topics120YesYes
Total62870 minutes (14 hours)54

About the instructors

Sunil Singh has given 25 years of his life perfecting the art of upholding the highest possible standards of medicine quality. Graduating with M.Sc. in Organic Chemistry in 1994 from Banaras Hindu University (BHU), he has discharged numerous responsibilities during his career like handling of regulatory and customer audits, people development through training and demonstration, implementation and monitoring of Quality Systems based on FDA’s six quality systems approach, preparation of corporate guidelines for implementation across other sites in the organisation, monitoring the stability of API and DF, monitoring of Quality Systems through Quality Metrics as per new FDA/ MHRA guidelines and improving the productivity of QC labs by streamlining processes and removing bottlenecks in the system. He has been instrumental in the implementation of GMP/ Quality systems in compliance with guidelines/regulations like Schedule M, ICH Q7, USFDA, MCA, TGA, ANVISA, MCC, WHO, 21 CFR Part 210 & 211 etc. Handling of change control, Product complaints, response to regulatory audits, batch recall, CAPA, investigation, deviation management from set parameters/ regulations, OOS and Risk management. He has audited more than 75 plants that handle Drug Formulation, API, Intermediate and Packaging Material manufacturing. He has also handled Third Party manufacturing sites and ensuring timely batch release while making sure the required regulations are met. He has also effectively handled more than 50 inspections by reputed customers and regulatory agencies like USFDA, TGA, MCC, WHO, ANVISA, IMB, Ministry of Health (Russia) successfully. His core skills include Training and Development based on cGMP guidelines and regulations, Audit and compliance, Mentoring and Quality management system design and their effective implementation. Unflinching in resolve and surprisingly simple and logical in approach. He has started his career with Lupin and worked with organisations like Matrix Laboratories, Mylan Pharmaceuticals, Aurobindo Pharma, Ranbaxy, Sun Pharma, Dabur Pharma, Dr. Reddy’s Laboratories and Jubilant Generics.
5.00 (38 ratings)

14 Courses

1865 students