Cleaning and cleaning validation - still current?

In the discussion: Dr.Axel ship man, F. Hoffmann La Roche AG and Cornelia WawretschekReinigung and cleaning validation to 5. - 6.Oktober in Binzen - proximity Basel Dr. Schiffmann, for three years are you in the team of the specialized moderators of the seminar cleaning and cleaning validation. What provokes you at this task? The topic lives much of practical exchange of experience, since the king way is not given in the various sets of rules. Contents with the auditory can be reflected and be adjusted by the annual presentation not least with the own knowledge, which makes personally very much fun for me. The FDA publication of the Guide ton of Inspections Validation OF Cleaning Processes, which took up the topic cleaning validation, appeared already 1993, and the seminar is held for more than ten years. Do you at all still consider the topic current? The topic is still very up-to-date, there the key word � Reinigungsvalidierung" in the different pharmaceutical branches of industry often with very different conceptions and objectives one understands and one converts. The active course participation, we saw with the last course again, seem the topicality besides to confirm. The approaches during the equipment cleaning are nevertheless surely in each company in writing fixed, and exactly the same it will be with the topic cleaning validation, or? How meaningfully still is the visit of such a seminar from your view? Surely each enterprise of the one permission must for the production of active substances and drugs possesses in sets of rules its interpretation and approach to the topic � Reinigungsvalidierung" described. Interestingly enough there are however very different possibilities the release for production equipment to give which not least also a different view of the willingness to take risks of the responsible persons reflects. I think the seminar am also as small forum to be understood, in which the different approaches and Risikoabsch�tzungen can be exchanged and confirmed within the group of participants.�What is the special at the meeting in Binzen? In the technology center of the company Glatt the theoretical and the practical work can be interconnected on the best. Beside the lecture-room it gives to be worked the premises in those in smaller groups can, besides take place the practical part of the Workshops at the different manufacture plants in the technology yardstick. As the further characteristic also the possibility exists a view of the entire process chain, beginning with the plant production of a high-grade steel sheet metal up to the GMP conformal drug production on the firm area to get for the participants.�With what is your lecture occupied?�In my lecture the seminar participants hear somewhat over those the development of a concept to the cleaning validation. My lecture is divided into several parts: First I touch the official requirements and contents to a cleaning validation. In the connection by a practical example the topic guidance substance determination from a matrix is lit up. Here by confrontation of different acceptance criteria the guidance substance as well as their limit value are determined and represented in the form of surface-related limit values. Apart from the view of active substance cleaning agents as well as the micro-biological arrears are likewise discussed. The substantial components of a validation plan as well as their conversion, those in a validation report flow are a component of a further chapter. As one with new active substances in particular in the hospital sample manufacturing for phase 1 and 2 to deal can at the end of the lecture for discussion is presented. Apart from your lecture the seminar participants experience somewhat over cleaning agents, suitable sampling procedures and analysis methods and over cleaning validation in the active substance production.�Is it sufficient to obtain these knowledge theoretically? Can the participants take up all this in two days?�No, naturally not. The two days have actually two substantial goals: To mediate the beginners in this topic the tool in form of a Handouts and train it practically. � the Auffrischern" and/or experienced professional the possibility to give by practical examples the own approach to analyze in particular by the constant and spontaneous exchange in the forum with the referenda and seminar participants. How do I have to imagine the practical work? It takes place a practical course at production plants for firm medicine forms in the technical school yardstick. Here you practice in small working groups and learn to identify the critical steps of a cleaning validation. �Does that mean that the organizers PTS training service turn only to enterprises, which manufacture firm medicine forms? No, the meeting is just as suitable for coworkers, who manufacture other medicine forms. Because all the same whether liquid, firmly or semisolid: the principles of the cleaning and cleaning validation are there applicable and the approach are similar. By the way this is valid also for packing procedures, also the packing concepts must be regarded critically. The meeting program makes a very extensive impression. �That is indeed like that, the program is comprehensive and varied and we expects that the seminar participants take part actively. We make sure however that sufficient time for the exchange of ideas remains and the participants to feel well. We made the experience the fact that us questions are placed, which address both the analyst and the manufacturer or which over the cleaning agents requires specialized knowledge. Therefore we find moderators it important that we are available on both days as much as possible, even if we do not hold a straight lecture. We pass on naturally also the practical experience, which we have all.�To whom would you recommend the seminar? All persons the cleaning methods, concepts develop for the cleaning and cleaning validation/verification provide and these care for /betreuen are and the exchange of ideas with colleagues of other enterprises to search, are this seminar recommended. Where do I find more information about the seminar? Topics and dates find you always up-to-date in the net under: http://www.pts.info/aktuell/themen.asp?p=244----------------------------------------------------

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