Read our free Case Study: Remediation Project - Massachusetts
During the calendar year of 2015 and continuing to the present day, The FDA Group assisted in the planning and execution of a comprehensive remediation project in response to Warning Letters issued to a large healthcare Company citing a range of deficiencies.
Read our free case study and learn:
- Which kinds of compliance problems were cited in the Warning Letters
- How The FDA Group worked closely with the Company's quality and compliance personnel to assess the current quality plan, conduct thorough record reviews, and write new protocol
- How The FDA Group identified eight significant deficiencies in all subparts of CAPA and improved internal processes to successfuly resolve those issues