09:30 – 12:30 Morning Session 14:00 – 17:00 Afternoon Session Program Regulatory references Operational and documentary approach Case studies with supporting videos Deviations found during pharmaceutical inspection

Smoke studies in contamination-controlled environments

2° EDITION: 4 March 2025

Online

Italian

Training overview

Smoke studies are critically important tests that visualize air flows within contamination-controlled environments. Airflows can be vehicles of contamination and have serious repercussions on the sterility of the finished product: identifying and characterizing them correctly is therefore crucial.

This training course on smoke studies will teach you how to best define a procedure to perform proper airflow visualization and analysis in contamination-controlled environments.

Key points of the training

Know the main guidelines
Define an appropriate verification procedure
Resolve or manage any plant and process limitations

Program

09:30 – 12:30 Morning Session
14:00 – 17:00 Afternoon Session

Program

Regulatory references
Operational and documentary approach
Case studies with supporting videos
Deviations found during pharmaceutical inspection

Suitable for

Quality Assurance, Qualification, Engineering, Production.

Methodology

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.

Payment

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

Donatello Somma

Validation Manager at C&P Engineering

Donatello Somma is Quality and Qualification Manager of C&P Engineering, a consultancy and services company in the chemical pharmaceutical industry sector: engineering for GMP and validation services, general and strategic consultancy, organizational analysis, evaluation and optimization of services, project coordination integrated, organization of maintenance. Previously he held numerous positions of responsibility in the pharmaceutical industry until 2005, when he left the position of Head of Corporate Validations in the A. Menarini srl group.

Interested in Pharma Engineering & Validation?

Enroll in 3 courses and you’ll get a 15% discount*!
Choose among these titles:

(*) 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 courses selected from those offered.

Register now

Early Bird 10%

Within 2 months before the start of the training

760€

850€

Early Bird 5%

Within 1 month before the start of the training

800€

850€

Full price

850€

Training edition

Ticket type

Clear

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

Environmental Monitoring in the Pharmaceutical Sector

In the pharmaceutical industry, especially in sterile production, environmental monitoring (EM) of classified areas and utilities plays a fundamental role [...]