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GMP Compliance Auditing

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

GMP Compliance Auditing

Although quality and compliance auditing is not specifically required by drug GMPs, it has been an integral element of many pharmaceutical operations. The FDA has always expected self-audit programs and has criticized companies for failing to conduct such audits. 


Course outcome

Attendees will gain practical knowledge in establishing an effective GMP compliance audit program and auditor training program. They will learn practical skills for conducting GMP compliance audits, and know what to look for when conducting audits of various pharmaceutical operations. They will be familiar with the audit tools that are available to them. Attendees will also have a chance to review and discuss current GMP compliance issues.


Course description

This course will discuss some of the practical and proven techniques for conducting effective audits of various pharmaceutical operations, to identify the critical deficiencies associated with GMP compliance and product quality.

The course will touch upon some of these topics:

  • Compliance Audit Program
  • FDA/GMP Requirements and Audit Focus for Contractors
  • Auditor Training and Audit Tools
  • General Compliance Auditing
    • Raw material control
    • Weighing and dispensing
    • Manufacturing controls
    • Packaging and labeling controls
    • Calibration and maintenance programs
    • Quality assurance programs
  • Auditing Chemical/Biological APIs
  • Auditing Validation and Qualification Studies
  • Auditing Purified Water Systems

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

Målgruppe

This course is intended for professionals who are responsible for GMP Compliance and Auditing, at both the beginner and advanced levels. Production and Quality professionals will benefit by learning the potential problem areas so that appropriate actions can be taken. Regulatory professionals who are responsible for FDA inspections and contact should also attend.

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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