Factorytalk is very pleased to invite you to a seminar on Quality Management for PICS, what is required today and coming compliance developments

Transcription

1 7 th January 2014 Dear Sir r Madam, Factrytalk is very pleased t invite yu t a seminar n required tday and cming cmpliance PICS requires the tightest f cntrl n the fundamental regulatins cvered by a Quality Management System. Management persnal f pharmaceutical manufacturers must be active and are directly respnsible t maintain an effective and functinal QMS, this is cnsidered a key aspect f PICS GMP. The tpics that will be cvered during the event include: Cmpnents and structure f a well-established Quality Management System (QMS) Hw t incrprate risk assessment as part f yur QMS and what yu d Effective training management and recrds Cntrl f critical dcumentatin required t supprt drug manufacture The tracking and cntrlling f prductin and quality events such as CAPA The management f internal and external audits Perfrming regular quality reviews including Annual Prduct Review This event will prvide expert speakers, presentatins and systems t explain the cncepts and demnstrate actual case studies and supprting systems t satisfy PICS requirements The event will interest Owners and Senir Managers frm QA, QC, Regulatry, Prductin and Engineering invlved in pharmaceutical manufacturing wh need t ensure that their cmpanies can meet the latest inspectin standards and cming trends in the industry. Factrytalk, headquartered fr ten years in Thailand has executed 100 s f successful assignments and prjects in ver 15 cuntries acrss the US, Eurpe and Asia. Factrytalk prvides bth reginal and internatinal Pharmaceutical and Bitech manufactures with a suite f cmpliance services and tls t ensure that best practices are built in t yur rganizatin and are sustainable.

2 SEMINAR required tday and cming cmpliance Grand Atelier Rm(4 th Flr), Le Méridien Bangkk Thank yu fr taking the time t read this letter. We lk frward t hsting yu t ur event and please d nt hesitate t cntact us in case yu have any questins. Yurs sincerely, David Margetts, Managing Directr

3 AGENDA required tday and cming cmpliance Grand Atelier Rm (4 th Flr), Le Méridien Bangkk Welcme and Intrductin Mr. David Margetts Overview f Quality Management Systems fr PICS cmpliance Ms. Chmpunut Apinan - Relevant PICS requirements fr: Risk Assessment Annual Prduct Review Dcumentatin Batch Recrd Management Submissins Management - Hw t structure yur Quality Management System Risk Assessment Dr. Anthny Margetts - What is Risk Assessment and hw t manage it accrding t PICS - Intrductin f the Risk Assessment Case Study Risk Assessment case study Cffee Break Annual Prduct Review Ms. Chmpunut Apinan - Understanding the PICS Annual Prduct Review requirements - Intrductin f the Annual Prduct Review Case Study Annual Prduct Review case study Lunch Break Batch Recrd Management Mr. David Margetts - Overview n the PICS Batch Recrd requirements - Best practices and lean pprtunities in Batch Recrding - Intrductin f the Batch Recrd case study Batch Recrding case study Cffee Break Submissins management: an update n esubmissins in Thailand Mr. Teerapng Cheepchl Q&A and Wrap-up - Intrductin t the Thai FDA esubmissins initiative

4 SPEAKERS BIOGRAPHY MR. DAVID MARGETTS BIO David Margetts is the Managing Directr and C-Funder f Factrytalk and acts as a trusted Advisr and Cnsultant t the Pharmaceutical and Bitech industries. He versees a widely experienced and rapidly grwing business and team f experts wh apply cmpliance, technlgy and peratinal imprvement slutins int practice acrss Asia, US and Eurpe. Margetts technical backgrund spans shp flr cntrl thrugh manufacturing executin t the crprate level fr the applicatin f peratinal excellence and regulatry cmpliance initiatives. MR. TEERAPONG CHEEPCHOL BIO Teerapng Cheepchl is the Deputy Managing Directr f Factrytalk and leads prject teams and assignments acrss all areas f drug manufacture, regulatin and distributin. Cheepchl is a highly seasned executive with large and critical prject experience acrss Asia, Eurpe and the US including fr: West Pharmaceutical Systems, Nvartis, Bayer, Merck-Sern, MSD, Dr Reddy s, Jhnsn & Jhnsn and Astra Zeneca. Cheepchl manages and steers entire prject implementatins and hlds ISPE Trainer certificatin. DR. ANTHONY MARGETTS BIO Dr Tny Margetts is Factrytalk s Cmpliance Manager. During the 1990 s he managed the intrductin f new wrld-wide validatin prcedures and was the Chairman f a UK Pharmaceutical Industry Grup charged with writing a Guideline n Cmputer Systems Validatin which evlved ver a number f editins and expanded frm UK thrugh Eurpe, USA and Japan and is nw called the Gd Autmated Manufacturing Practice (GAMP) Guide. Dr Margetts was chairman fr the editrial review f the latest versin f the GAMP series, GAMP 5, published in 2008 which is cnsidered the wrld reference fr Cmputer Validatin fr the Regulated Industries. He has als been invlved in prducing several f the GAMP/ISPE gd practice guides including A Risk Management Apprach t Cmpliant Electrnic Recrds and Signatures. MS. CHOMPUNUT APINAN BIO Ms. Chmpunut Apinan is a Senir Cmpliance Cnsultant at Factrytalk and Prject Manager including fr the first MasterCntrl eqms implementatins in Thailand. Apinan has a great depth and range t her expertise and has led cnsulting assignments in all areas f supprt fr PIC/S cmpliance and als hlds key technical and quality rles in the implementatin f Factrytalk s large scale IT prjects. Apinan previusly wrked as an Analyst fr Advanced Inf Systems PLC and as a grup leader in Quality Assurance fr Ajinmt Ltd. She hlds a Masters in IT frm KMUTT University Thailand and Bachelrs in Bitechnlgy frm Mahidl University Thailand

5 SEMINAR required tday and the cming cmpliance Grand Atelier Rm (4 th Flr), Le Méridien Bangkk Register nline at r fill and return this frm t: Ms.Rawadee and Ms.Jutamas cntact@factry-talk.cm r fax t REGISTRATION FORM Please cmplete ne frm fr each registrant PLEASE USE BLOCK LETTERS Title (Prf, Dr, Mr, Mrs, etc) Full Name Psitin Organisatin Address Telephne Facsimile Mbile WHO SHOULD ATTEND Owners and Senir Managers frm QA, QC, Regulatry, Prductin and Engineering invlved in pharmaceutical manufacturing wh need t ensure that their cmpanies can meet the latest inspectin standards and cming trends in the industry. TERMS & CONDITIONS Please fill in and return this frm n later than 3rd February 2014 Reservatins are n a first cme, first serve basis. This seminar is FREE OF CHARGE; a maximum f 2 peple per cmpany may register. Cancellatin plicy: All cancellatins must be nticed within 7 wrking days prir t the seminar day