Online Webinar :Key Considerations for Cleanroom Design and Facility Validation
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Website http://c2gowebinars.com/product/?topic=cleanroom-design-facility-validation |
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Deadline: June 07, 2016 | Date: June 07, 2016
Venue/Country: Online, U.S.A
Updated: 2016-05-03 16:54:01 (GMT+9)
Call For Papers - CFP
DESCRIPTIONThis seminar is intended to discuss FDA regulations and the requirements for an effective cleanroom and facility validation as part of good manufacturing practices (CGMP) for sterile drug and biological products.When designing a cleanroom, many factors should be considered to adequately implement the requirements for an effective cleanroom design and validation. Otherwise, it can be costly and time-consuming later. In this seminar, the speaker will present what firms should know about the statutory and regulatory requirements so that the industry can implement good manufacturing practices to ensure an effective cleanroom design and validation. This seminar will greatly help you understand and establish an effective environmental monitoring program in view of CGMP (USP, ISO and FDA recommendations). The speaker will walk you through the FDA compliant practices.Areas To Be Covered in this Seminar:Laws and RegulationsDefinitionsCGMP Requirements for Pharmaceutical IndustryRegulations Governing Buildings and FacilitiesInternational Standards and Guidance Documents: ISO, USP, and FDAComparative Overview of Air and Cleanroom Classification: FDA, ISO and EU EMAWhat to Consider Designing a CleanroomCleanroom Validation: Principles and TestingDetermining What Tests to Perform During a Cleanroom ValidationKey Requirements for Personnel Training, Qualification and MonitoringImportant Laboratory ControlsImplementing an Effective Monitoring ProgramFDA Enforcement ActionsPASS-IT Suggestions (Best Practices)Who will benefit:Professionals in healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.Compliance OfficersRegulatory AffairsClinical AffairsQuality AssuranceLaboratory PersonnelIT ProfessionalsR&DConsultantsWebinar includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides60 Minutes Live PresentationCertificate of attendanceFor Registration : http://c2gowebinars.com/product/?topic=cleanroom-design-facility-validationNote: Use coupon code and get 15% off on registration.
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