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Advances in GMP for Pharmaceuticals
Rating: 4.4 out of 5(48 ratings)
275 students

Advances in GMP for Pharmaceuticals

Include Good practices in warehouse, analytical and, microbiology laboratory, data integrity and computerised system.
Created byHitendrakumar Shah
Last updated 9/2023
English
English [Auto],

What you'll learn

  • Pharmacy,pharmaceuticals professionals
  • This course has been updated to include the advances in Current Good Manufacturing Practices. This is two-days course
  • This is very important training. Failure to learn GMP principles can loose product and production licences.
  • Everyone who is working in pharmaceutical should be trained on this course

Course content

5 sections • 16 lectures • 17h 26m total length

  • Introduction4:35

    Master warehouse good practices per FDA guidance (21 CFR part 211, subpart E) for receipt, quarantine, storage, labeling, and sampling of raw and packaging materials, with aseptic techniques and documentation.

  • GMP in warehouse Part 11:15:36

    Examines good warehouse practices under GMP, highlighting regulatory expectations for receiving, storage, packaging materials, quarantine, stock rotation, and comprehensive documentation to prevent contamination.

  • GMP in warehouser part II1:06:03

    Explore good warehouse practices under GMP, covering sampling and testing, storage, quarantine, labeling, weighing, dispatch, and recall handling to ensure product quality and regulatory compliance.

Requirements

  • The person who is interested in learning should learn in focussed way to understand the concepts and practical approach.

Description

This course will help learners to understand advanced good manufacturing practices. This course is prepared with special attention on good warehouse practices, good laboratory practices, good computerized systems, and good data integrity practices. Further, this course will discuss good documentation practices and good review practices also. Further emphasis will be on Good behavior practices are also considered while developing this course. As Good behavior will first be required to ensure data integrity and good manufacturing practices. This course will further specifically have lectures on data integrity aspects of analytical laboratories and microbiology laboratories.

This course has many lectures. Below different points will be discussed in the lectures

Investigations, OOS, OOT in pharmaceuticals, stability study in pharmaceuticals, guideline expectations about different aspects of GMP, FDA citations, the computerized system compliance includes -  FDA part 11, business continuity plan, and excel spreadsheet validation also.

How you can be ready for inspection is also discussed with a special focus on computerized system requirements. Overall, this is the complete course for learning pharmaceuticals in all disciplines.

This course contains many recorded lectures. Kindly request you fully focus on each lecture to understand it in a better way.

Further, if you have any question/s, please put your questions in the comment section. I will respond to your questions.

Who this course is for:

  • Pharmacy students, consultants, This course is essential for software vendors, auditors, and quality staff involved in GxP applications. • Regulatory Affairs • QA/ QC • IT/IS • Software Managers • Project Managers • Software vendors and suppliers

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