"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
GMP Compliance and Auditing
for Sterile Pharmaceuticals
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.
- Sterile Product Processing Controls; Facilities and Equipment Design
- Aseptic Gowning and Aseptic Techniques
- Sterilization Parameters: Practical Application of F, D and Z Values, Including Class Exercises
- Designing, Validating and Revalidating Sterilization Cycles
- Clean Rooms
- Design and Classification, HEPA Filter Testing
- Particulate Monitoring, Air Pressure Differential, Air Flow
- 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
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.
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.
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4.8 of 5
"Very instructive training and educational course leader."
"Just, what I needed to know about sterile manufacture."
"Good examples of how to apply in practise."
Pharmaceuticals, Final dosage form
Intermediate / Advanced
Mr. John Y. Lee
Date, location and venue:
Preliminary Nov/Dec 2018, Copenhagen Denmark
Day 1-2: 8.30-16.30 (Registration 08.00-08.30, day 1)
Day 3: 8.30-12.00 + Lunch
17 900 DKK (€ 2 395) 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.
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.
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.
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.