Inspection Readiness Documentale

PROGRAM

09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION

• Structure of a Process Document.
• Major observations encountered and reported during inspections (483 and AIFA observations)
• Introduction to document review management- gap-analysis
• Verification of the type of error and coding of the same
• Practical examples of error types and how to achieve effective and efficient documentation
• Organization of the “war room” to effectively manage the document request at the inspection stage
• Question and answer session
• Performance indicators and improvement
• Error coding and error tabulation
• Realization of process KPIs and calculation of review times
• Verification of the process document Vs what was performed in the field
• Supervision, correction and approval of documentation
• Implementation of continuous documentation improvement methodologies
• Practical examples of reviewing a process document
• Question and answer session

QA Manager, CQ Manager, Production Manager, Microbiology Manager, Validation Manager, Audit Manager, Documentation Specialist.

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 info@pharmaeducationcenter.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 info@pharmaeducationcenter.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.