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:: PROCESS ANALYTICAL TECHNOLOGIES (PAT): IMPROVING THE QUALITY OF DRUG PRODUCTS ::
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Posted by crash on Sunday, September 25, 2005 - 11:26 AM CONTINUING EDUCATION COURSES IN INDUSTRIAL PHARMACEUTICAL SCIENCE AND PRACTICE
EUROPEAN CONTINUING
COURSES FOR 2005
PROCESS ANALYTICAL TECHNOLOGIES (PAT): IMPROVING THE QUALITY OF DRUG PRODUCTS
A THREE-DAY INTENSIVE COURSE on THE EMERGING REGULATORY DEMANDS FOR IMPROVED DRUG QUALITY, FOCUSING on THE TOOLS REQUIRED TO IMPLEMENT PAT
28th, 29th and 30th November 2005, Kensington Park Hotel, Kensington, London, U.K. COURSE BACKGROUND AND OBJECTIVES To provide attendees with (1) a summary of the regulatory guidelines describing the move to PAT and away from conventional sampling approaches; (2) a detailed overview of the methods most likely to provide the information needed to make PAT a success; (3) a description of the mathematical tools used to interpret the data stream from these methods; and (4) lessons to be learned from other industries (e.g., those involved in production of processed foods, dietary supplements, herbal medicines, and agricultural products), who are already using some aspects of PAT. KEY BENEFITS OF ATTENDINGThe emphasis on ever improving quality is a continued theme for regulatory agencies around the world. The most recent guidelines call for companies to employ non-invasive or minimally invasive methods for continuous process monitoring, an approach they term process analytical technologies (PAT). The PAT approach would allow excursions from specifications to be identified sooner and to analyze a larger proportion of the actual samples. If this could be done, drug products with greater consistency and higher quality would result. This course will describe the most recent regulatory guidelines, the methods that currently exist to accomplish PAT implementation, and the mathematical methods required to evaluate such large data sets. Finally, lessons from other industries that employ PAT methods will be presented. At the end of the course, one should be fully versed on this emerging regulatory mandate, and be equipped to make intelligent decisions on the PAT strategy that makes sense for them. WHO SHOULD ATTENDAnyone involved in the development and manufacturing of any type of pharmaceutical product should consider attending. This would include those involved in research & development, quality control, quality assurance, fermentation, purification, formulation, and production. Those involved in overseeing these operations would benefit as well as those working at the bench or in the plant. This course will be beneficial for those involved in contract manufacturing as well as those producing their own products, whether they are generic or ethical products. Those involved in the manufacture of phytopharmaceuticals, vitamins, or dietary supplements would find it useful as well. All types of dosage forms will be discussed, including tablets, capsules, freeze-dried powders, liquids, microspheres, and topical preparations. COURSE OUTLINEIntroductionRegulatory Guidelines Concerning PATMathematical Tools for Interpreting PAT Data SetsNoninvasive Monitoring of Drug Product QualityNear Infrared (NIR) Spectroscopy Infrared Spectroscopy UV Absorbance Spectroscopy X-Ray Diffraction Biosensors Others Minimally Invasive Methods for Monitoring of Drug Product QualityCapillary Electrophoresis Mass Spectrometry Thermal Methods Others Lessons from Other Industries Using PAT MethodsProcessed Food Products Herbal Medicines Agricultural Products (grains, milk) LECTURER
Mark C. Neil Manning, Ph.D. Dr. Manning is Chief Scientific Officer for Legacy BioDesign LLC in the U.S.A. Previously, he was Chief Technical Officer at HTD BioSystems. Before that he held a position as Associate Professor of Pharmaceutics at the University of Colorado School of Pharmacy. He received his B.A. in Chemistry from Hope College and his Ph.D. in Inorganic Chemistry from Northwestern University. After postdoctoral work at Colorado State University, he joined the Department of Pharmaceutical Chemistry at the University of Kansas as Assistant Professor. In 1990, he joined the faculty at the School of Pharmacy at the University of Colorado Health Sciences Center, where he was co-founder and co-director of the University of Colorado Center for Pharmaceutical Biotechnology (a joint enterprise between the schools of pharmacy and engineering). He has published over 100 scientific articles, received four U.S. patents, and has co-edited three books in the series, Pharmaceutical Biotechnology. He has worked on a wide variety of formulation projects and drug delivery systems. His research interests include protein stabilization, drug delivery, and spectroscopy. Dr Manning has developed a very special interest in PAT and has lectured widely on the subject.
ABOUT THE COLLEGE The European Continuing Education College, is now well established worldwide as the leading provider of up-to-date, pragmatically orientated, relevant short courses for Managers, Scientists, Engineers and Technicians. The College specialises in Courses for the pharmaceutical, biotechnology and healthcare industries. These courses are tailor-made to the requirements of the industry and as a result provide information of tremendous benefit to those who may not necessarily be at the forefront of knowledge in a particular area. Over the years our pharmaceutical courses, under the Direction of Professor Mike Rubinstein, have proved extremely popular and are often heavily oversubscribed. This success is mainly due to the very careful selection of material and lectures for the Courses, to the provision of workshops, clinics, case studies and discussion sessions, to the very extensive course notes provided and to small group participation. Presenters are very carefully chosen from academia and the industry who are both experts and accomplished teachers and great care is taken to ensure that the Courses are right up-to-date and that there is proper integration of both the theoretical and practical considerations of the subject. All material is reviewed and assessed to make sure it is pertinent and relevant. Demonstrations, Case Studies and Workshops of actual pharmaceutical equipment, processes and methods are general features of most of the College courses. In addition most of our courses include problem solving sessions and recently the College has introduced E.C.E.C. Technical Clinics. Participants on our courses can let us know beforehand or bring with them, a particular problem or problems pertinent to the subject area of the course, which they would like advice about. This advice will be given either confidentially or more usually at a special open discussion session during the course, at which other participants can offer their advice and experience as well. The E.C.E.C.also provides tailor-made in-house courses for Pharmaceutical, Biotechnology and Healthcare companies. If you would like further details of our forthcoming Courses, please ask our Office to put you on our mailing list. If you require details of our in house course service, please contact our Office for more information.
