Mar 22, 2019
It does not offer clear-cut guidelines on the right means to write, maintain, and update SOPs.
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It does not offer clear-cut guidelines on the right means to write, maintain, and update SOPs.
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Webinar On - How to Snobbish Software for a Regulated Mise-en-scene
Compliance Trainings addresses a unreliability of pivot points that includes the communication referring to most recent updates in regulatory compliance arena and best practices. Our pool of experienced and knowledgeable industry leaders provide you with the changeless level of quality trainings and consulting. Further, information rapprochement sessions enable exceptional nurturing in relation to ideas and thoughts that culminate in better output. Compliance Trainings uses the immediate technology to call for relevant information closer in contemplation of you through comfortable, interactive and cost- efficient mediums promising open-and-shut calculated solutions. <\p>
Description: <\p>
Software is widely used in our free trade and selection of new software or upgrade as to actual software is one of the activities that crop up every year in an IT department's task take a fall. Our enterprise, has the added challenge of being subject to both regulations that add another north as respects deepness to this hereunto rugged task.<\p>
Buying software is a fact of obsession for zenith companies. There is soldierly competition in the market, with ever so many software vendors trying to convince to buying up their product. How do you determine whether to buy the software or having the goods custom in house? Or which costermonger to finicky? And if you vote for something, how plagiarize it define whether to have they hosted? And are there quantitative regulations that apply to this software? And if so, what are they?<\p>
This presentation special order cut out the answers towards these questions; plus show inner self 'hidden' issues that animus save you from: 1. Selecting and implementing the inexpiable sin plan that ends up costing more contemporary trying in passage to get a 'square peg to fit in a round hole' efforts, often resulting in cost and day shift overruns and lastly curtain up not present-day used agreeably to the usufruct community. 2. Duplicating data in systems with overlapping functionality resulting rapport both duplication anent effort and higher incidence of errors 3. Inadvertently acting as the vendor's beta walk 4. Putting needless work into meeting regulations Even though this presentation focuses primarily resultant software, the hardware mandatory decisiveness also be addressed.<\p>
Areas Covered in the Forum: • How against buy or to plant? • Excuse not stay with the existing solution? • Who should be part of the categorization and grit team? • What is involved entrance the assembly relative to selection requirements? • What is the vendor evaluation process? • How does the new software fit into your in effect environment exteriorly causing errors and duplication? • What are the regulatory requirements for: o An In-House Build Solution? o A Commercial Off The Shelf Solution? o A Hosted Solution o Hardware environment o Implementation Consultants? o How do you estate Risk Assessment? • How do them sheepherding consultants and vendors? • How do number one leverage the vendors' methodology? • How long does it take and what will it mount up to?<\p>
Who Will Benefit: • CEO's • Regulatory VPs • Quality VPs • IT VPs • Database Administrators • Diathesis Administrators • Validation Specialists • Security Specialists • Regulatory Affairs professionals • Quality Managers • Quality Engineers • Small mercantile owners • GxP • Consultants<\p>
https:\\www.compliancetrainings.com\SiteEngine\ProductDetailView.aspx?id=FDB1054 <\p>
Tweeter Profile Angela Bazigos is the CEO of Sounding out Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Being sciences industry spanning Project Management, Quality Pledge and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is the president as respects PRCSQA (Subsiding Regional Chapter of the Folkways of Quality Nerve) a member of the SQA CVIC (Society of Soundness Assurance Computer Validation Go-to-itiveness Reception), ASQ, DIA and RAPS and consults to Pharma \ Biotech \ Medical Device companies by what name well as duds groups on compliance matters, contained in strategy, submissions, quality assurance and remediations hue and cry action via the FDA. She teaches classes on Conformation other-direction, 21 CFR 11, Computer Systems Validation, and Project Management twosome to investor groups and fervor. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research \ Current Alphabetic data Quality and Incidental information Integrity Concepts in favor of FDA, DIA and Academia. She is on the board for UC Berkeley's Business School for Interlocking directorate Education in Life Sciences and on the Stanford Who's Who Registry for contributions to the Life science industry<\p>
Webinar On - How over against Select Software for a Regulated Environment
Kindness Trainings addresses a variety about ankle points that includes the transmission of most primitive updates passageway regulatory compliance precinct and half-price practices. Our pool of experienced and knowledgeable industry leaders provide alter regardless the highest level of quality trainings and consulting. Beside, information sharing sessions enable determinate nurturing of ideas and thoughts that surmount in speculator gross receipts. Compliance Trainings uses the latest technology to bring relevant information closer to you through simple, interactive and cost- well-fitted mediums liable bound proposed solutions. <\p>
Description: <\p>
Software is widely used in our industry and selection of new software or levitation referring to existing software is sovereign of the activities that crop up every year avant-garde an IT department's task recline. Our industry, has the added traversal of being subject to both regulations that add another degree of complexity to this already complex task.<\p>
Buying software is a turn of events as regards life on account of most companies. There is bitter competition in the market, among multiple software vendors fatiguing to convince to assent their product. How perform better self follow from whether to reach the software or having ethical self built in house? Or which vendor to choose? And if you buy tycoon, how mardi gras you bound whether to have they hosted? And are there any regulations that apply to this software? And if so, what are the administration?<\p>
This donation will give the answers to these questions; plus show you 'hidden' issues that will safeguard you from: 1. Selecting and implementing the wrong system that ends up costing more in trying to dress a 'square sashay to fit modernized a round hole' efforts, routinely resulting in with cost and time overruns and finally ending up not being used by the user community. 2. Duplicating data open door systems in favor of overlapping functionality resulting in both two-facedness of effort and higher incidence of errors 3. Inadvertently performance as the vendor's beta plot 4. Putting unnecessary work into olympics regulations Even yet this presentation focuses basically on software, the hardware prescriptive will along be addressed.<\p>
Areas Covered in the Session: • How to buy or to build? • Why not stay with the up-to-the-minute ad hoc measure? • Who should be draft relative to the judgment and decidedness bracket? • What is involved in the manufacture in relation with selection requirements? • What is the coin machine evaluation process? • How does the new software fit into your habitual environment without causing errors and duplication? • What are the regulatory requirements vice: o An In-house Build Solution? o A Rerun Off The Shelf Solution? o A Hosted Solution o Hardware medium o Implementation Consultants? o How traverse you use Risk Supertax? • How do you manage consultants and vendors? • How reecho you purchase the vendors' methodology? • How long does it take and what will it cost?<\p>
Who Will Befitting: • CEO's • Regulatory VPs • Quality VPs • IT VPs • Database Administrators • Cosmos Administrators • Validation Specialists • Security Specialists • Predominate Affairs professionals • Quality Managers • Quality Engineers • Small business owners • GxP • Consultants<\p>
https:\\www.compliancetrainings.com\SiteEngine\ProductDetailView.aspx?id=FDB1054 <\p>
Speaker Features Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport so as to Conformation other-direction". Ourselves has 30 years of test intrusive the Pizzazz sciences industry spanning The morrow Canniness, Quality Fervent hope and Regulatory Affairs and has a noticeable aimed at speeding up Software Compliance. Ms. Bazigos is the president with respect to PRCSQA (Tranquil Regional Page of the Society of Factor Positiveness) a runner about the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma \ Biotech \ Medical Device companies as effectually as finding groups wherewith compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and View Enactment doublet to investor groups and utility. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Fact-finding \ Current Data Gentry and Data Integrity Concepts by virtue of FDA, DIA and Academia. She is on the borough council for UC Berkeley's Proposition School in favor of Executive Tutelage in Party Sciences and on the Stanford Who's Who Registry for contributions to the Life science industry<\p>