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Online Webinar
22 Mar 2016
Internal Market

Best practices for effective Cleaning Validation - By AtoZ Compliance.

Understand the compliance perspectives on Cleaning Validation and areas of concern during regulatory inspections, enabling you to set up Cleaning Validation procedures and reports that meet current FDA, WHO, PIC/S and EU regulations.

Speaker: Joy McElroyKey Take AwayUnderstand the compliance perspectives on Cleaning Validation and areas of concern during regulatory inspections, enabling you to set up Cleaning Validation procedures and reports that meet current FDA, WHO, PIC/S and EU regulations.OverviewThis webinar provides practical guidance on cleaning validation guidelines for regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This webinar will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a “Cleaning Validation Master Plan” and the appropriate documentation for each study to be performed. Why Should You AttendThis webinar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this webinar particularly useful.  This includes Analytical Method Development, Quality Control, and Quality Assurance personnel.Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this webinar. Areas Covered In This WebinarFDA Requirements and Industry Standard PracticesHow to Develop/Review your Cleaning Procedures and the Adequate Selection of Cleaning Agents and ParametersHow to Develop a Cleaning Validation Policy/ProgramHow to Implement a Robust Cleaning Validation PlanLaboratory Issues in CleaningMicrobiological aspects of a Cleaning Validation Program for Manufacturing EquipmentKeys to Cleaning Validation Maintenance – Remaining CompliantCurrent FDA concerns about Validation of Cleaning Processes Learning ObjectivesUnderstand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections due to regulatory compliance requirements Who Will BenefitSenior Quality ManagersQuality ProfessionalsProduction SupervisorsValidation EngineersProcess OwnersQuality EngineersQuality AuditorsLevelBeginner

When

22 Mar 2016 @ 01:00 pm

22 Mar 2016 @ 02:30 pm

Duration: 1 hours, 30 minutes

Timezone: GMT -5:00


Where

Online Webinar


Language

English en


Organised by

AtoZ Compliance (deactivated)

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