Training Process Auditor (Lean GMP/13485:2016)

Training Structured Process Auditing

Professional process auditor training.

We learned process auditing already in the year 1993. We have trained and certified many professional auditors.

This process auditing method has been expanded by us with the EU and US Pharma cGMP.

ISO 13485:2016 used as the QMS backbone has been extended with cGMP (all for you  relevant) requirements.

Durig this 2 day training you learn all that is needed to become a professional QMSR process auditor for combination products.

The 2 training days will end with a theory exam. When you complete 2 internal process audits following the training (that will be reviewed by us). If all training requirements are met, you are entitled to be certified.

Subjects that for part of our training (e.g.):

• QMSR audit schedule
• Preparing for the audit
• Audit of the Documented QMS
• Traffic light method
• Creating the audit plan
• Templates for processing and recording the audit
• Thoroughness of the audit  (including duration)
• Closing meeting and follow up
• Extending this method to other cGMP area’s (e.g. GDP)
• Training group of 5 – 10 members is ideal
• We expect that before participating, candidates have read (and understood) ISO 13485:2016.

Interested?

(Training material: English.  Language: English, Deutsch)