Regulatory & Compliance
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Cleaning Validation – Health Based Limits and Beyond: Answers to Current Industry GapsThomas WoodyOn-demand00
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Document Authoring, Archive, and Inspection – Challenges And Tips For Establishing Audit-Proof ProcessesDaniel Orfe, Betsy FallenOn-demand00
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Understanding The New NIH/HHS Final Rule On Clinical Trial Reporting – Tips For Compliance SuccessMichael PierroOn-demand00
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Computer Systems Validation (CSV) – Avoiding The Top Five Regulatory PitfallsAlecia AdamsOn-Demand00
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Understanding and Implementing the EU Regulation for Initiating and Conducting Clinical TrialsMichael PierroOn-Demand00
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Bioprocess Facility Design – Layout Rules and ConfigurationsErich Bozenhardt, Herman BozenhardtOn-Demand00
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Simplifying Your Quality System While Implementing ISO 13485:2016 Requirements – Strategies for SuccessMarcelo TrevinoOn-Demand00
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EU vs. US GMP: Understanding Major Differences Post FDA/EMA Mutual Recognition AgreementJoanna GallantOn-Demand00
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Medical Applications in 3-D Printing: Clinical Benefits, Regulatory Issues, and Manufacturing ChallengesMichael DruesOn-demand00
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Laboratory Data Integrity: Current Expectations for OOS Result InvestigationsJoanna GallantOn-Demand20