Preparing for an inspection from an Healthcare Authority
Preparing for an inspection from an Healthcare Authority
Our French colleague Karine has 17 years experience in conducting autits and preparing for inspections in an international environment in the life sciences sector.
Karine has prepared and attended audits by the FDA, the EMA, the MHRA and much more.
As you know, all organisations in our sector need to comply with GxP if they source, manufacture, distribute or develop healthcare products or any products that fall under the scrutiny of a healthcare authority:
Such products can be, depending on the country
- drugs
- medical devices
- diagnostic in vitro
- cosmetics and perfumes
- food supplements
- etc.
GxP are comprised of the following:
- Good Laboratory Practices (GLP)
- Good Manufacturing Processes (GMP) and GAMP
- Good Clinical Practices (GCP)
- guidelines for electronic signatures and electronic records (e.g. CFR 21 Part 11 or its European equivalent)
- and much more.
Karine can train your teams on the regulations, draft SOPs and deliverables, and perform test audits so your organisation gets ready for inspections.
Such work can be done on site or remotely if relevant.
For more information, contact Karine at k.i.renault (at) pharmarketing.net : she will help your organisation prepare for an inspection!