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and Laboratory Operations
Mr. John Y. Lee »
Next course:
October 26-27, 2009, Copenhagen, Denmark
Course Venue:
» IDA Mødecenter, Copenhagen
Agenda:
Day 1: 8.30-16.30 Registration 08.00-08.30
Day 2: 8.30-16.30
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 requirements, and their interpretation and application to quality control chemistry and microbiology laboratory operations. The topics include the essential laboratory systems, programs and procedures, the current GMP compliance issues, and the FDA’s expectations for laboratory systems and controls.
Course outline:
• USP Interpretations
• Walk-through Inspection Coverage
• General GMP Requirements and Laboratory Controls
- Samples, reagents and reference standards
- Instrument calibration, maintenance, qualification and logbooks
- Investigations and change control
- Personnel qualification and training
- Stability program
- Raw material reduced testing program
- Retention sample program
• Microbiology Laboratory Controls
- Media control and media growth promotion, sterility testing, methods validation
• Laboratory Procedures and Documentation
- SOPs, raw data, electronic records
• Laboratory Data Integrity Case Studies
• Analytical Method Validation
• Laboratory OOS: Investigations and Retesting
Who should attend:
This course is intended for the Quality Control, Quality Assurance and Compliance professionals who are directly involved with laboratory operations, or responsible for the compliance and auditing of laboratory systems and controls. The information in this course may be beneficial for Regulatory Affairs professionals who are responsible for FDA submission.
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