Seminars - Healthcare Regulatory Proficiency Forum

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

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

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

Project Management for Non-Project Managers - Certification Training Series

CHARLES H. PAUL

Good Manufacturing Practices (GMP) 101

FDA Inspections and Audit Readiness Course

GLP Laboratory Compliance Documentation and Recordkeeping

Production & Process Validation (Merging 820.75 with ISO 13485, and EU Annex 15)

CSV/CSA Masterclass for Modern GxP Systems - Defensible Validation Decisions Using Risk-Based Thinking

Design of Experiments 101 - Methods and Analysis

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

GMP Master Class for Life Sciences - Modular Course for Practitioners: Practical FDA-Compliant Good Manufacturing Practices Aligned to 21 CFR Parts 210, 211 & 820

FDA Inspections - Top FDA 483 Observations and Prevention Strategies

Technical Writing Excellence in the Life Sciences - A Masterclass

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

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

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

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

Supplier And Contract Manufacturer Management

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

FDA Inspections - Top FDA 483 Observations and Prevention Strategies

Technical Writing Excellence in the Life Sciences - A Masterclass