Environmental Monitoring in the Pharmaceutical Sector

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

RABS – MORNING SESSION

Patrizia Muscas, Sterility Assurance Senior Consultant – Eli Lilly Italy

• Strengths of RABS technology
• Critical points to consider when choosing the technology:

– functionality, safety, compliance, maintenance, costs, versatility

• Criteria for choosing the number/position of glove accesses
• Classification and Monitoring:

– normative requirements
– choice of points
– technologies (alternative systems-potential)

• RABS gloves:
  – choice of points
  – typologies
  – certification
  – microbiological checks

– Integrity testing
– replacement frequencies

• RABS sanitization:
  – frequencies
  – choice of reagents

• Validation Highlights:
  – Smoke test
  – medium fill
  – operator validation
  – types of interventions grade A/B, material handling from class B within the RABS

• Cases of out-of-bounds deviation and approaches to their management

ISOLATOR – AFTERNOON SESSION

Andrea Pranti, Qualification Transformation Engineering Manager – GSK Vaccines – Siena

• Strengths of the Isolator technology and types:

– functionality, safety, compliance, maintenance, costs, versatility

• Material introduction and outfeed systems: IN and OUT ports
• Classification and Monitoring:

– normative requirements
– choice of points
– technologies (systems – alternative potential)

• Isolator Gloves:

– choice of points
– typologies
– certification
– microbiological checks
– integrity tests
– replacement frequencies

• Biodecontamination: modalities and problems
• Validation Highlights:

– smoke test
– medium fill
– operator validation

• Cases of out-of-bounds deviation and approaches to their management

Sterility Assurance Manager, QP, Quality Operations, Microbiology Manager, Maintenance and Engineering Manager, Production Manager.

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.