January 7-8, 2009 The Fairmont San Francisco, CA

Transcription

1 Special Goup Discounts ae Available Ceating GLP Stuctue fom the Gound Up Januay 7-8, 2009 The Faimont San Fancisco, CA The couse will povide detailed infomation and the cuent state-of-the-at knowledge on must know topics such as witing SOP s, the do s and don ts fo the GLP audit, and Quality Assuance. Ample time is allocated to each speake in ode to povide an inteactive, in-depth tutoial with time fo questions, detailed coveage of the subject and discussion of individual poblems and situations. The audience will be stongly encouaged to inteact, bing poblems, discussion points o suggestions in ode to bainstom with the expets and shae new infomation. You will be povided with pinted handouts to follow along with the speakes and take notes. Witing SOP s Dealing with Regulations Documentation, Validation and Qualification In depth coveage Q&A Addessing You Poblems Pinted Couse Mateial Oganized by: Cambidge Healthtech Institute 250 Fist Ave, Suite 300, Needham, MA T: o Toll-fee in the U.S F:

2 Day One 8:00 am Registation and Moning Coffee Witing SOP s 8:30 11:50 Witing SOP s (20 minute coffee beak included) Compliance with the equiements of a Good Laboatoy Pactice (GLP) Study Potocol can only be achieved if the analytical methods and othe study conduct opeations ae popely descibed in witten Standad Opeating Pocedue (SOP) documents. Failue to have adequate study documentation and SOPs shows up fequently in FDA waning lettes to institutions having GLP compliance poblems. This semina will povide attendees with essential tools fo the job of ceating a compliant SOP system. It will cove: How to develop an effective SOP and wite clea, pactical instuctions How to set up you SOP pocess so employees know who s esponsible fo what and how often to eview and update pocedues The details to include and avoid when dafting a SOP Steps fo monitoing and auditing SOP compliance Alex D. Kanaek, Ph.D., Pincipal, AK Consulting D. Alex Kanaek, Pincipal of AK Consulting, has moe than 30 yeas of expeience in the biophamaceutical industy with the Wellcome Foundation (now GlaxoSmithKline) in the UK and Connaught Laboatoies (now Sanofi Pasteu) in Noth Ameica. He established his consulting pactice in 1993, specializing in egulatoy compliance in dug development laboatoies and manufactuing plants, technology tansfe and biophamaceutical poduct development. D. Kanaek has witten Guides to Good Laboatoy Pactice, Good Manufactuing Pactice, Good Validation Pactice, Good Clinical Pactice and to Good Facility Design. He is on the editoial advisoy boad of the BioPocess Intenational Jounal. D. Kanaek eceived his B.S. in Micobiology fom Impeial College, Univesity of London, his Ph.D. on Vius Reseach fom Cambidge Univesity and Membeship (MCIM), in Intenational Phamaceutical Business Development, fom the UK Royal Chateed Institute of Maketing. 11:50 1:40 pm Luncheon, povided by CHI 1:40 5:00 Dealing with Regulations (20 minute efeshment beak included) Planning and Conducting an Audit How to Audit Effectively Define: fist paty, second paty, thid paty audits; significance. Defining audit objectives; standad(s) o citeia against which the audit is to be conducted. Audit pocess document audit, system audit, pocess audit. Audit planning developing audit checklist; objective vs fequency and schedule. Pe-audit meeting communication. Audit findings obsevations (oppotunity fo impovement), mino nonconfomance, majo nonconfomance. What ae they? How to addess them? End of the Audit meeting; initial communication o peliminay epot of audit findings. Communication exchange between audito and auditee. Final epot. Follow-up actions: pupose and pocedue. Lokesh Bhattachayya, Ph.D., Cetified ISO/IEC Lead Assesso, Intedisciplinay Scientist/Quality Manage, Division of Poduct Quality, Office of Vaccine Review and Reseach, Cente fo Biologics Evaluation and Reseach, Food and Dug Administation I woked fo 9+ yeas ( ) in Meck and Co. as a lead analytical biochemist esponsible fo planning, pioitizing, conducting, and documenting studies to povide analytical suppot fo vaccines and biotechnology-deived Ceating poteins GLP unde Stuctue cgmp. I have 6+ yeas expeience in leading and managing the standad setting activities of the US Phamacopeia ( ) in diffeent fom the Gound Up capacities, including the Diecto of the Noncomplex Actives (phamaceutical dugs) and Excipients Division in the Dept. of Standads Development. At pesent, I am a staff of the Division of 2

