Cleaning Validation Seminar for Pharmaceuticals Industry With Iris Shamir

Gstudy > Courses and seminars > Cleaning Validation Seminar for Pharmaceuticals Industry With Iris Shamir

Mar 24, 2025

By Iris Shamir, M.Sc.

מחזור 3

Quality

Engineering & Validation

Location: Frontal

Starts at: 09:00

Duration: 1 Meeting

Language: Hebrew

The seminar will review the regulatory requirements and guidelines of cleaning validation lifecycle.
In the seminar we will learn about examples of authorities observations, how to avoid common mistakes and practice.

The topics of the seminar:

  • Details of the regulatory requirements
  • The lifecycle of cleanliness verification
  • How to calculate the cleaning limits
  • Risk management for worst-case selection
  • Validation of the analytical method
  • Microbiological considerations in cleaning
  • Validation of cleanliness of biotechnological products
  • Examples of comments from regulatory authorities
  • How to avoid common mistakes
  • Case study practice

Seminar date - 24/03/2025
Seminar Hour's - 09:00-17:00
Location: Building 22 Matam Park, Haifa

Registration Fees:

  • Early Bird Rate (until March 19, 2025): 1,300 NIS + VAT
  • Standard Rate (starting March 20, 2025): 1,500 NIS + VAT

Secure your spot at the discounted rate before the price increases!

  • About Iris Shamir, M.Sc.

    More than 20 years of experience in the pharmaceutical Industry in various Management QA, Compliance and QC roles.Leading sites to successful FDA and other Authorities inspections. Medical Device and combination products experience. Strong leadership and change Management capabilities.Former GMP Inspector at the Pharmaceutical Israeli GMP Inspectorate (ISCP, Israeli Ministry of Health).

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