Eileen Flynn (owner) has 30 years of compliance. I have worked in large biopharma companies, small companies and for the US government (NIH) so I understand the need to customize compliance for the size and stage of your corporate development. I have experience performing:
- Complex risk assessments (API/DP FMEAs, clinical trial site audit assessments, Covid-19 remote monitoring risk assessments.
- GCP/GLP and GMP audits as well as clinical trial site audits
- Deviation/OOS investigations
- Batch record review and release
- Analytical and validation protocol review
- PAI preparedness for GCP and GMP
- SOP and report writing