3 Poduct Quality (DPQ) of the Office of Vaccine Review and Reseach (OVRR), Cente fo Biologics Evaluation and Reseach (CBER) of the US Food and Dug Administation (FDA) since August, I seved as the Validation Manage until Novembe 2007 and as the Quality Manage since July I was a faculty at the Albet Einstein College of Medicine, New Yok ( ), and obtained his Ph.D. (1983) fom Calcutta Univesity, India. I published seveal oiginal eseach papes and eview aticles in pee-eviewed jounals and pesented in seveal confeences. Disclaime: This pesentation epesents the tuto s opinion and not the position of the FDA. 5:00 End of Day One Day Two 8:30 10:00 glp bioanalysis Peequisite and Requiements fo GLP-Bioanalysis Establish GLP Bioanalytical Lab Develop Bioanalytical Methods Validate Bioanalytical Methods unde GLP Regulations Pefom GLP-Bioanalysis in egulated envionment Couse will pesent mateial fom conducting GLP-bioanalysis in moden state of the at bioanalytical facility opeating unde industy highest standads and pactices. Couse paticipants will gain inside knowledge into woking pocedues of GLP-bioanalysis in suppot of IND-enabling and clinical studies and thei impact on dug development pogam Eckhadt Schmidt, Ph.D., Pincipal Scientist, Clinical Phamacology and DMPK, AstaZeneca Phamaceuticals LP D. Eckhadt Schmidt eaned his Ph.D. in chemisty at Philipps Univesity/Gemany and attended Kansas and PennState Univesity fo postgaduate eseach. D. Schmidt has held senio scientist and manageial positions with contact eseach oganizations and majo phamaceutical companies at Riceca Biosciences, IVAX, Metabais Theapeutics and AstaZeneca. His poven tack ecod of 13 yeas has povided a unique hands-on pespective on bioanalytical applications. He has been ecognized by poblem solving and extensive accomplishments in to suppot dug discovey effots. D. Schmidt manages at AstaZeneca the GLP LC/MS/MS laboatoy by developing and validating methods and oveseeing bioanalysis to delive nonclinical, in vito and clinical studies. His wok expeience include dose-anging, elative bioavailability and dug dug inteaction studies on small molecules in a high-thoughput envionment. Documentation, Validation and Qualification 10:00 11:30 am Building a GLP Compliant Business fom the Goup up - Avoiding Common Pitfalls Ray l. Nunnally, Ph.D., Invivometics 11:30 11:45 Coffee Beak 11:45 1:15 pm Cuent Tends in Bioanalytical Method Validation o Validation of Computeized Systems - A Risky Business? Cuent equiements/pocess: Method development/validation Setting up a method validation potocol Update on the Cystal City equiments Method tansfe/evalidation - how to Cuent tends fom the OECD o Pime on validation of computeized systems - equiements by the GLPs GAMP5, PIC/s and othe guidelines Red Apple II - cuent concepts fo validation of computeized systems FDA, 21 CFR Pat 11and the isk based appoach The tutoial gives a compehensive way an up-to date pictue of method validation and validation of computeized systems in a GLP setting. Attendees will be able to implement and use the concepts and pinciples associated with bionalaytical method validation and validation of computeized systems in thei own GLP envionments. Wolfgang Seidel, Ph.D., MRQA, Head of QA DMPK, MSR Nonclinical Development, Meck KGaA D. Seidel eceived his Ph.D. in food chemisty and has 8 yeas of expeience in seveal QC/QA functions in the biotech/phamaceutical industy Cuently head of QA fo the GLP test facility DMPK Meck KGaA Membe of the BARQA, DGGF, GDCh and DGQ Speake at vaious national/intenational CSV/GLP confeences. 1:15 End of Couse 3

4 Hotel Infomation SAN FRANCISCO, CA The Faimont San Fancisco Hotel 950 Mason Steet San Fancisco, CA Tel: Fax: Discounted Room Rate: $219 s/d Discounted Resevation Cutoff: Decembe 5, 2008 To eseve you hotel oom please call the hotel diectly and ask fo the Cambidge Healthtech Institute goup ate. Resevations made afte the cut-off date o afte the goup oom block has been filled (whicheve comes fist) will be accepted on a space-and-ate-availability basis. Rooms ae limited, so please book ealy. Tavel Infomation Flight Discounts: To eceive a 5% o geate discount on all Ameican Ailine flights please use one of the following methods: Call (authoization code A4819SS). Go online at (ente A4819SS in pomotion discount box). Contact ou designated tavel agent, Wendy Levine, at ext Ca Rental Discounts: Special discount entals have been established with AVIS fo this confeence. Please call AVIS diectly at and efeence Avis Woldwide Discount (AWD) Numbe J o go to Goup Discounts available Discounts will be deducted fom total egistation fees. 3-5 people fom the same oganization... 20% eduction 6-9 people fom the same oganization...25% eduction 10 people and above...30% eduction Oganizations wishing to egiste multiple employees, fo any of the GLP couse dates, please contact Rose LaRaia at o laaia@healthtech.com to eceive an invoice/pay by check. Sponsoship and Exhibit Oppotunities This is an outstanding oppotunity to netwok with scientists needing to wok accoding to GLP egulations. These scientists wok in all segments of the eseach maket including phamaceutical, biotech, academic, and govenment. The Cambidge Healthtech Institute offes an aay of sponsoship packages and exhibit space fo you to each this tageted audience. Make a lasting impession as a thought leade by taking advantage of these maketing tools. Fo additional infomation, please contact Angela Pasons by phone: o apasons@healthtech.com Media Patnes 4 4

