Guidance and counseling related to FDA audits are among the services that Innokas Medical has provided for its customers. Now Innokas Medical has created a separate product based on this know-how, which it now offers also to companies that otherwise do not use Innokas Medical’s services.
FDA Coaching is a two-day package. On the first day the company’s quality system and facilities are audited. Practical arrangements that the company needs to carry out to ensure a successful, efficient audit are also gone over.
The second day consists of a practice audit. Then the audit procedure, the types of facilities that need to be available, who needs to be present, and what their role is are gone over.
“The second day of coaching differs according to the company’s own situation; it focuses on issues that require the company’s particular attention. Innokas Medical’s service is practical—we do not simply provide theoretical lists related to the topic. Our customers have said that Innokas Medical’s FDA Coaching is beneficial and really helps”, says Tiina Kotipalo, Director in Quality and Regulatory Affairs at Innokas.
“We also provide assistance in actions taken after the audit—how the company should document the audit for itself and how it should react to nonconformities”, Veteläinen continues.
This service is meant especially for companies that know or expect that an FDA audit is forthcoming.
Director of Quality and Regulatory Affairs, Tiina Kotipalo, firstname.lastname@example.org, +358 44 562 3131