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Pharma Production/Manufacturing: Online Interactive Learning Program by Sunil Singh

Description

In this program, you are going to learn the basics of Pharma Production Manufacturing. The 15 modules (28.5 hours duration with 12 Assessments & 5 Assignments) of this program contains in-depth learnings about Pharma Industry, Regulations & Acts of Pharma Industry, Organization & Personnel, Equipment & Processes, Production & Process Control if OSD (Oral Solid Dosage) / API (Active Pharmaceutical Ingredients), Good Documentation practices, Maintenance of Batch Manufacturing & Packaging Records, Clean Room behaviors, Change Control, Data Integrity & much more. This program is recommended for both working professionals & freshers who want to join Pharma Production. 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: 28 hours & 30 minutes

Includes: 15 Modules, 12 Assessments & 5 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: Premises and Equipment – API/ OSD8 Topics120YesYes
Module 5: Production and Process Control – API/ OSD11 Topics120YesYes
Module 6: Packaging and Labeling8 Topics120YesNo
Module 7: Pharmaceutical Water System and HVAC System- GMP requirement3 Topics120YesYes
Module 8: Current GMP and Regulatory Challenges4 Topics120YesNo
Module 9: Process Validation (PV) and Cleaning Validation (CV)5 Topics120YesYes
Module 10: Equipment Qualification5 Topics120YesNo
Module 11: Clean room behaviors – OSD/ API6 Topics120YesYes
Module 12: Preparation of Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR)4 Topics120YesNo
Module 13: Good Documentation Practices (GDP)4 Topics120YesNo
Module 14: Change Control Management6 Topics120YesNo
Module 15: Data Integrity (DI)7 Topics120YesNo
Total88 1710 minutes (28.5 hours)125

What Will I Learn?

  • Basics of Pharma Manufacturing
  • Clean rooms & Behaviour
  • About Pharma Industry & regulation
  • Data Integrity
  • Batch Packaging & Manufacturing Records
  • Easily crack the interviews for entry level
  • Knowledge for promotion to next level

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

3,000.00

Material Includes

  • 15 Live Interactive Sessions
  • 12 Assessments
  • 5 Assignments
  • Course certificate

Requirements

  • Access with Laptop or Mobile
  • Good internet connectivity

Target Audience

  • Any graduate
  • B Pharm M Pharm BSc MSc D Pharm
  • 12th Passout
  • Anyone working in Pharma Production