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.