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      1. Home
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      4. Pharmaceuticals

      Pharmaceuticals


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      ChatGPT and AI-Powered Project Management - Revolutionize your Projects Now

      PM3369
      CHARLES H. PAUL

      Duration: 60 Minutes

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      Recording
        

      Corrective Actions Preventive Actions - CAPA 101

      FDB3598
      Alan M. Golden

      Duration: 60 Minutes

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      Recording
        

      Sampling Plans for Verification, Validation and Production

      FDB2287
      JOSÉ MORA

      Duration: 90 Minutes

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      Recording
        

      The Transfer Of Validated Methods

      FDB3467
      Dr. JOHN C. FETZER

      Duration: 60 Minutes

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      Recording
        

      Analytical Method Validation under Good Laboratory Practices (GLPs)

      FDB3460
      Dr. JOHN C. FETZER

      Duration: 90 Minutes

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      Recording
        

      eCTD Submissions - Fundamentals and Process

      FDB3662
      CHARLES H. PAUL

      Duration: 90 Minutes

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      Recording
        

      How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

      FDB3690
      KELLY THOMAS

      Duration: 90 Minutes

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      Recording
        

      Calculations for Process and Product Capability

      FDB3132
      ELAINE EISENBEISZ

      Duration: 90 Minutes

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      Recording
        

      Nitrosamines Impurities Management

      FDB3534
      G. SUNDAR

      Duration: 2 Hour

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      Recording
        

      Statistical Methods For Process Validation

      FDB3597
      Alan M. Golden

      Duration: 60 Minutes

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      Recording
        

      Business Continuity Planning For Contract Manufacturers In The Life Sciences

      FDB3667
      CHARLES H. PAUL

      Duration: 90 Minutes

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      Recording
        

      Compliance Audit Enhancement Using Principles Of Lean Documents And Lean Configuration

      FDB2285
      José Mora

      Duration: 90 Minutes

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      Recording
        

      HPLC Analytical Method Development And Validation

      FDB2324
      Dr. JOHN C. FETZER

      Duration: 60 Minutes

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      Recording
        

      Risk Assessment Demystified And Digital Advancements

      FDB3514
      Saurabh Joshi

      Duration: 60 Minutes

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      Recording
        

      Latest Regulations For Quality Metrics And KPIS

      FDB3615
      MEREDITH CRABTREE

      Duration: 90 Minutes

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      Recording
        

      OOS And Setting Specifications For Pharma, Biopharma And Combination Products

      FDB3416
      KELLY THOMAS

      Duration: 90 Minutes

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      Recording
        

      Practical Implementation Of Pharmaceutical Quality Risk Management (QRM)

      FDB2302
      STEVEN LAURENZ

      Duration: 60 Minutes

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      Recording
        

      GCP Risk Management And Risk-Based Monitoring

      FDB3664
      CHARLES H. PAUL

      Duration: 90 Minutes

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      Recording
        

      Setting Up Scientifically Sound Laboratory Controls - Specifications And Test Procedures

      FDB3532
      G. SUNDAR

      Duration: 90 Minutes

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      Recording
        

      Project Management For Non-Project Managers Series - Project Management As Applied To Clinical Trials

      PM356114
      CHARLES H. PAUL

      Duration: 90 Minutes

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      Recording
        

      Project Management For Non-Project Managers Series - Project Management Process In Development Of In Vitro Diagnostics

      PM356113
      CHARLES H. PAUL

      Duration: 90 Minutes

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      Recording
        

      Project Management for Non-Project Managers - Project Management in Drug Development

      PM356111
      CHARLES H. PAUL

      Duration: 90 Minutes

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      Recording
        

      Sampling Plans For Verification And Validation, Production Process Validation And Production Control

      MD1887
      JOSÉ MORA

      Duration: 90 Minutes

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      Recording
        

      Process Verification And Validation - Principles And Protocols

      MD1983
      JOHN E. LINCOLN

      Duration: 90 Minutes

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      Recording
        

      Project Management For Non-Project Managers - Getting The Project Off The Ground - Preliminary Project Planning

      PM356902
      CHARLES H. PAUL

      Duration: 2 Hour

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      Recording
        

      Hypothesis Testing, P-Values, And Inference – When Thinking Like a Statistician Makes Sense

