"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

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.

Gate2GMP®

When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
Watch this short video to learn more about what Gate2GMP® offers »

 

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Course facts

Course no:
5206
Industry:
Pharmaceuticals

Level:
Intermediate
GMP region:
US

Language:
English
Instructor:

Mr. John Y. Lee

Date, location and venue:

Preliminary May/June 2018, Copenhagen, Denmark


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

Price (excl. local VAT):
14 400 DKK (€ 1 925) incl. course material (pdf), lunches 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.

Discounts:
For groups registered and invoiced together we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
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.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
* If you still want a printed course handouts binder from us, we charge 50 Euro/pcs (of which 10 Euro to TRINE for clean energy projects)

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 7 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.