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STEAM STERILIZERS Process Validation Specialist Course

Technical Training

  • #sterilization

The participants will learn how to select the proper validation methodology as well as the thermal and microbiological studies required during sterilization process validation. This knowledge will be applied to verify that the products meet the required sterility assurance level and to maintain the process in its validated state.

Content

  • Regulatory references for moist heat sterilization
  • Sterility assurance concept, D-values, z-values, F0 and their application
  • Cycle design: overkill approach versus product specific approach
  • Validation methods: overkill, bioburden/biological indicator, and bioburden-based methods
  • Physical and biological process performance qualification
  • Validation equipment (TCs, CIs, BIs): selection, placement and results interpretation
  • Analysis of a sterilization process printout
  • Ongoing process control

Duration

2 days

Target

QA personnel, validation specialists, sterility assurance specialists

Class size(min/max)

4-6 participants

Program

June 14

 

0830-0900Welcome & registration
Morning keynotes – Theoretical session
0900-1000 Introduction to validation
1000-1030 Thermal validation part 1
1030-1100 Coffee break
1100-1130 Thermal validation part 2
1130-1300 Biological validation
1300-1400 Lunch
Afternoon beakout groups – Practical session
1400-1530 Sterilization validation practical
1530-1545 Coffee break
1545-1630 Practical training in Tech Centre – Case studies & common loads
1630-1700 Q&A and closing remarks

June 15

0830-0900 Welcome & registration

Morning keynotes – Theoretical session

0900-1000 Thema4 overview

1000-1030 Coffee break

1030-1300 How to structure a cycle for different loads

1300-1400 Lunch

Afternoon beakout groups – Practical session

1400-1530 How to use the process controller to achieve goals in sterilisation

1530-1600 Coffee break

1600-1700 how to face a FDA warning letter

1700-1730 Q&A and closing remarks

When Trainers Where
March 9, 2017-Fedegari Tech Center USA
TBD-Fedegari Tech Center UK
March 23, 2017-Tech Center Italy

Fedegari Tech Center USA

Fedegari Tech Center UK

Tech Center Italy

Pre-register
When Trainers Where Choose
March 9, 2017-Fedegari Tech Center USA
TBD-Fedegari Tech Center UK
March 23, 2017-Tech Center Italy

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The price includes training led by an instructor, course literature, lunch and coffee. All prices are ex. VAT.

Registrations are binding.

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.

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.

The registration is preliminary until we've confirmed it.

Outcome

  • Select the validation methodologies according to load attributes
  • Define the “worst case” load
  • Perform physical and microbiological studies
  • Select, handling, D-value calculation of biological indicators
  • Demonstrate product sterility assurance level
  • Maintain process validation state
Request Info
When Trainers Where Choose
March 9, 2017-Fedegari Tech Center USA
TBD-Fedegari Tech Center UK
March 23, 2017-Tech Center Italy

First Name (required)

Last Name (required)

Company

Email (required)

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I authorize the use of my personal data in compliance with UE Regulation n.67/2016 on the protection of natural persons with regard to the processing of personal data (GDPR).

My details will not be communicated or disclosed to third parties , and I may require at any time, the access, the rectification, the erasure, the restriction, the portability and to object their use (according to Articles 15, 16, 17, 18, 20, 21) by sending an e-mail privacy@fedegari.com.