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Validation and Qualification Compliance Requirements

Key2Compliance®
2 dage
Kursus
København
15.280 DKK ekskl. moms

Hvorfor vælge Key2Compliance® ?

Markedsleder - Kvalitetsbevidst og med certificeret kompetence

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God atmosfære med kooperative og tilgængelig undervisere

Kursusbeskrivelse

gmp

Validation and Qualification Compliance Requirements

This course reviews the GMP compliance requirements for validation and qualification, and the latest FDA interpretations of these GMP requirements and issues. This course also reviews current compliance issues, such as revalidation and requalification, qualification of existing equipment, and provisions for validation/qualification matrixing and bracketing.


Course outcome

The objectives of this course are to provide the attendees with an updated review of the latest GMP requirements and FDA interpretations for validation and qualification, and practical recommendations for the most effective and efficient methods to achieve a satisfactory level of compliance.


Course description

The topics for review and discussion include process validation, installation and operation qualifications, validation documentation, cleaning validation and computer validation.

The course will touch upon these topics:

  • GMP Review and Interpretations for Validation and Qualification
    • Current GMP and FDA requirements
    • Performance qualification versus process validation
    • Interpretation and application of commissioning, design qualification, FAT and SAT
    • Conditions and limitations for retrospective and concurrent validations
    • Objective and preparation of master validation plans and related records
    • Worst-case, and bracketing and matrixing
    • Current compliance issues
  • FDA Process Validation Guidance Revision (Jan. 2011): Review of selected topics
  • Preparing the Validation/Qualification Protocols
  • Compliance Requirements for Installation Qualification
  • Compliance Requirements for Operation Qualification
  • Compliance Requirements for Process Validation
  • Compliance Requirements for Computer Validation
  • Compliance Requirements for Cleaning Validation
  • Preparing the Validation/Qualification Report

When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.

Målgruppe

This course is suitable for professionals with a basic or advanced knowledge of GMP/FDA requirements and compliance issues for validation and qualification. The course will benefit Quality professionals with responsibility for validation compliance and auditing; and Validation, Engineering and Production professionals with responsibilities for the execution of the validation/qualification, and the preparation of related records.

Pris

Price of this course is 15.280 dkk excl. VAT.

Early bird price: 13.780 dkk excl. VAT.

Om udbyderen

Key2Compliance® er et uafhængigt internationalt netværk, der tilbyder kurser og produkter til forskellige funktioner i Life Science-branchen, fra udvikling til marked med hensyn til kvalitetssystemer og GMP-overholdelse.  Ved at hjælpe organisationer med at imødekomme GMP / QS-forventninger, forbedre arbejdsstyrkens viden...


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Kontaktinfo

Key2Compliance®

Tietgensgade 65
1704

Telefon: +46 (0)8 544 811 60

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