Tuesday April 17, 2018
12:00 Noon – 1:30 pm EDT
Instructor: Marsha Steed (Hardiman)
Qualification of a cleanroom is a critically important task for any healthcare company manufacturing in controlled environments. There is often a push from management to get the new cleanroom(s) or renovated cleanroom(s) into a state that is ready for production use as soon as possible. The proper balance of compliance and business risk often comes into play. The people responsible for planning the qualification of a cleanroom need to determine how much qualification is required to ensure that the cleanroom(s) are ready for use and will perform as expected. Often times, people confuse commissioning activities, cleanroom classification requirements, cleanroom qualification (EMPQ) activities and routine monitoring. This course will describe the differences between each of these separate activities and look at ways of applying risk to rationalize the appropriate number of runs, sample site locations, number of samples to collect, etc. How many runs is enough for EMPQ? How much data is needed prior to going into production? How do you ensure you have rationalized your plan using risk? In this course we will discuss:
- Cleanroom Qualification Regulations and Guidance
- Commissioning of Cleanrooms
- Cleanroom Classification
- Cleanroom Qualification (EMPQ)
- Baseline Monitoring
- Routine Monitoring
- Risk Analysis Tools for Cleanroom Qualification Activities
- Clarifying the Differences between these Activities
- Business versus Compliance Balance
- Documentation of Risk Rationales
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-016