FDA expects that all data be reliable and accurate (see the “Background” section). CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models.
- Applying in parallel with an EU marketing authorisation application
- Notified bodies’ audits performed in the context of quality management system assessment
- FORMAÇÕES 2021 : CREDITAÇÕES PELA ORDEM DOS FARMACÊUTICOS.
- Calendário de formações 2021
- IMPLEMENTATION ROLLING PLAN Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Update dec 2020
- Register medical devices to place on the market
- 14ª Edição da formação sobre as BPD: “Uma revisão abrangente da temática ,que combina a legislação com casos práticos”
- Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025