GMP Training Course | Full Free online course videos | Pharmaceutical Industry | Pharmacy скачать в хорошем качестве

GMP Training Course | Full Free online course videos | Pharmaceutical Industry | Pharmacy

GMP Training Course | Full Free online course videos | Pharmaceutical Industry Related videos to boost your knowledge:    • What is Alcoa? Data Integrity in pharmaceu...      • Deviations in Pharmaceutical Industry 💊 De...      • CAPA in Pharmaceutical Industry [2026 Guide]      • Project Management in pharmaceutical indus...      • 10 Golden rules of GMP [2026] | Free GMP T...      • How to qualify HPLC: Qualification Explain...      • Change Control in pharmaceutical Industry ...      • Batch Record Review [FULL GMP Training in ...   Topics covered: GMP (Good Manufacturing Practice) What is GMP? Good Manufacturing Practice (GMP) is a system of regulations and guidelines that ensures products like pharmaceuticals, medical devices, and food are consistently produced and controlled according to quality standards. Its goal is to minimize risks inherent in any production that cannot be eliminated through testing the final product. What are the key principles of GMP? The five main components of GMP, often called the "5 P's," are: People, Premises, Processes, Products, and Procedures (or Paperwork). These principles cover everything from having qualified and trained personnel to maintaining clean facilities, documenting all procedures, and ensuring product quality. What is the difference between GMP and cGMP? cGMP stands for "current Good Manufacturing Practice." It emphasizes that companies must use up-to-date technologies and systems to comply with the regulations. Compliance isn't a one-time event; it requires continuous improvement and staying current with industry standards. Project Management in a Lab Environment Why is project management important in a lab? Project management provides a structured approach to laboratory activities. It helps with planning new experiments, validating equipment, implementing new software (like a LIS), or developing new products. It ensures that projects are completed on time, within budget, and meet all quality requirements. How does a project manager's role differ in a lab? A lab project manager needs to have a strong understanding of both project management methodologies and scientific principles. They must be able to manage resources (people, equipment, materials), create detailed project plans, and communicate effectively with scientists, technicians, and management. What are some common project management methodologies used in labs? Labs often use a hybrid approach, combining traditional "waterfall" methods for structured, sequential tasks (e.g., method validation) with more agile methods for R&D projects where flexibility is key. Quality Assurance & Lab Operations What is the difference between Quality Assurance (QA) and Quality Control (QC)? Quality Assurance (QA) is a proactive, process-oriented system. It focuses on preventing defects by establishing a quality management system (QMS) with a strong emphasis on documentation, training, and auditing. Quality Control (QC) is a reactive, product-oriented system. It involves the testing of products and materials to detect defects. QC ensures that a final product meets its specifications before it is released. What is the role of a Quality Assurance person in a lab? A QA professional is responsible for implementing and maintaining the lab's quality management system. They write and review standard operating procedures (SOPs), conduct internal and external audits, manage corrective and preventive actions (CAPA), and ensure all lab activities comply with regulatory standards like GMP or GLP (Good Laboratory Practice). What is the importance of documentation in a regulated lab? In a GMP or GLP-regulated lab, documentation is critical. It provides a complete record of every activity, from raw material receipt to final product testing. Accurate documentation ensures traceability, demonstrates compliance during audits, and helps in troubleshooting if something goes wrong. What are some key lab safety and compliance practices? Key practices include following a Chemical Hygiene Plan, proper use of personal protective equipment (PPE), correct handling and disposal of chemical and biological waste, regular calibration and maintenance of equipment, and comprehensive training for all personnel.