To be verified
Duration: 2 Days
Location: 7 Centre Court, Blyry Business and Commercial Park, Athlone.
Accreditation: Certificate of Attendance
Full Fee: €795 including course manual, lunch and refreshments.
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.
- Understand regulatory requirements
- Understand key elements that should be in cleaning procedure
- Understand various cleaning methods
- Layout of cleaning protocol
Who is the course for
- Validation Engineers
- Quality Engineers
- Personnel designing cleaning methods
|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
Safety Shoes – Not Required on this course
This programme is a QQI component (minor) award, certified at Level 5 on the national framework of qualifications – see www.nfq.ie and is a mandatory component of major award 5M3080 – Plastics Injection Moulding.