21 CFR Part 11 and FDA Compliance
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology
Drug and Device October 2024
Reminder: We are now in the registration renewal period for both drug establishments and medical device facilities. Drug listing certifications must also be submitted between 1 October and 31 December annually. If you need assistance with the process, please contact...
Good ANDA Submission Practices
Good ANDA Submission Practices Proactive Planning for the Best Possible Outcomes Presented by Radhika Rajagopalan, Ph.D., EAS Independent Consultant FDA recent draft and final guidance documents related to generic drugs indicate the Agency’s thinking with regards to...
Drug and Device September 2024
The FDA Drug and Medical Device Registration renewal period begins 1 October 2024. With the drug listing certification period upon us, it is a good time to confirm your NDC listings are all accurate. Any NDC SPL file requiring updates should be done prior to 31...