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Updated in [September 26th, 2023]

What does this course tell?
(Please note that the following overview content is from the original platform)
This course will help learners to understand 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 Good behaviour practices are also considered while developing this course. As, Good behaviour 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 is having many lectures. Below different points will be discussed in the lecturesInvestigations, 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.

We considered the value of this course from many aspects, and finally summarized it for you from two aspects: skills and knowledge, and the people who benefit from it:
(Please note that our content is optimized through artificial intelligence tools and carefully reviewed by our editorial staff.)
What skills and knowledge will you acquire during this course?During this course, learners will acquire the following skills and knowledge:
1. Understanding of good manufacturing practices (GMP) in the pharmaceutical industry.
2. Knowledge of good warehouse practices, including proper storage and handling of pharmaceutical products.
3. Understanding of good laboratory practices, including proper equipment maintenance and calibration, sample handling, and documentation.
4. Knowledge of good computerized systems practices, including compliance with FDA Part 11 regulations and validation of Excel spreadsheets.
5. Understanding of good data integrity practices, including the importance of accurate and reliable data in pharmaceutical manufacturing.
6. Knowledge of good documentation practices, including proper record-keeping and documentation of manufacturing processes.
7. Understanding of good review practices, including the importance of thorough review and verification of manufacturing records.
8. Awareness of good behavior practices, including the importance of ethical conduct and professionalism in ensuring data integrity and GMP compliance.
9. Knowledge of data integrity aspects in analytical and microbiology laboratories.
10. Understanding of investigations, out-of-specification (OOS), and out-of-trend (OOT) analysis in pharmaceutical manufacturing.
11. Knowledge of stability studies in pharmaceuticals and the guidelines and expectations related to them.
12. Familiarity with FDA citations and the importance of compliance with regulatory requirements.
13. Understanding of business continuity planning and its relevance to GMP compliance.
14. Knowledge of how to prepare for inspections, with a special focus on meeting the requirements for computerized systems.

Who will benefit from this course?
This course on Good Manufacturing Practices for Pharmaceuticals will benefit individuals working in the pharmaceutical industry, particularly those involved in manufacturing, quality control, quality assurance, and regulatory affairs. It will also be beneficial for professionals working in analytical laboratories and microbiology laboratories.

Specific professions that will benefit from this course include:

1. Manufacturing professionals: This course will provide manufacturing professionals with a comprehensive understanding of good manufacturing practices, including good warehouse practices and good behavior practices. It will also cover topics such as investigations, OOS (Out of Specification), and OOT (Out of Trend) in pharmaceuticals, stability study, and guideline expectations about different aspects of GMP. This knowledge will help them ensure compliance with regulatory requirements and improve the overall quality of pharmaceutical manufacturing.

2. Quality control and quality assurance professionals: The course will focus on good laboratory practices, including data integrity aspects of analytical laboratories and microbiology laboratories. It will also cover topics such as FDA citations and computerized system compliance, including FDA part 11 and excel spreadsheet validation. This knowledge will enable quality control and quality assurance professionals to effectively monitor and maintain the quality of pharmaceutical products.

3. Regulatory affairs professionals: This course will provide regulatory affairs professionals with a deep understanding of good manufacturing practices and documentation practices. It will also cover topics such as business continuity plan and how to be ready for inspection, with a special focus on computerized system requirements. This knowledge will help them ensure compliance with regulatory guidelines and facilitate the approval and registration of pharmaceutical products.

Course Syllabus

Good Warehouse Practices

Good Laboratory Practices

Data Integrity in Pharmaceuticals

Good Documentation Practices

Good Computerised System/IT practices