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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