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    Healthcare Regulatory Proficiency ForumHealthcare Regulatory Proficiency Forum
      • Home
      • Webinars
      • Past Webinars
      • Courses  
        • Seminars
        • Recorded Seminars
        • Recorded Webinars
      • About
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      • Blog
      1. Home
      2. Courses
      3. Recorded Seminars

      Recorded Seminars

       

      Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities

       

      FDA Inspections and Audit Readiness Course

       

      GLP Laboratory Compliance Documentation and Recordkeeping

       

      Internal and External / Supplier Audits Essentials

       

      Performance of Root Cause Analysis, CAPA, and Effectiveness Checks

       

      Validating and Auditing Cloud, SaaS, IaaS, PaaS Systems - Tech & Validation Trends for FDA Compliance

       

      FDA Inspections - Top FDA 483 Observations and Prevention Strategies

       

      Technical Writing Excellence in the Life Sciences - A Masterclass

       

      The DHF, Technical Documentation - Similarities, Differences and the Future

       

      Project Management in the Life Sciences - Project Management Fundamentals for Non-Project Managers

       

      Bottlenecks to Flow: Optimizing Design Controls and Validation in Medical Device QMS

       

      SaMD Masterclass - Validation, Change Management, Cybertechnology, and Best Practices

       

      Developing Effective Post Market Surveillance and Complaint Handling Requirements (Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls)

       

      Human Error Prevention Training - Preventing Active and Latent Error in the Life Sciences

       

      Supplier And Contract Manufacturer Management

       

      Verification and Validation - Product, Equipment / Process, Software and QMS

       

      FDA Inspections Seminar for 2024

       

      Analytical Instrument Qualification and Excel Validation - Preparing for FDA Audits

       

      CSV vs CSA - Waterfall vs. Agile Methodology, Documentation and Implementation

       

      Design of Experiments 101 - Methods and Analysis

       

      FDA Inspections - Top FDA 483 Observations and Prevention Strategies

       

      Technical Writing Excellence in the Life Sciences - A Masterclass

       

      The FDA QMSR and the Key Elements of QSIT cGMP Inspection and Audits for Medical Device Manufacturers

       

      3-Hour Virtual Seminar on Digital Validation Demystified - GAMP® 5 2.0 and CSA Integration

       

      Good Manufacturing Practices (GMP) 101

       

      Data Integrity – In compliance with CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR

       

      Writing SOP’s and Work Instructions that Really Work

       

      OOS and OOT Investigations Course - Best Practices, Key Components and FDA Requirements

       

      Supplier And Contract Manufacturer Management

       

      Project Management in the Life Sciences - Project Management Fundamentals for Non-Project Managers

       

      FDA Inspections - Top FDA 483 Observations and Prevention Strategies

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