Remote Audits

Structure of the course

09:30 – 12:30 COURSE SESSION

Program

Times are UTC +1 (Rome time)

9:30

Overview of guidance documents

• Definition and scope
• Actual and potential future applicability

Peculiarities of remote audit

• Communication
• Systems access
• Documents sharing
• Document review
• GMP operations overview

Remote audit vs. on-site audit

• Plant tour
• Communication and inter-personal relation
• Time management

10.45

Remote Audit Step 1: audit planning and feasibility

• Audit plan:
• Priorities
• Risk/criticality assessment
• Early contact with Auditee
• Feasibility questionnaire and “negotiation of practical items”

Remote Audit Step 2: audit agenda

• Audit announcement
• Resources requirements
• Inclusion of practical items and potential challenges in agenda
• Who’s in charge of practical items?

12.00

Remote Audit Step 3: conducting remote audit

• Opening meeting
• Audit execution
• Wrap-up meeting
• Closing meeting

Remote Audit Step 4: audit report

• GMP/GDP non-compliance: Findings rating and classification
• Audit report conclusions

12.30

Workshop – Final session
Discussion on case studies presented during previous sessions

Q&A

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.