Good Manufacturing Practices (GMP) & GMP AUDITS

Explore Good Manufacturing Practices (GMP) and practice 250 audit questionare for full confidence !
What you'll learn
Understand and define main principles of Good Manufacturing Practices (GMP)
Explore and define audit approach in GMP systems
Explore and understand audit type/process in GMP systems
Understand audit approaches and investigate audit question types
Define general scope of quality management/quality assurance in pharmaceutical industry
Understand and define main principles of Good Laboratary Practices (GLP)
Understand and define main principles of Good Hygiene Practices (GHP)
Understand and define main principles of Good Documentation Practices (GDP)
Requirements
Require mobile/tablet/laptop/personal computer with internet
To be student, graduate and/or pharma professional
Description
Good Manufacturing Practices (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. GMP Audit refers to regular visits to evaluate facilities, production and ensure that all activities are in line with current good manufacturing practices (cGMP). Quality Management (QM) is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. COURSE AGENDA 1 Introduction to GMP & GMP AUDITS 2 General Information about GMP Audits 3 Quality System 3.1. Good Manufacturing Practices (GMPs) 3.2. Basic Requirements of Good Manufacturing Practices (GMPs) 3.3. Pharmaceutical Quality System 4 Personnel 4.1. Personnel 4.2. Personnel & Hygiene 5 Premises & Equipments 5.1. General Information about Premises & Equipments 5.2. Premises & Equipments Requirements in Manufacturing Area 5.3. Premises & Equipments Requirements in Storage Area 5.4. Premises & Equipments Requirements in Quality Control 5.5. Equipment 6 Documentation 6.1. General Information about Documentation 6.2. Specification 6.3. Manufacturing Documentation 7 Production 7.1. General Information about Production 7.2. Contamination, Cross Contamination, Mix-up 7.3. Cross-Contamination 8 Quality Control 8.1. General Information8.2. Good Laboratory Practices 9 Quality Assurance 9.1. Product Quality Review (PQR) 9.2. Complaints 9.3. Change Management 9.4. Deviation 9.5. Corrective Action & Preventive Action 10 Additional Audit Questionare 11 Conclusion
Who this course is for
Learners who desire to take a part in Quality, Production and Research&Development Departments in Pharmaceutical Industry
Anyone who is looking to learn quality and audit approaches in pharmaceutical industry
Anyone who interest GMP certification in pharmaceutical industry
Existing pharma professionals who are looking to progress in their jobs
Anyone who is looking to get entry in pharmaceutical industry
Homepage

https://www.udemy.com/course/good-manufacturing-practices-gmp-gmp-audits/