• Σταδίου 61, Αθήνα 10451
  • 210-5200106
  • Δευτ - Παρ. (09:00 - 19:00)

CLEANING VALIDATION

CLEANING VALIDATION

NEW SPECIAL ON-LINE SEMINAR

DATES & TIME

Monday 05 July 2021 16:00-20:00
Tuesday 06 July 2021 16:00-20:00

CLEANING VALIDATION

Speaker

WALID EL AZAB
Senior Manager Technical Services at STERIS
Working with global pharmaceutical manufacturers. He provides technical support related to management, manufacturing, quality, QP decision, inspection readiness, and compliance. He performed several audits at suppliers and manufacturers’ sites. He is also known as a trainer, a coach and a consultant of QA, validation and QP people. Also, he is an active and board member at several pharmaceutical industry associations and a University lecturer – Universite libre de Bruxelles. Finally, he is a recognized expert in the contamination control field.

Who should attend
The seminar is addressed to Executives of Pharmaceutical companies involved in departments of:

  • R&D
  • Production
  • QA / QC
  • QP
  • Maintenance

 

TOPICS  PER DAY

  • Introduction to cleaning validation
    • Global Regulatory requirement for cleaning validation

 

  • Cleaning Cycle design and processes
    • Cleaning cycle design for manual or automated cleaning
    • Identify worst case residue
    • Identify worst case location

 

  • Equipment design
    • Best engineering practices
    • Common failure observed

 

  • Cleaning validation limit calculation and consideration
    • Residue limit calculation (PDE, MACO, etc.)
    • Setting microbial limit
    • Sampling methods and choice

 

  • Cleaning monitoring
    • Routine monitoring
    • Requalification

 

  • Visual inspection challenges:
    • Current practices
    • Visual inspection only
    • Setting visual residue limit
    • Visually clean criteria
    • Technology in pepeline

 

  • Surface monitoring and specific for indirect product contact surfaces
    • Current practices
    • Define the control to put in place

 

  • Q&A
·          CONTACT DETAILS:  Foteini Chatzipanteli /   TEL: +0030 210 5200106, 211 0131884 – E-MAIL: education@oikonomotexniki.gr

 

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  • Simi Seminars LTD
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    NEW SPECIAL ON-LINE SEMINAR DATES & TIME Monday 05 July 2021 16:00-20:00 Tuesday 06 July 2021 16:00-20:00 CLEANING VALIDATION Speaker...