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Pharmaceutical industry
"From 2000 to 2010 around 35% of the "Warning Letters" from the FDA contained remarks on cleaning and cleaning validation!
The state of control regarding our cleaning processes is a constant issue by our regulators. Beyond purely "compliance" issues, it is a major point for control of the manufacturing process. This course is intended for manufacturers of final dosage pharmaceuticals, active pharmaceutical ingredients, and intermediates, as well as for biotech companies and R&D.
This course is constantly updated according to state of the art and the changing CGMP expectations, focused on the aspects of technical and regulatory (US and EU) updates associated with validation of cleaning processes. The course content is based on the cross-over experiences of Mr. John Lee (former FDA investigator) and Mr. Frédéric Laban (senior international consultant) on the subject, particularly on the most recent statements from the FDA, the recommendations of SFSTP and APIC; and the current EU GMPs.
The course will provide the attendees with a better knowledge of regulatory requirements and techniques to be able to build their own cleaning validation strategy in accordance with current US regulations and to get the most effective “payback” in terms of productivity, safety, ergonomics and environment protection.
Using examples and practical exercises in groups, linking together techniques, quality assurance and compliance with FDA/EU requirements. At each step, the regulations are recalled and interpreted into operational and achievable recommendations.
Recognition of bad practices, definition of the golden rules of cleaning
GAP-analysis between US and European regulatory expectations
The prerequisites for the validation
Definition of specifications
Qualification of material and chemicals
Qualification of personnel
Definition of cleaning validation, general methodology
How to build up its own strategy, optimizing the “payback” in addition to the GMP compliance
Calculations of acceptance limits
Sampling methods
Analytical methods
Various strategies, methods of grouping and "worst case"
Monitoring, change control and revalidation
At the end of this course the participants will have acquired the knowledge necessary for the rational and compliant implementation of a cleaning validation program for manufacturing equipment on pharmaceutical or chemical sites, from clinical to manufacturing batches.
Feedback from participants:(4.3 of 5) "Very good course with a lot of group work that was informative and gave ideas" "It was good to have lot of “challenges” to talk about, good to activate attendants" "Very nice course. Good lecturer. Easy to keep concentrated" "The course was great! " |
Course No:5220 |
Instructors: |
Next course:June 12-13, 2012 |
Course venue: |
Agenda:Day 1 & 2: 8.30-17.00 (Registration 08.00-08.30 day 1) |
Price:€ 1295 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 and when you have received our confirmation the following conditions are know 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 21 calendar days before course start are subjected to a service charge of 200 € (Euro). Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full. Courses may be cancelled by the organizer if bookings fail to reach minimum numbers, and in such circumstances course fees will be refunded, or granted to attend another course for the same value. We are not responsible or liable to any costs in conjunction with a cancelled course. Under normal conditions a cancellation decision is taken +6 weeks prior the course start. |
Lundén/Ellow ab and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Tel: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com
(4.3 of 5)