Quality Risk Management in Pharmaceuticals ICHQ9(R1)
What you'll learn
- Performing quality risk management
- Practical implementation of QRM
- Updates in quality risk management
- This course is self made for personal upgradation in pharmaceuticals
- The person should be full focussed during the session.
The training lecture will help you to learn a brief introduction of the topic and scope Brief on ICH Quality Guidelines and Understanding guidelines for Quality Risk Management Updates in the new version of the guideline ICH Q9 (R1) Understanding of – Managing your risk has its own rewards. Role of ICH Q9 with ICH Q8 and ICH Q10 Practical understanding of Quality Risk Management (QRM) process and how to perform QRM by failure mode effect analysis tool. Action Priority Tablet concept/Heat map matrix Vote of Thanks - Q&A session.
Further, there is a small video lecture that will help you to understand Quality Risk Management principles, how it is simple and easy to implement and achieve the compliance level. We have explained this with simple examples.
The last lecture video will help you to learn further about Good Review practices. This training will include, some examples of Food and Drugs Administration (FDA) citations, regulatory expectations about the review, 10 key principles about good review practices, how to qualify reviewers, and many more.
Overall this training session will take you through an understanding of quality risk management, what is updated in the revised ICH Q9(R1) guideline, with practical examples and good review practices based on risk-based approach.
Who this course is for:
- Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), production, engineering, R&D, development, investigation team, compliance team etc.
A Quality-oriented professional with over 23 years of experience in Quality Assurance, Quality Control, Quality Engineering, Quality auditor, pharmaceutical regulations, and regulatory audit compliance.
The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.
The key competencies include Quality Compliance, Supplier Audit, building systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation, and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post-approval queries raised by regulatory agencies, etc.
·Independently handled - Quality assurance and Quality Control department for more than 13 years.
· Audits faced- USFDA (7 times), ANVISA, MHRA, MCC, TGA, IDMA excellence, WHO audit, EU regulatory (8 times), Yemen MOH, Digemid (Peru), Russian Authority audit, etc.
· Analytical Background: The analytical background includes, physical, chemical, and microbiological testing of raw material, finished product, and stability samples. Handled the chromatographic instruments – HPLC, GC, IR, UV-visible spectrophotometer, AAS, etc.
· Technical support-
o cGMP and data integrity gap audit.
o Support in facing regulatory audits & compliance report review
o Support in product development and/or regulatory submission or evaluation of readymade dossiers which can be used after site transfer for commercial manufacturing.
· Expertise in GXP Computerised systems-
o Major Software handled - Lab solution software, Empower 3 software, LIMS, TRIMS & Track wise
o Provide technical support to process owner during Computer system validation, Review of Computerised system validation documents for compliance, auditing the computer system supplier, performing GAP audit of Computerised systems, Evaluation of Computerised systems with respect to cGXP compliance, data integrity controls and ease of operating pragmatic approach
· During tenure audited more than 500 vendors/suppliers and trained more than 5000 candidates. I am an approved Auditor by the multinationals I worked and also I am a CQI-IRCA Certified QMS/Lead Auditor as per ISO9001:2015).