Training & seminars
Advanced Process Validation and Cleaning Validation
9 May 2016
Where
The Boulevard St Giles Premier Hotel<br />Mid Valley City<br />Lingkaran Syed Putra,<br />59200 Kuala Lumpur, Malaysia
Aim: To develop advanced understanding of Sterile and Non Sterile Process and Cleaning Validation in order to comply with contemporary regulatory expectations. Putting into perspective the interpretation of regulatory and industry guidance.
Day 1
AM ► PIC/s Annex 1 and FDA Guidance on Process Validation
AM ► Room classification and ongoing re-validation
PM ► Media fill trial data interpretation
PM ► Ongoing re-validation
PM ► Management Review
Day 2
AM ► Solid-dose validation (tablets, capsules and powder)
AM ► Aseptic liquid and powders filling validation (vials and syringes)
PM ► Validating the freeze drying process
PM ► Process capability analysis for process validation
Day 3
AM ► Worst-case scenarios for cleaning validation studies
AM ► The process equipment train
PM ► Recovery studies, swabbing and rinse studies
PM ► Selectivity, LOD and LOQ
Download the brochure and registration form.