Environmental Monitoring in the Pharmaceutical Sector

PROGRAM

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

Day 1 – Speaker Leonardo Gabrieli

• Relevant national and EU regulations
• Role and Responsibilities of the QP, Annex 16
• Regulatory and compliance aspects
• Relationship between GMP and GDP
• Aspects pertaining to the Anti-Falsification Directive
• Good Documentation Practice & Data Integrity – Q&A-discussion
• API supplier/excipient qualification
• Technical agreements
• Complaints and Recall
• Final Q&A-discussion

Day 2 – Speaker Angela Petrigliano

• Batch Record Review /Release/ Batch Disposition.
• Deviations/MDD (Microbial data deviation)
• RCA / CAPA
• Change management
• Quality Risk management
• Essential and nonessential changes
• Process Validation
• Product Quality Review
• Management review
• Contamination Control Strategy -CCS
• Final Q&A-discussion

The course has been designed for the figure of the novice or experienced Qualified Person who needs an update on the latest regulatory news and trend regulators.

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.