Environmental Monitoring in the Pharmaceutical Sector
- 1° EDITION: 11 December2024
- 2° EDITION: 24 March 2025
- Online
- Italian
- 1° EDITION: 11 December2024
- 2° EDITION: 24 March 2025
- Online
-
- Italiano
Training overview
In the pharmaceutical industry, especially in sterile production, environmental monitoring (EM) of classified areas and utilities plays a fundamental role in ensuring that production occurs in compliance with required standards.
The results of environmental monitoring are included in the final assessment of the batch for release onto the market. Validation and periodic revalidation of environments, along with routine environmental monitoring programs, ensure that classified areas provide an appropriate environment in accordance with regulatory and design requirements.
Environmental monitoring assumes an effective system for detecting excursions from established limits, promptly triggering the investigation and risk assessment process for product quality.
The timely and careful processing and evaluation of environmental monitoring data (Trend Analysis) represent an important tool for identifying negative excursions and alerting to the risk of potential system contamination, prompting us to review and assess the typical flora of environments, any emerging microorganisms, and overall air conditioning and treatment systems, cleaning and sanitization operating procedures, personnel and material flows, and operator behavior and performance.
Key points of the training
- The regulatory requirements related to Environmental Monitoring
- The sampling methods and techniques, and how to validate them
- Perform microbiological and particulate validation of environments
- A redigere un Risk Assesment (scelta dei punti/programma di monitoraggio).
- A gestire la Trend Analysis (elaborazione dei dati, valutazione, documentazione)
- A determinare i limiti di allerta e gestire i trend avversi / isolati ambientali
- A garantire la Data Integrity dei dati del monitoraggio ambientale
- Le osservazioni ricorrenti da parte delle autorità regolatorie
- A gestire i fuori specifica del monitoraggio ambientale
Struttura del corso
09:30 – 12:30 SESSIONE MATTINA
14:00 – 17:00 SESSIONE POMERIGGIO
Programma
SESSIONE A – RIFERIMENTI NORMATIVI
- Annex 1
- Linee guida ISPE
- ISO 14644
- PDA tecnical report n°13
- USP 1116
- Linee guida FDA
SESSIONE B – CAMPIONAMENTO
- Microbiologico: aria, superfici, personale, utilities
- Particellare: aria
- Gestione terreni coltura, materiali ed attrezzature di campionamento
- Come convalidare il metodo di campionamento
- Come convalidare gli holding time di analisi ed incubazione
- La formazione e qualifica del personale coinvolto nel monitoraggio ambientale
- Attività di sampling e manipolazione di campioni
- Lettura ed interpretazione dei risultati
- Data integrity dei dati del monitoraggio ambientale
SESSIONE C – TREND ANALYSIS E DETERMINAZIONE DEI LIMITI DI ALLERTA
- Elaborazione statistica e valutazione quantitativa e qualitativa dei dati del monitoraggio ambientale
- Come strutturare e gestire un documento di Trend Analysis
- Come calcolare i limiti di allerta
- Calcolo del CCR (Contamination Recovery Rate)
- Isolati ambientali e loro gestione
SESSIONE C – FUORI LIMITE DI ALLERTA ED AZIONE, TREND AVVERSI, PRESENZA DI MICRORGANISMI INDESIDERATI
- Azioni da intraprendere in caso di superamento dei limiti, di trend avversi e presenza di microrganismi indesiderati
- Come strutturare e gestire l’indagine
- Il ruolo dell’identificazione microbica
SESSIONE D – CONVALIDA DEGLI AMBIENTI
- Requisiti normativi per la convalida e riconvalida degli ambienti
- La convalida dei sanitizzanti e la convalida degli ambienti
SESSIONE E – COME STABILIRE UN PIANO DI MONITORAGGIO AMBIENTALE
- Requisiti normativi per la scelta dei punti, tipologia e frequenza di campionamento
- Come strutturare un RA relativo al piano di monitoraggio ambientale
- Quando revisionare il piano di monitoraggio
- Il monitoraggio ambientale nelle sessioni analitiche
SESSIONE F – ATTESE REGOLATORIE
-
- Documentazione da preparare ed attenzionare
- Principali aspetti del monitoraggio ambientale trattati in sede di Ispezione
- Esempi di non conformità riscontrate in fase di ispezione
Analysts/Supervisors/Managers CQ Micro, Officers/Specialists/Managers AQ and Compliance, Qualified Persons, Validation Staff and Managers, Officers/Specialists/Managers SA
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.
Speakers
Damiano Comunale
Pharmaceutical Consultant
Damiano has 15 years of experience in the pharmaceutical microbiology sector, particularly in Environmental Monitoring, Quality Control, Quality Assurance, and Sterility Assurance. He has worked with various pharmaceutical giants like Eli Lilly, Merck Serono, Thermo Fisher, and Teva, he held roles ranging from QC Manager to Microlab & Sterility Assurance Senior Manager.
Over the years, Damiano gained a deep understanding of method validation, microbiological testing, environmental monitoring, aseptic processes and techniques, comprehensive management of QC laboratories, personnel qualification/training activities, and relevant regulations. He was involvedt in preparing and conducting numerous regulatory inspections (both pre-approval and routine) by agencies such as AIFA, MINSAL, FDA, and ANVISA is notable. Currently, he is engaged in providing training and consultancy services in the Pharma sector.
Interested in Quality & Process training?
Enroll in 3 courses and you’ll get a 15% discount*, while choosing 5 courses will grant you a 20% discount*!
Choose among these titles:
- Technology Transfer nel settore Farmaceutico – English training
- Ispezioni e Audit nel Farmaceutico
- Gestione dei risultati OOS e OOE/OOT
- Risk Analysis nel Farmaceutico
- Il Monitoraggio Ambientale nel Settore Farmaceutico
- Le Good Distribution Practices (GDP)
- La Convalida Analitica secondo ICH Q2
- Metodi Statistici per il Controllo Qualità
- APR, PQR e CAPA System
- Il Campionamento Ambito Farmaceutico
- Qualifica, Convalida di Processo e Cleaning Validation
- Inspection Readiness Documentale
- Investigational Medicinal Products: Aggiornamenti EU sugli IMPS
- La Convalida dei Metodi Microbiologici
- Studi di Stabilità nello Sviluppo Farmaceutico
- Ispezioni e Audit al Laboratorio QC Microbiologia
- RABS e Isolatori nella Produzione dei Farmaci Sterili
- Le Deviazioni Microbiologiche: Come Gestirle?
- Qualified Person: Giornate di Formazione
- Il Controllo Microbiologico nel Settore Farmaceutico
- Pharmaceutical Risk Assessment – English training
- BET – Bacterial Endotoxin Test
- Identificazioni Microbiche Ambientali
(*) discounts apply to the full prices of the courses and cannot be combined with other promotions.
The promotion is limited to enrolling the same person in 3 or 5 courses selected from those offered.
Register now
850€
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
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