Compliance Trainings, Canada
2015-03-19
Description : Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Areas Covered in the Session : Regulatory requirements for spreadsheets; FDA Part 11 and GxP Recent FDA inspectional observations and warning letters Recommendations from the new GAMP®5 and EU Annex 11 How to design spreadsheets for compliance. How to design, ensure and validate spreadsheet integrity. When, what and how much to test? Validation of standard/native Excel functions? How to apply risk based validation to spreadsheet applications Validation of 'ad hoc' spreadsheet applications. How to document planning, specifications, installation, testing and changes Examples from manufacturing, laboratories and offices Who Will Benefit: Everybody developing and using Excel Worksheets for regulated environments Developers and users of spreadsheet templates Lab Supervisors and managers QA managers and personnel QC managers and personnel IT managers and personnel Analysts and lab managers Validation groups Training departments Documentation department Consultants Teachers Price tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 For more information and enquiries contact us at Compliance Trainings 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com Like Us On Facebook: https://www.facebook.com/events/1420672971563933/?source=1&sid_create=2316851725
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