Dates:
To be verified.
Duration: This course will run over 4 webinars ( 4 mornings) from 09:30 - 1.00pm
Location: 7 Centre Court, Blyry Business and Commercial Park, Athlone.
Accreditation: Certificate of Attendance
Full Fee: €450
Course code: CLVOL
Programme overview
This course is designed to provide detailed understanding of cleaning validation for regulated industries, with particular focus on medical device and pharmaceutical cleaning activities.
We can deliver a shorter tailored programme at our centre in Athlone for you/ or on-site if you have injection moulding capability there.
Who is the course for
- Validation Engineers
- Quality Engineers
- Personnel designing cleaning methods
Learning outcomes
- Understand regulatory requirements
- Understand key elements that should be in cleaning procedure – TACT
- Understand various cleaning methods
- Layout of cleaning validation protocol
- Understand about ADE (Acceptable Daily Exposure) and PDE (Permitted Daily Exposure) limits
- Understand dedicated cleaning equipment approach
Content
Module 1: | Validation Introduction |
Module 2: | Regulatory Background – FDA,HPRA approach |
Module 3: | Designing a cleaning Procedure |
Module 4: | Basic Chemistry of Cleaning |
Module 5: | Best Industry Approach to Cleaning Studies |
Module 6: | Cleaning Methods |
Module 7: | Calculation of carry over limits |
Module 8: | Development of Bracketing procedures |
Module 9: | Hold Times (DEHT),(CEHT) |
Module 10: | Identification of Hard to Clean Places |
Module 11: | Documentation |
Module 12: | Cleaning of Dedicated equipment |
Trainer Profile
TP Lowry has over thirty years in medical device and pharma industries working as Analyst, Engineer, Quality Manager to Operations Director. Consultant for the past sixteen years.
MBA , Doctor of Quality Management