GMP Implementation and Auditing Training

RFQ/OBP370/2025/26

Training contents requirements: Key Learning Objectives On completion of this course, trainees must be able to: Explain the origin and reasons for GMP Apply the practical interpretation of GMP expectations and best practices Identify EudraLex and PIC/S expectations To perform better audits Become a Certified GMP Pharmaceutical Quality Systems Lead Auditor. Understanding, skills and confidence to audit all aspects of pharmaceutical manufacture and control. Course Outline Overview of EU law and requirements relating to medicines EudraLex Volume 4 Quality Risk Management - ICH Q9 Pharmaceutical quality systems and ICH Q10 Management responsibilities Documentation and records Validation - the basics Supplier assurance Facility design and GMP requirements for different dose forms/routes of administration Good Control Laboratory Practice Self-inspections Change management Investigations - deviations and CAPA Complaints, quality defects and recalls Training Principles and Audit Planning -Planning and preparation -Audit types and techniques -Establishing an audit program for suppliers, contractors and company sites -Internal vs. external audits -The audit process Auditor Skills and Competencies -what makes a good auditor -Communication skills, questioning and listening -Body language and non-verbal communication -Overcoming apathy, resistance and aggression -Effective note taking -Auditor continuing professional development -Assessing the auditor -Managing auditors Initiating, Preparing and Conducting the Audit -Materials management -Documentation systems -Pharmaceutical quality systems -Sterile products -Oral solid dose -Packaging and many more Concluding the Audit -Wrap-up -Follow-up The course must also be designed for auditors assessing: Manufacturing operations Contract manufacturing organizations API suppliers Excipient suppliers Packing component suppliers Service providers Training method: Face to face/In class Assessment: Required Training Material: Include study material /copy of presentation Competency certificate: Required Facilitator Requirement: background in 5 years' experience in training GMP implementation and auditing. SETA certified as a facilitator, Training provider: Services SETA registered/accredited

Request for Quote

2026/02/18 15:00:00

No

RFQ/OBP370/2025/26