Date: September 22, 2016
Time: 11am ET / 8am PT
This webinar will provide an overview of the FDA Guidance for the recent IDMP regulation and explain how pharmaceutical companies should prepare and build a solution to meet the IDMP specifications that are connected to the TrackWise system.
In advance of EMA's final IDMP guidance, Sparta Systems and Navitas have partnered to ensure organizations are prepared for implementation by offering an integrated solution: idmpREADYTM.
idmpREADY combines Navitas' data management technologies to capture, record, publish and maintain IDMP data points, together with Sparta's TrackWise QualityConnect framework to define, track, exchange and report IDMP core processes.
Areas covered in the Webinar:
- FDA and ISO requirements for IDMP
- Establishment of an IDMP strategy
- Develop a solution to meet the new IDMP regulations
- Integration between Sparta Systems' TrackWise and Navitas
- Regulatory and Compliance Management
- QA Management
- Quality System Auditors
- Consultants