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Formazione >> Webinar e Formazione Online >> Lifecycle management approach to Cleaning Validation

Lifecycle management approach to Cleaning Validation

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FREE ONLINE WEBINAR: To continue supporting our customers' needs this webinar is dedicated to manufacturers only. To allow all interested companies attend, maximum two delegates form the same company will be admitted. Due to the type of event and limited audience capacity, participation of companies not included in this category will not be accepted. Attendance will be confirmed from the event's organizers.

DATE: March 8, 2023 | 3.00 PM - 4.00 PM CET

OFFICIAL LANGUAGE: English

ATTENDEES CAPACITY: 250 delegates

The event will be hosted within Go ToWebinar platform. Your registration request for this webinar will be submitted to the organizer for approval. You will receive information via email regarding your registration status.

Introduction and overview

Cross-contamination must be avoided in the pharmaceutical industry and a successful cleaning ensures that patients are not put at risk due to cross contamination. Cleaning is a process and therefore it should be validated.

Cleaning validation is a highly regulated and complex process and includes a multistep assessment to cover a variety of aspects, form initial design up to field execution and monitoring. The process passes through risk-based assessments, according to Quality Risk Management principles and involves a multi-disciplinary team.

CV takes part of risk mitigation actions since it plays an important role in reducing the possibility of product cross-contamination and product carry-over in multi-purpose manufacturing equipment.

Other than EU-GMP Annex 15, the latest version of Annex 1 also emphasizes the importance of a cleaning program. The FDA guideline on Process Validation lifecycle approach is applied also to cleaning validation.

This webinar will sum-up the key steps of the lifecycle approach with the intention to help a compliant and successful cleaning validation process.

Agenda
  • Regulatory framework and introduction on cleaning and cleaning validation
  • Stage 1 – cleaning process design
  • Stage 2 – cleaning process qualification
  • Stage 3 – cleaning process verification
Speaker

Alessandra Prosperini is a Senior consultant for qualification and validation area at Eurofins Regulatory and Consultancy Services Italy.