Inspections and Audits at the Microbiology QC Laboratory

09:00 – 13:00 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION

• Regulatory context and guidelines with particular reference to the requirements of the new Annex 1
• How an AIFA/FDA Inspector prepares for a regulatory inspection
• How to prepare and manage the regulatory inspection
• Microbiological Best Laboratory Practices
• Infrastructure of a microbiological analysis laboratory
• Management of reagents, media and standards
• Microbiological cultures
• Equipment and tools
• Laboratory controls, handling and sample flow
• Methods of analysis and validation
• Records and documentation
• OOS and MDD (microbial data deviation)
• Data integrity in the microbiology laboratory
• Staff training
• Recurring deviations in AIFA and FDA regulatory inspections

Analysts and microbiology laboratory workers, Scientists, Supervisors and Managers of microbiology laboratory, QC and QA, Auditors and inspectors.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email in**@ph*******************.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting in**@ph*******************.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.