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
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
- 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
|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 12:||Cleaning of Dedicated equipment|
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