      ST3138
      ELAINE EISENBEISZ

      Duration: 90 Minutes

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      Recording
        

      3-Hour Virtual Seminar On Batch Record Review And Product Release

      FDB3282
      DANIELLE DELUCY

      Duration: 3 Hour

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      Recording
        

      Continued Process Verification And Process Monitoring

      FDB3098
      KELLY THOMAS

      Duration: 90 Minutes

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      Recording
        

      Step-By-Step Process For Successful Sterility Failure Investigations

      FDB2465
      DANIELLE DELUCY

      Duration: 75 Minutes

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      Recording
        

      Human Error Investigation Program - Effective Implementation

      FDB3074
      Dr. Ginette Collazo

      Duration: 90 Minutes

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      Recording
        

      Photostability ICH Q1B: Practical Interpretation and Execution

      FDB2176
      SCOTT R. THATCHER

      Duration: 60 Minutes

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      Recording
        

      RISK MANAGEMENT AND IMPACT ASSESSMENTS IN CHANGE CONTROL

      FDB3592
      Alan M. Golden

      Duration: 60 Minutes

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      Recording
        

      DESIGN CONTROL 2023: PROJECT MANAGEMENT UTILIZING PRINCIPLES OF LEAN DOCUMENTS AND LEAN CONFIGURATION

      MD3358
      José Mora

      Duration: 90 Minutes

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      Recording
        

      ESTABLISHING AND REGAINING CONTROL OF CLEANROOM

      FDB3055
      JOY MCELROY

      Duration: 90 Minutes

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      Recording
        

      Good Documentation Practices

      FDB2866
      DANIELLE DELUCY

      Duration: 75 Minutes

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      Recording
        

      Impact Assessments for Supplier Change Notices

      FDB3591
      Alan M. Golden

      Duration: 60 Minutes

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      Recording
        

      FDA EXPECTATIONS FOR 505(B)(2) REGULATORY PATHWAY FOR NEW DRUGS

      FDB3208
      KELLY THOMAS

      Duration: 90 Minutes

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      Recording
        

      QUALIFICATION AND CONTROL OF CONTRACT MANUFACTURER ORGANIZATIONS BASED ON PRACTICAL EXPERIENCE

      MD3393
      Edwin Waldbusser

      Duration: 60 Minutes

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      Recording
        

      NAVIGATING THE FDA'S GUIDELINES ON OFF-LABEL PROMOTIONS

      FDB3209
      KELLY THOMAS

      Duration: 90 Minutes

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      Recording
        

      CHANGE CONTROL ACCORDING TO GXP AND GMP REQUIREMENTS

      FDB3082
      KELLY THOMAS

      Duration: 4 Hour

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      Recording
        

      Handling Out-of-Trend Results in Pharmaceutical Quality Control as per Latest FDA Requirements

      FDB3207
      KELLY THOMAS

      Duration: 90 Minutes

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      Recording
        

      FDA Case Scenarios – Best Practices for Managing Inspection Situations

      FDB2169
      DANIELLE DELUCY

      Duration: 75 Minutes

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      Recording
        

      POWER ANALYSIS FOR SAMPLE SIZE CALCULATIONS

      FDB3130
      ELAINE EISENBEISZ

      Duration: 90 Minutes

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      Recording
        

      IMPLEMENTING AN EFFECTIVE GLP COMPLIANT QUALITY MANAGEMENT SYSTEM

      FDB3469
      Dr. JOHN C. FETZER

      Duration: 90 Minutes

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      Recording
        

      3 Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

      FDB2688
      CAROLYN TROIANO

      Duration: 3 Hour

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      Recording
        

      3-Hour Virtual Seminar on Technical Writing for the Regulated Industries

      FDB2683
      JOY MCELROY

      Duration: 3 Hours

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      Recording
        

      Statistical Process Control (SPC) and Control Charts for Laboratory Compliance

      FDB3466
      Dr. JOHN C. FETZER

      Duration: 60 Minutes

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      Recording
        

      Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations

      FDB3142
      CAROLYN TROIANO

      Duration: 90 Minutes

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