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.DUBLIN Dublin, city, Republic of Ireland Dublin, Irish Baile Átha Cliath, county borough (1991 pop. 915,516), Leinster, capital of the Republic of Ireland, on Dublin Bay at the mouth of the Liffey River. , Ireland Ireland, Irish Eire (âr`ə) [to it are related the poetic Erin and perhaps the Latin Hibernia], island, 32,598 sq mi (84,429 sq km), second largest of the British Isles. -- Research and Markets (http://www.researchandmarkets.com/reports/c35447) has announced the addition of E-Learning Course: Advanced GMP GMP (guanosine monophosphate): see guanine. for API/Bulk Operator (Certified See certification. ) to their offering. 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 standard operating procedure Medtalk A technique, method or therapy performed 'by the book,' using a standard protocol meeting internally or externally defined criteria; a formal, written procedure that describes how specific lab operations are to be performed. (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 (Application Programming Interface) A language and message format used by an application program to communicate with the operating system or some other control program such as a database management system (DBMS) or communications protocol. manufacturing including batch production Batch production is a manufacturing process used to produce or process any product in batches, as opposed to a continuous production process, or a one-off production. The primary characeristic of batch production is that all components are completed at a workstation before they records (BPR (Business Process Reengineering) See reengineering. BPR - Business Process Re-engineering ), 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. Topics Covered: --GMP - SOPs for APIs --GMP - Records for APIs --Labeling in API Facilities --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. GMP - SOPs for APIs What an SOP is, why SOPs must be followed in API plants and what information they should contain. GMP - Records for APIs How to complete records required for API manufacture. Records include batch production records (BPR), Master production records, equipment records, records of materials and laboratory sample records. Labeling in API Plants The importance of accurate labeling in an API Plant. What must be contained on a label, along with label distribution and reconciliation. IT Use in Regulated Industries Explains the basics of Information Technology and Good Computer Practice and looks at how IT is used in regulated industries. For more information visit http://www.researchandmarkets.com/reports/c35447 |
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