Training

Innovation in chemical bio-decontamination:

from the process to the machine

This course provides a deep understanding of vaporized hydrogen peroxide technologies, processdevelopment and validation with biologicalindicators (BIs). Following practical sessions at themachines, by the end of the course trainees will beable to develop and run a decontamination process, manipulate BIs and calculate system D-value.

Who should attend?

The course is intended for individuals involved with or who are considering the use of vaporized hydrogen peroxide technology. It is appropriate for personnel working in QA, regulatory affairs, production, engineering, validation, and microbiology.

Where?

Fedegari Technology CenterAlbuzzano (PV), Italy

Two editions:

September 29-30, 2015 October 1-2, 2015

Your trainers

Garrett KrushefskiMesa Labs

James Agalloco

Agalloco &Associates

SerenaAmbrosini

FedegariGroup

&

M. LuisaBernuzziFedegari

Group

Education

Learn more at: fedegari.com

DAY 10900 0930 Registration

0930 1100 Introduction to vaporized HO processes (J. Agalloco)

Comparison of different processes and equipment

Decontamination technologies on the market

Re-circulating non-condensing systems

Re-circulating condensing systems

Re-circulating wet systems

Fill and Soak

Other decontamination technologies

Generators self-contained

1100 1130 Coffee break

1130 1230 Overview of Fedegari system (S. Ambrosini)

Scale of the project

Design features

1300 1400 Lunch break

Parallel sessions (2 groups x 5 people)

1400 1530 BIs (Session1) (G. Krushefski)

Differences from other BIs

Wrapped / Unwrapped

Controls during BI production

BI selection / Relative resistance of G. Stearothermophilus

1530 1600 Coffee break

1600 1730 Fedegari system demonstration (Session2) (L. Bernuzzi)

Run a cycle: empty chamber with BIs

1730 1800 Panel discussion

DAY 2

0900 1000 Regulatory references (J. Agalloco)

1000 1030 Coffee break

Parallel sessions (2 groups x 5 people)

1030 1300 BI handling & testing (Session 1a ) (G. Krushefski)

System D-value calculation

Manipulation and storage

Tricks & tips

Anomalous BI results

Process development and PQ (Session 1b) (J. Agalloco)

1300 1400 Lunch break

1400 1500 Fedegari system demonstration (Session 2) (L. Bernuzzi)

Run a cycle: full load

1500 1530 Coffee break

1530 1700 Fedegari system demonstration (Session 2) (L. Bernuzzi)

Run a cycle: full load

1700 1730 Panel discussion and closing remarks

Fedegari Technology Center Albuzzano (PV) - Italy T+39 0382 434111 F +39 0382 434150

TRAINING & EDUCATION Innovation in Chemical Bio-decontamination

DM#381391 21/5/15

Registration Form (use a separate page for each attendee)

_________________________________________________________________________ Mr. □ Ms. □ Dr. □ First Name Last Name _________________________________________________________________________ Job title Company _________________________________________________________________________ Work Address _________________________________________________________________________ Country Zip/Mail Code City _________________________________________________________________________ Phone E-mail Dates Attending & Course Fee

□ September 29th – 30th, 2015 / Registration fee: € 2,000*

□ October 1st – 2nd, 2015 / Registration fee: € 2,000* * Second and subsequent attendee(s) from same company/institution receives a 30% discount Payment & Registration

□ By Bank Transfer (net without any charges) to the following account:

IT21K0503411301000000001512

□ By Credit Card (2% charge will be added to the registration fee) Cardholder name ________________________________________ Card number __________________________________________ Expiration date, MM/YY _________________ CVC Code ____________ You will not be registered, unless payment is received. Please, register within September 12th and return the completed form by email to: training@fedegari.com

Meals Lunch is included in the course fee.

□ Vegetarian meals (available, if requested with registration) Cancellations Course fees are fully refundable, if written notice is received up to 3 weeks prior to the start of the course. After that, cancellations will be refunded less a 30% service fee. Cancellations received within 7 days prior the beginning of the course are not refundable.

TRAINING & EDUCATION Innovation in Chemical Bio-decontamination

DM#381391 21/5/15

In case of course cancellation, Fedegari’s responsibility is limited to refund the received fees. Substitutions Substitutions are accepted without penalties. Please, inform before the beginning of the course. Accommodations Transportation, accommodation and other expenses are at care of the attendee. We do not book accommodations for attendees. Fedegari recommends:

Hotel Moderno (www.hotelmoderno.it) is located close to the main railway station of Pavia and near the pedestrian area of the city centre; it is a good choice if you want to have a walk in the historic part of Pavia but it can be a bit noisy due to the location. Double room single use € 125,00 – B&B accomodation

Hotel Resort Cascina Scova (http://www.cascinascova.it/en/index.php) is a very quiet hotel

on the outskirt of town with swimming pool and gym facilities located approximately 3 km from there to the city center. Double room single use € 100,00 – B&B accommodation.

If you need any help, please do not hesitate to contact us at: training@fedegari.com.