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Compliance Seminars®

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.

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

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 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.

Course outline:

  • 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

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.


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Course facts

Course no:

GMP region:


Mr. John Y. Lee

Date, location and venue:
3-4 December 2020, Copenhagen, Denmark
Tietgensgade 65    
(Entrance from Kvægtorvsgade)

Register by 22 October - Save 1 500 DKK (€ 200)

Specify our booking code D000030870 to get a discount when making a reservation at a Scandic Hotel.
Scandic Hotels nearby:
» Scandic Webers (500m)
» Scandic Kødbyen (800m)
» Scandic Copenhagen (800m)

2 days
8.30-16.30 (Registration 08.00-08.30, day 1)

Price (excl. local VAT):
Register by 22 Oct and save 1 500 DKK (€ 200)
Up to 22 Oct: 13 780 DKK (€ 1 850)
From 23 Oct: 15 280 DKK (€ 2 050)
incl. course material (pdf), lunch and refreshments

Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.

For groups registered and invoiced together for the same course we offer the following quantity discount:
3 persons or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.

Course material (Handouts)  
No printed course material will be provided on our courses*.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
3-5 days prior the course you will receive a download link for the course handouts as a PDF.
Note pads and pens will always be provided at the venue.

Cancellation policy - Compliance Seminars®  

Cancellation of registration:

Registration is binding and when you have received our confirmation the following conditions are known 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 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 14 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.

Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.