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GMP Compliance and Auditing for Sterile Pharmaceuticals

Key2Compliance®
3 dage
Akademiuddannelser
København
18.989 DKK ekskl. moms

Hvorfor vælge Key2Compliance® ?

Markedsleder - Kvalitetsbevidst og med certificeret kompetence

Flere leveringsløsninger og nem adgang til viden - Fleksibilitet

God atmosfære med kooperative og tilgængelig undervisere

Kursusbeskrivelse

This course reviews and interprets the current FDA compliance requirements for the production and control of sterile pharmaceuticals, and discusses the practical techniques for conducting an effective and efficient audit.

Course description:

The topics selected for this course include the GMP compliance requirements for various aseptic processing controls; a compliance and technical review of aseptic filtration, lyophilization technology, and HVAC and WFI systems; and the current compliance issues for isolator technology, media fill, and microbiological environmental monitoring.

Course outline:

  • Sterile Product Processing Controls; Facilities and Equipment Design
  • Aseptic Gowning and Aseptic Techniques
  • Sterilization Parameters: Practical Application of F, D and Z Values, Including Class Exercises
  • Designing, Validating and Revalidating Sterilization Cycles
  • Clean Rooms
    • Design and Classification, HEPA Filter Testing
    • Particulate Monitoring, Air Pressure Differential, Air Flow
  • Microbiological Monitoring for Sterile Operations
  • Disinfection and Sanitization (D&S) Programs
  • Aseptic Filtration
  • Media Fill: Validation Requirements and Recommendation
  • Water-for-Injection Systems
  • Lyophilization Technology
  • Isolators

Learning objectives:

This course will provide the attendees with the GMP compliance and technical knowledge to evaluate the controls for sterile pharmaceuticals and ensure compliance with FDA requirements.

Målgruppe

Who should attend:

This course is intended for Compliance Auditors, Quality Assurance and Production professionals. Regulatory Affairs and Research and Development professionals involved in the support for sterile pharmaceuticals should also attend.

Pris

Price: 18 990 DKK

Early Bird price: 16 760 DKK

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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