ࡱ> gif'` Q\bjbj &cDDDDDDDdd< 2hNNNN)1|@C1E1E1E1E1E1E1$t3h5i1]D"))""i1DDNN1h%h%h%"DNDNC1h%"C1h%h%V-@DDq.N e37F#- C110 2-x6$6q.q.v6D.\h%4i1i1%X 2""""d  DDDDDD RoseTECH Consulting, Inc. GLP Training for Study Directors One-Day Workshop Instructor Celeste Rose, RQAP-GLP October 29, 2009 Cleveland, Ohio Attendance will be limited. This workshop is a small group interactive training event designed to provide attendees with a sound understanding of GLPs. It goes beyond a reiteration of the regulations and delves into the fundamental principles and practices of Good Laboratory Practices. Examples are incorporated throughout the workshop to demonstrate how the GLP standards and principles are put into action dealing with real-life trials and tribulations which are encountered in non-clinical lab studies. Participants will gain a thorough understanding of the GLP requirements and responsibilities of the Study Director role, as well as soft skills and writing skills which are key for effective quality study conduct. This session will cover study compliance and the importance of good documentation, effective writing, and most importantly study reconstructibility. Agenda ( HYPERLINK \l "description" full description on next page) GLP Roles and Responsibilities of Study Directors Study Conduct Embracing the GLP Mindset Good Documentation and Study Reconstructibility Effective Writing of Protocols, Amendments, Deviations, and Study Reports Workshop Exercises and Q&A Who Should Attend: Study Directors and Principal Investigators Study Personnel who may become Study Directors or Principal investigators Managers/QA professionals, who wish to gain an increased understanding of Study Director role & GLP responsibilities Course Objectives: Gain a greater understanding of GLP regulations that apply to GLP roles and responsibilities Locate citations pertaining to specific GLP requirements Learn how to effectively and compliantly execute quality GLP studies Generate quality, compliant study protocols, study file documentation, reports Apply newly learned skills and knowledge to problem-solving, mitigation, and prevention RoseTECH Consulting, Inc. GLP Training for Study Directors One-Day Workshop Instructor Celeste Rose, RQAP-GLP October 29, 2009 Cleveland, Ohio Attendance will be limited. Workshop Content GLP Roles and Responsibilities of Study Directors Overview of FDA/EPA/ and OECD Good Laboratory Practice Standards with a focus on the regulatory requirements and responsibilities of a GLP Study Director & Principal Investigator. In addition to technical and regulatory qualifications, several other skills important for effective study direction will be covered. Study Conduct Embracing the GLP Mindset This session takes a different approach to learning and understanding the GLPs. There are basically six fundamental principles of GLP Control/Accountability; Clear Study Design/Objectives; Prevention of Contamination, Mix-up or Deterioration; Data Quality & Integrity; Accurate Results/Conclusions; and ultimately RECONSTRUCTIBILITY. Acknowledgement of the premises of GLPs fundamental principles lays the foundation to allow us to incorporate GLPs instinctively into our everyday functions. Good Documentation and Study Reconstructibility Reconstructible documentation is imperative to the quality and compliance of a GLP study. This section will cover quality documentation including protocols, amendments, deviations, raw data and study documentation, and final reports. Effective Writing of Protocols, Amendments, Deviations, and Study Reports Clear, concise writing is a key to study reconstructibility. This section will cover protocol, protocol amendment, and report writing and effective documentation of deviations and unexpected circumstances, with a focus on writing for the reader. This will include technical writing helpful hints and report organization skills to produce well-written documents. Workshop Exercises and Q&A Workshop exercises will be presented to challenge the participant to apply newly learned knowledge of the principles of GLP. FDA Warning Letter and 483 Findings will be presented throughout the workshop. RoseTECH Consulting, Inc. GLP Training for Study Directors One-Day Workshop Instructor Celeste Rose, RQAP-GLP October 29, 2009 Cleveland, Ohio 8:00 4:00 p.m. $500/attendee - includes continental breakfast, lunch, breaks, and workshop materials. Print this form and send by mail, e-mail (pdf), or fax with payment. Participants Name: FORMTEXT       Title: FORMTEXT       Company: FORMTEXT       Adress: FORMTEXT       City/State/Zip: FORMTEXT       Phone:  FORMTEXT       Email: FORMTEXT        FORMCHECKBOX  Study Director  FORMCHECKBOX  New Study Director (<1 year)  FORMCHECKBOX  To Be Study Director  FORMCHECKBOX  Principal Investigator/Contributing Scientist  FORMCHECKBOX  Management  FORMCHECKBOX  QA  FORMCHECKBOX  Other _________________________ Payment Method  FORMCHECKBOX  Bill Me (PO# required) FORMTEXT        FORMCHECKBOX  Check Enclosed (mail to): RoseTECH Consulting, Inc. 1185 Waterfront Place, Painesville, Ohio 44077 Send Bill To Name: FORMTEXT       Title: FORMTEXT       Company: FORMTEXT       Adress: FORMTEXT       City/Stat2<=MNqrӽmXD3!h056B* OJQJaJph3'hCjh056B* OJQJaJph3(h0h05B* CJOJQJaJph3(hCjh^w5B* CJ OJQJaJ ph3"hCj5B* CJ OJQJaJ ph3+hp hCj56B* CJ0OJQJaJ0ph3%hp 56B* CJ8OJQJaJ8ph3+hp hCj56B* CJ8OJQJaJ8ph3+hp h^w56B* CJ8OJQJaJ8ph3+hCjhCj56B* CJ0OJQJaJ0ph3 Nr  M % @ T d hgdp  & F h(hd ](^hgdCj & F h(hd x](^hgdCj d hgdp d gdCjgd^w $<a$gd0 $xa$gdCj$a$gdCjSP\ m r   ɷtt`N<"h_ h05>*OJQJ^JaJ"h_ hCj5>*OJQJ^JaJ&hp h+.5CJOJQJ\^JaJhp CJOJQJ\^JaJhp hCjCJOJQJ\aJ#hp hCjCJOJQJ\^JaJ#hp h+.CJOJQJ\^JaJ#hp h&hCJOJQJ\^JaJ!hCjh&h56>*OJQJaJ!h0^56B* OJQJaJph3'hCjh0^56B* OJQJaJph3  + , - 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