5 YES! Registe me fo Registation Infomation M. Ms. Ms. D. Pof. Ceating GLP Stuctue fom the Gound Up Januay 7-8, 2009, The Faimont, San Fancisco, CA Yes! I would like to eceive a FREE enewslette subsciption to: The latest industy news, commentay and highlights fom Bio IT Wold The pemie ennews souce on technology fo healthcae Innovative management in clinical tials 840 F Goup Discounts Available Name Job Title Company Addess City/State/Postal Code County Telephone Div./Dept. Discounts will be deducted fom total egistation fees above. 3-5 people fom the same oganization...20% eduction 6-9 people fom the same oganization...25% eduction 10 people and above...30% eduction Fax * * is not a mandatoy field. Howeve, by excluding you you will not eceive notification about online access to peconfeence pesente mateials, confeence updates, netwoking oppotunities and equested enewslettes. How would you pefe to eceive notices fom CHI: Yes No FAX: Yes No PRICING Infomation Fill out the appopiate picing section fo the couse date/location you would like to attend: Commecial Academic, Govt., Hosp.-Related Registe me fo the Januay 7-8, 2009, San Fancisco, CA GLP Couse Ealy Registation Discount until Octobe 17, 2008 $1295 $875 Advanced Registation Discount until Decembe 5, 2008 $1445 $945 Registations afte Decembe 5, 2008 $1645 $1045 Please send infomation on exhibiting and oppotunities to pesent wokshops. Payment Infomation Enclosed is a check o money ode payable to Cambidge Healthtech Institute, dawn on a U.S. bank, in U.S. cuency. Invoice me, but eseve my space with cedit cad infomation listed below. Invoices unpaid two weeks pio to confeence will be billed to cedit cad at full egistation ate. Invoices must be paid in full and checks eceived by the deadline date to etain egistation discount. If you plan to egiste on site, please check with CHI befoehand fo space avail ability. Please chage: AMEX (15 digits) Visa (13-16 digits) MasteCad (16 digits) Oganizations wishing to egiste multiple employees, fo any of the GLP couse dates, please contact Rose LaRaia at o laaia@healthtech.com to eceive an invoice/pay by check. CHI insight Phama Repots A seies of epots that evaluate the salient tends in phamaceutical technology, business, and theapy makets. Keep abeast of the latest advances in phamaceutical R&D, thei potential applications and business impacts, and thei cuent and futue position in the maketplace. Fo a list of epots, visit Insightphama.com, o contact Rose LaRaia, laaia@healthtech.com, Additional Registation Details Each egistation includes confeence session, food functions and a copy of the confeence mateial. Goup Discounts Special ates ae available fo multiple attendees fom the same oganization. Contact David Cunningham at to discuss you options and take advantage of the savings. Handicapped Equal Access In accodance with the ADA, Cambidge Healthtech Institute is pleased to aange special accommodations fo attendees with special needs. All equests fo such assistance must be submitted in witing to CHI at least 30 days pio to the stat of the meeting. Cad # Cadholde Signatue Cadholde s Addess (if diffeent fom above) City/State/Postal Code County Exp. Date Substitution/Cancellation Policy In the event that you need to cancel a egistation, you may: Tansfe you egistation to a colleague within you oganization Cedit you egistation to anothe Cambidge Healthtech Institute pogam Request a efund minus a $100 pocessing fee pe confeence NOTE: Cancellations will only be accepted up to two weeks pio to the confeence. Please efe to the Keycode below: Pogam and speakes ae subject to change. Video and o audio ecoding of any kind is pohibited onsite at all CHI events. FAX o MAIL you egistation to: Cambidge Healthtech Institute 250 Fist Avenue, Suite 300, Needham, Massachusetts T: o Toll-fee in the U.S F: