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E-Learning Course: Advanced GMP for Solid Dose Operators (Certified)
CompuPharma Ltd
Having grasped the basics of GMP in 'Essential GMP for Solid Dose Operators', an operator now needs to move on to more advanced GMP concepts. Advanced GMP for Solid 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 solid dose facilities and what information they should contain. It also describes the proper completion of records in solid 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 explained.
Topics covered:
- GMP - SOPs for Finished Dose
- GMP - Records for Finished Dose
- Personnel and Training
- Warehousing
- Cleaning of Equipment
- Sampling
- Buildings and Facilities
- Process Routine
- IT Use in Regulated Industries
Certificate
There is a 16 question assessment associated with each lesson within the Course and we offer a Certificate Service in which Users who achieve 100% in the assessment associated with each Lesson of a Course are deemed to have passed the Course, and are posted a Certificate.
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