FEES AND REGISTRATION The participation fee is £1255.00 (exclusive of VAT). Places are strictly limited and therefore applications will be accepted on a first come basis. Under UK law all applications are subject to Value Added Tax (VAT) irrespective of the country of origin of participants. Most VAT registered companies/organisations can reclaim this tax. The fee includes full personal participation, extensive bound course notes, luncheons and light refreshments, on all days of the Course. Dinner at night is not included. Cancellations cannot be accepted less than 14 days prior to the start of the Course, but substitutions may be made at any time. The Course language will be English. An approved Certificate of Attendance will be given to each participant at the end of the Course. TIMING OF THE COURSE Registration will be at 8.45am on Monday 28th November and the Course will commence promptly at 9.00am. The Course will finish at about 17.30 on Wednesday 30th November. The Course will end at about 18.00 on each of the first two days.
E.C.E.C. TECHNICAL CLINIC The College recognises that participants may have a particular problem or problems that they would like advice about. on this course participants are invited to send in beforehand (or bring with them) details of their technical problems, which will be considered by the lecturers. A special open discussion session has been timetabled on this course at which participants problems will be discussed and advice given. At this session other course participants can offer their advice and experiences as well. If you would like advice to be given confidentially, please advise the College beforehand. ACCOMMODATION A special room rate of £138.00 (normal rate £190.00) per night single with bathroom, inclusive of breakfast (£172.00 twin/double (normal rate £207.00)), exclusive of VAT, has been negotiated for participants on this Course at the superb 4 star luxury Kensington Park Hotel in fashionable Kensington. The Hotel is opposite Kensington Palace and is peacefully situated in De Vere Gardens, just off Kensington High Street. The Hotel is close to Hyde Park, the stylish shops of Knightsbridge (Harrods) and Kensington and the Royal Albert Hall. The West End, Buckingham Palace, Piccadilly Circus, Trafalgar Square and the Houses of Parliament, in fact almost every major attraction, is within easy reach. Nightlife is no problem with cinemas, restaurants, clubs and theatres all in the vicinity. The Hotel has numerous restaurants and bars. High Street Kensington Underground Station is a couple of minutes walk from the Hotel. DIRECTIONS
BY AIR: From Heathrow Airport the Heathrow Express should be taken to Paddington Station. This express train service operates every 15 minutes and the journey time is 15 minutes. once at Paddington Station in central London a short taxi ride can be taken to the Kensington Park Hotel off Kensington High Street. Alternatively the underground tube can be taken from Paddington directly to High Street Kensington (4 stops on the Circle or District line). once at High Street Kensington Underground Station the Hotel is a couple of minutes walk away. From Gatwick Airport take the train to Victoria and then either a taxi or the Underground (Circle or District Lines) 4 stops, directly to High Street Kensington. BY TRAIN: All the main line stations connect with the London Underground and participants can get the Underground to High Street Kensington. BY ROAD: Car parking facilities in Young Street are available nearby but it is expensive. HOW TO REGISTER-
To register please complete the registration form and forward with your payment to the: EUROPEAN CONTINUING EDUCATION COLLEGE 24 Menlove Gardens North, Liverpool L18 2EJ, U.K. Telephone:+44 (0)151 737 1993 Fax: +44 (0) 151 737 1070E-MAIL: REGISTER@ECEC.CO.UKWEBSITE: WWW.ECEC.CO.UK All applications will be acknowledged and a formal V.A.T. receiptissued. Telephone reservations (+44 (0) 151 737 1993) or better Fax (+44 (0) 151 737 1070) or E-Mail (REGISTER@ECEC.CO.UK) to the Courses Secretary will be provisionally accepted and confirmed on receipt of the form. REGISTRATION FORM PROCESS ANALYTICAL TECHNOLOGIES (PAT)IMPROVING THE QUALITY OF DRUG PRODUCTS 28th, 29th and 30th November 2005, The Kensington Park Hotel, Kensington, London, U.K.
Please charge to myq VISAq Mastercard/Eurocardq American Express Card Number ..Expiry Date .. Name on Card Signature .. EUROPEAN CONTINUING EDUCATION COLLEGE24 Menlove Gardens NorthLiverpool L18 2EJ, U.K. Tel: +44 (0) 151 737 1993Fax: +44(0) 151 737 1070E-Mail: register@ecec.co.uk www.ecec.co.uk
COURSES 2005/2006
FOR FURTHER INFORMATION PLEASE CONTACT Prof Mike Rubinstein Tel: +44 151 737 1993Fax: +44 151 737 1070 E-MAIL: INFO@ECEC.CO.UK WWW.ECEC.CO.UK24 Menlove Gardens North, Liverpool L18 2EJ, U.K.
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