Conducting a Risk Assessment for Non-Sterile Facilities E-Workshop

Transcription

1 Micrrite, Inc. brings yu this unique learning experience in Cnducting a Risk Assessment fr Nn-Sterile Facilities; Part f Micrrite s step-by-step E-Wrkshp series. Cnducting a Risk Assessment fr Nn-Sterile Facilities E-Wrkshp It is recgnized that there are n clear regulatry guidances fr micrbial cntrl in the manufacture f nnsterile pharmaceutical prducts. Thugh nn-sterile prducts are allwed a certain level f biburden, the risk t them is n less impactful than t sterile prducts. Objectinable micrrganisms can cause infectin r harm via mde f administratin when intrduced int the patient. Perfrming a micrbial risk assessment at every step is crucial, frm facility design t prduct release. Additinally, understanding the clinical implicatins f rganisms present in the prduct is essential t ensure patient safety. When? Nvember 17 th & 18 th, :30am t 12:30pm Eastern Standard Time Which industries des this E-Wrkshp apply t? Pharmaceuticals, Bitechnlgy, Medical Device, In Vitr Diagnstics, and Fd industry Wh shuld attend? QA, Micrbilgy, Manufacturing, Material Management, Facilities, Validatin, Regulatry, and Training Persnnel Wh will be teaching? Ziva Abraham, a knwn micrbial cntaminatin cntrl expert and a trained myclgist, has educated the industry n fungal identificatin fr ver a decade. Her understanding f the rigin and behavir f mld makes her a well-respected investigatr fr mld cntaminatins. She is the President and Funder f Micrrite, Inc., a Califrnia based cnsulting firm. She has ver 25 years f academic, research, clinical, and industrial experience in micrbilgy and quality assurance. Ziva has received her Master s Degree in Micrbilgy with a fcus n Myclgy and has wrked n develping micrbial insecticides using entmgenus bacteria and fungi fr her dctral research. Her career als includes funding and managing clinical labratries fr Maccabi Medical in Israel. She has trained persnnel frm varius industries in micrbilgy techniques and methds. She uses her extensive experience t teach why assessing risk f micrbial cntaminatin shuld be in the frefrnt f any cmpany that has prducts fr human/veterinary use. Her experience in clinical labratries has prvided her with the framewrk t understand the effects f micrbial cntaminatin in prducts frm a patient safety perspective. Micrrite fcuses n helping cmpanies with cntaminatin cntrl, micrbilgical quality cntrl fr sterile and nn-sterile manufacturing, quality assurance, and validatin. Micrrite, Inc New Trier Avenue + San Jse, CA Ph: Fax: w w w. m i c r r i t e. c m

2 Cnducting a Risk Assessment fr Nn-Sterile Facilities Part-1 Nvember 17 th, 2016 Day 1 will cver the level f micrbial cntaminatin risk in each type f nn-sterile prduct. The level f cntaminatin risk dictates the level f cntrl that will be required in terms f facilities and utilities. Part 1 f this E-Wrkshp will include: Level f micrbial cntaminatin risk in each type f nn-sterile prduct What is required t be tested vs. what is really bjectinable Guidance and recmmendatins fr perfrming a micrbilgical assessment fr a nn-sterile facility Learn abut the varius industry guidances impacting nn-sterile prducts and risk assessment Cnsideratin during design f nn-sterile prduct facilities, flws, and gwning requirements Understand the difference between classified vs cntrlled areas Explre cmmissining, validatin, and certificatin ptins fr nn-sterile facilities Cmprehend the imprtance f persnnel and material flws Cleaning and disinfectin cannt be ignred; understand why certain rganisms shuld be eliminated frm the facility fr certain prducts Learn hw t chse gwns and establish gwning prcedures fr different nn-sterile peratins Develping micrbial cntrl in utilities Understand t what extent utilities shuld be cntrlled, with regard t direct and indirect prduct cntact Knw prduct requirements befre setting specificatins Grasp testing frequencies fr water and gases Utilize risk assessments t set limits and frequencies Micrrite, Inc New Trier Avenue + San Jse, CA Ph: Fax: w w w. m i c r r i t e. c m

3 Cnducting a Risk Assessment fr Nn-Sterile Facilities Part-2 Nvember 18 th, 2016 Day 2 will cver the level f cntaminatin cntrl required in raw materials, and prcess. Risk based envirnmental mnitring and science based cleaning will be discussed. Part 2 f this E-Wrkshp will include: Managing micrbial lad in prcess Learn hw t set risk based incming material specificatins Ascertain hw t define and mnitr critical cntrl pints in the prcess Explre strategies fr setting in-prcess biburden levels Cleaning, disinfectin, and cleaning validatin Separate myths frm facts related t facility cleaning and disinfectin Learn t utilize envirnmental mnitring data t evaluate facility cleaning and disinfectin Use risk based and a lifecycle apprach fr designing yur cleaning validatin prgram Envirnmental mnitring Establish a risk based mnitring prgram t identify sites, frequencies, and micrbial characterizatin Understand which rganisms in yur facility, prcess, and prduct are bjectinable t patient and at what level Evaluate yur antimicrbial efficacy test by understanding the nature f yur facility, prcess, and prduct biburden Micrrite, Inc New Trier Avenue + San Jse, CA Ph: Fax: w w w. m i c r r i t e. c m

4 REGISTRATION FORM Cnducting a Risk Assessment fr Nn-Sterile Facilities Persnal Infrmatin f One Registrant Last Name: Mr. Ms. Dr. First Name: Jb Title: Organizatin: Mailing Address: Telephne: Fee: (see fee structure belw) $450 per persn Methd f Payment: Credit Card and Check payments nly. Attendees can register and make payments n Micrrite s website- r cmplete this frm and fax t Check payments must be cleared befre the webinar date. If yu have any questins regarding payment methds feel free t cntact Micrrite at r send yur enquiry t inf@micrrite.cm. Cnfirmatin f registratin will be sent via . Fr credit card payment n website, a payment receipt will be cnsidered as cnfirmatin f registratin. Fr credit card infrmatin faxed t Micrrite an cnfirmatin will be sent with a cpy f payment receipt. Please call in due time if cnfirmatin is nt received after payment. Webinar cancellatin must be received 3 business days prir t the E-Wrkshp less a 10% service fee, cancellatin requests will be accepted via nly. All refund requests must be made by the rganizatins primary cntact r credit card hlder. Refunds will be credited t the riginal credit card used t purchase the E-Wrkshp. Micrrite, Inc New Trier Avenue + San Jse, CA Ph: Fax: w w w. m i c r r i t e. c m

5 Cnducting a Risk Assessment fr Nn-Sterile Facilities Additinal Attendees First and Last Name Micrrite, Inc New Trier Avenue + San Jse, CA Ph: Fax: w w w. m i c r r i t e. c m

6 Cnducting a Risk Assessment fr Nn-Sterile Facilities Chse One (Place X) VISA Master Card American Express Card Hlder s Name Address f Card Hlder: Enter firm address fr crprate card r persnal address fr persnal card Street: City/State: Zip Cde: Cuntry: Cntact Ph N & Card Number: Expiratin(Mnth/Year): Amunt (US Dllars): Signature: Name f Attendee(s) Referred by: Kindly nte the name f the cmpany r persn that referred yu t this wrkshp. We wuld like t thank them.. Micrrite, Inc New Trier Avenue + San Jse, CA Ph: Fax: w w w. m i c r r i t e. c m