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E-Learning Course: Advanced GMP for Finished Dose Operators (Certified)
CompuPharma Ltd
Having grasped the basics of GMP in 'Essential GMP for Finished Dose Operators', an operator now needs to move on to more advanced GMP concepts. “Advanced GMP for Finished Dose 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 begins by explaining why SOPs must be followed in finished dose facilities and what information they should contain. It also describes the proper completion of records in finished dose manufacturing including production records, equipment records, records of materials and laboratory sample records.
Proper labeling and cleaning of equipment are vital in avoiding mix-ups and product contamination. This course takes an in-depth look at both of these areas – the importance of accurate labeling is stressed, along with label distribution and reconciliation, while different equipment cleaning methods used in the pharmaceutical industry are also explored.
The course continues with CGMP in the warehouse and Quality Control (QC) status of materials and products. The CGMP design requirements for manufacturing facilities are also examined with emphasis on product flow, environmental controls, cleaning and sanitization. Finally, the basics of Information Technology and Good Computer Practice are presented.
The course consists of the following modules:
- GMP - SOPs for Finished Dose
- GMP - Records for Finished Dose
- Personnel and Training
- Warehousing
- Cleaning of Equipment
- Sampling
- Buildings & Facilities
- IT Use in Regulated Industries
This is a self paced highly visual interactive e-Learning course, 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.
Lessons can also be purchased individually. Please see the “Also available” links below for further information on each of the individual lessons.
Also available
E-Learning Module: IT Use in Regulated Industries
E-Learning Module: GMP - SOPs for Finished Dose
E-Learning Module: GMP - Records for Finished Dose
E-Learning Module: Personnel and Training
E-Learning Module: Warehousing
E-Learning Module: Cleaning of Equipment
E-Learning Module: Sampling
E-Learning Module: Buildings & Facilities
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