 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
Mr. John Y. Lee »
Next course:
May 25-26 2009, Prague, Czech Republic
Course Venue:
» Andel's Hotel & Suites Prague
Agenda:
Day 1: 8.30-17.00 Registration 08.00-08.30
Day 2: 8.30-17.00
Price:
€ 1.795 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. If for any reason a registered participant is unable to attend, substitution is always possible and preferred. All cancellations must be in writing (letter, fax or e-mail). Cancellations received less than 21 calendar days before course start are subjected to a service charge of 200 € + 100 €/course day (Euro). No refunds or credits are issued for failure to cancel or "no show". Courses may be cancelled by the organiser if bookings fail to reach minimum numbers. In such circumstances course fees will be refunded.
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.
Lundén/Ellow ab and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Phone: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com