The first 30 seconds is a danish introduction, you can skip it and go directly to the talk which is in english.

Are there any differences in terms of compliance issues cross-country (or even regions)? Yes and no. In general, there are only minor differences in GMP. However, speaking of auditing, differences almost always exist.

FDA's revised compliance programs on pre-approval inspections (PAI) includes three overall objectives.

1. Are your company ready for this marketed product
2. Data integrity. Are data submitted to the FDA reliable?
3. Whether or not a company is fulfilling its commitment that was made in the submission to the FDA

A mock-up audit (audit before the real audit) should be focusing on the conformance to these three objectives. Non-conformances almost always exist documenting that companies are not well-prepared for the PAI

Statistics on validation issues in terms of warning letters (warning letter citations). Top issues within validation as seen in warning letters 2017:

1. Process validation
2. Cleaning validation
3. Sterilization validation
4. Analytical methods validation

FDA has finalized the guideline for Validation of Analytical Methods published (Analytical Procedures and Methods Validation for Drugs and Biologics, July 2015. See www.fda.gov).

Here you will find requirements to make use of a life cycle approach as also make use of statistical evaluations when evaluating your methods validations results.