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E-Learning Course: Advanced GMP for API/Bulk Operator (Certified)
CompuPharma Ltd
Having grasped the basics of GMP in 'Essential GMP for API/Bulk Operators', an operator now needs to move on to more advanced GMP concepts. Advanced GMP for API/Bulk Operators covers everything a trainee needs to know about more demanding CGMP topics such as SOPs, completing records, cleaning of equipment, QC status, use of computers, etc.
Standard Operating Procedures (SOPs) and records are critical in ensuring that operators are working in compliance with CGMP. This course explains why SOPs must be followed in API/Bulk facilities and what information they should contain. It also describes the proper completion of records in API manufacturing including batch production records (BPR), equipment records, records of materials and laboratory sample records. The importance of accurate labeling in an API/Bulk facility is also addressed, along with label distribution and reconciliation. Finally, the basics of Information Technology and Good Computer Practice are explained.
This course comprises the following modules:
- GMP - SOPs for APIs
- GMP - Records for APIs
- Labeling in API Plants
- IT Use in Regulated Industries
This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.
Also available
E-Learning Module: IT Use in Regulated Industries
E-Learning Module: GMP - SOPs for APIs
E-Learning Module: GMP - Records for APIs
E-Learning Module: Labeling in API Plants
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