 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
5303 GMP Compliance and Auditing for
Sterile Pharmaceuticals
Sterile Pharmaceuticals
Instructor:
Mr. John Y. Lee »
Next course:
October 21-23 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
Day 3: 8.30-12.00 + Lunch
Price:
€ 2.295 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.
Mr. John Y. Lee »
Next course:
October 21-23 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
Day 3: 8.30-12.00 + Lunch
Price:
€ 2.295 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 and interprets the current FDA compliance requirements for the production and control of sterile pharmaceuticals, and discusses the practical techniques for conducting an effective and efficient audit.
The topics selected for this course include the GMP compliance requirements for various aseptic processing controls; a compliance and technical review of aseptic filtration, lyophilization technology, and HVAC and WFI systems; and the current compliance issues for isolator technology, media fill, and microbiological environmental monitoring.
Course outline:
• Sterile Product Processing Controls
• Sterilization Parameters: Practical Application of
F, D and Z Values, Including Class Exercises
• Designing, Validating and Revalidating Sterilization Cycles
• Environmental Requirements for Clean Rooms
• Microbiological Monitoring for Sterile Operations
• Disinfection and Sanitization (D&S) Programs
• Aseptic Filtration
• Media Fill: Validation Requirements and Recommendation
• Water-for-Injection Systems
• Lyophilization Technology
• Isolators
Learning objectives:
This course will provide the attendees with the GMP compliance and technical knowledge to evaluate the controls for sterile pharmaceuticals and ensure compliance with FDA requirements.
Who should attend:
This course is intended for Compliance Auditors, Quality Assurance and Production professionals. Regulatory Affairs and Research and Development professionals involved in the support for sterile pharmaceuticals should also attend.
Pharmaceutical industry
Course description:
This course reviews and interprets the current FDA compliance requirements for the production and control of sterile pharmaceuticals, and discusses the practical techniques for conducting an effective and efficient audit.
The topics selected for this course include the GMP compliance requirements for various aseptic processing controls; a compliance and technical review of aseptic filtration, lyophilization technology, and HVAC and WFI systems; and the current compliance issues for isolator technology, media fill, and microbiological environmental monitoring.
Course outline:
• Sterile Product Processing Controls
• Sterilization Parameters: Practical Application of
F, D and Z Values, Including Class Exercises
• Designing, Validating and Revalidating Sterilization Cycles
• Environmental Requirements for Clean Rooms
• Microbiological Monitoring for Sterile Operations
• Disinfection and Sanitization (D&S) Programs
• Aseptic Filtration
• Media Fill: Validation Requirements and Recommendation
• Water-for-Injection Systems
• Lyophilization Technology
• Isolators
Learning objectives:
This course will provide the attendees with the GMP compliance and technical knowledge to evaluate the controls for sterile pharmaceuticals and ensure compliance with FDA requirements.
Who should attend:
This course is intended for Compliance Auditors, Quality Assurance and Production professionals. Regulatory Affairs and Research and Development professionals involved in the support for sterile pharmaceuticals should also attend.
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