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Validation and Qualification Compliance Requirements

 

Industry field:

Pharmaceutical industry

 

Course description:

This course reviews the GMP compliance requirements for validation and qualification studies, and the latest FDA interpretations of these GMP requirements. This course also reviews the current compliance issues such as revalidation and requalification, qualification of existing equipment, process analytical technology and the FDA’s 2008 draft revision of the guidance for process validation. The topics for review and discussion include GMP requirements and interpretations, process validation, installation and operation qualifications, cleaning validation, computer validation, and the preparation of the validation protocol and report.

 

Course outline:

 

Day 1

• GMP Review and Interpretations for Validation and Qualification Studies
   - Current GMP and FDA requirements for validation and
     qualification studies
   - Performance qualification versus process validation
   - Interpretation and application of design qualification, FAT and SAT
   - Conditions and limitations for retrospective and concurrent
     validation studies
   - Objectives and contents of master validation plans and related records
• Preparing the Validation/Qualification Protocols
• Compliance Requirements for Installation Qualification
• Compliance Requirements for Operation Qualification

 

Day 2

• Process Analytical Technology
• FDA Draft Revision: Guidance for Process Validation
• Compliance Requirements for Process Validation
• Compliance Requirements for Computer Validation
• Compliance Requirements for Cleaning Validation
• Preparing the Validation/Qualification Report

 

Learning objectives:

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.

 

Who should attend:

This course is suitable for professionals with a basic or advanced knowledge of GMP/FDA requirements and compliance issues for validation and qualification. The information and practical examples presented in this course will benefit quality professionals with responsibilities for validation compliance and auditing; and validation, engineering and production professionals with responsibilities for the execution of the validation/qualification studies, and the preparation of related records.

 

 

 

Course facts

Course No:

5206
Instructor:

Mr. John Y. Lee
Next course:

October 2011.

Contact us for more information.
Course venue:

-
Agenda:

Day 1: 8.30-16.30
( Registration 08.00-08.30)
Day 2: 8.30-16.30
Price:

€ 1.895 incl. course material, lunches and refreshments
Discounts:

We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements.
Cancellation policy:

Registration is binding and when you have received our confirmation the following conditions are know and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.

All cancellations and/or substitutions must have been communicated with and confirmed by us.

Cancellations received less than 21 calendar days before course start are subjected to a service charge of 200 € (Euro). Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.

Courses may be cancelled by the organizer if bookings fail to reach minimum numbers, and in such circumstances course fees will be refunded, or granted to attend another course for the same value. We are not responsible or liable to any costs in conjunction with a cancelled course. Under normal conditions a cancellation decision is taken +6 weeks prior the course start.
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