Home

Hi All, Just following up on this? Is everyone using the online system or how are you tracking this? Thanks, Loga ------------------------------ Loganathan Kumarasamy, MS RAC Senior Consultant Waukegan IL United States ------------------------------

Since you don't have any prior history of stability of this product, the FDA's expectation is that you concurrently monitor the stability of the clinical batch (i.e. being dosed in FIH study) while the study is ongoing. Why not dose the technical batch and monitor the stability of this lot? BTW, the clinical batch should adhere to the phase 1 cGMP guidance. ...

Thanks, A lot for your very detailed answer  The Device is Portable Oxygen concentrator, of course, has a rechargeable battery, the External power supply is grounded ------------------------------ YASSER ESTAFANOUS Director of RA/QA Winter Haven FL United States ------------------------------

Dear Dan, That's correct. There was no request from the UK for an extension and the deadline for making such a request has now passed. IP completion day is set for 31 December 2020 and after that date, as far as the EU 27 is concerned, the UK will be just like any other non-EU country. My opinion: Those likely to be most affected will presumably ...

Hello Vicki, Here are some of our experience with using MS products as eQMS. We have been using SharePoint platform with Office365 integrated: Advantages: 1. Cost effective implementation 2. Quick In-house solutions / experts to modify workflows 3. Simple workflow process Challenges: 1. E-signature cannot be implemented easily with part 11 compliance ...