הנושאים שמעניינים אותי
(אפשר לבחור מספר נושאים)
Computerized Systems: Annex 11 Revision, Data Integrity and the Quality SystemInteractive Workshop
מערכות ממוחשבות: עדכוני Annex 11
אמינות נתונים ומערכת האיכות
שימו לב - כיתת הלימוד התמלאה
ההרשמה והשתתפות בקורס היא דרך זום בלבד
Annex 11 Computerized Systems is being updated. A 32 point, five page concept paper has been issued for comment. Of 32 points raised, NONE is addressed in the existing 5 page annex. Based on...המשך קריאה
יש לך שאלה? יש לנו את כל התשובות
מה תכני הקורס?
- PIC/s Concept Paper on revision of Annex 11 What awaits industry in future inspections?
- Inspection / Audit findings and Warning letters We all have this problem…
- Brief review of Regulatory Guidance:
- WHO Data Integrity Guideline
- FDA Guidance: Data Integrity Q&A 2018
- MHRA Data Integrity Guidance
- PIC/s: Data Integrity in Regulated GMP/GDP Environments
- EMA Q&A on Data Integrity
- WHO Good Data and Record Management Practices
- Interactive Group Activity: develop checklist for oversight of computerised system service providers
- Quality Unit role vs rest of management
- Effective Internal Audits for Data Governance
למי זה מתאים?
This course is suitable for:
Executive management in virtual companies obtaining data from outsourced operations. Anyone working in the pharmaceutical industry including Company General Managers, Managing Directors, VPs, QPs, Quality Assurance, Quality Control and other quality professionals, Operations Managers, production managers, Research and Development, persons working in technology transfer, personnel working in pharmaceutical Active substance and finished product manufacture as well as distributors, brokers, wholesale dealers and anyone involved in the manufacture of starting materials, Active Substances, finished pharmaceuticals or involved in the handling, processing or sale or administration of any of these. Persons involved in clinical trials and manufacture and administration of Investigational Medicinal Products will also find the course very useful as will regulatory personnel.
מה אקבל מכך בפועל?
Participants will come away from this course understanding:
- What is a GMP-impact computerised system
- Data integrity issues from recent 483 and warning letters what is a real problem and what is background noise?
- How data integrity lapses happen
- How to work with and effectively oversee computerised systems service providers: what does YOUR company need to do?
- How to integrate automated / digital and digitized solutions to reduce dependence on humans and eliminate human error
מי מעביר את הקורס?
