How Question Based Development can Demonstrate Quality by Design and how it can Facilitate Continued Process Verification??
Recent organizational changes at CDER/FDA have created a new ‘supper’ Office of Pharmaceutical Quality to improve information and knowledge sharing and decision- making; (a) within New and Generic CMC Review function, and (b) between CMC Review and CGMP Compliance functions. ‘Question based Review’ and ‘Continued Process Verification’ are two themes can be expected to have a significant impact over the next several years on how product development, validation and manufacturing is carried out in industry and how FDA will review and inspect these functions.
If the above issue is important for you and you would like to be enlightened on the same you ought to be in Chandiarh for “QbD in Pharma Development World Congress 2015” on April 16, 2015 in Chandigarh. Dr Ajaz Hussain, Former FDA Reviewer and Currently Executive Director, NIPTE, USA will be there to address this issue and many more.
Just SMS QbD at 7696125050 and we will get back to you with more details.