DR. DAVID LIM - Eventura

Complaint Handling & Medical Device Reporting (MDR)

Duration: 60 Minutes

The FDA 510(k) and Q-Submission: Best Practices

Duration: 60 Minutes

Demystifying Design Control: Design History File (DHF), Device History Record (DHR), and Device Master Record (DMR)

Duration: 60 Minutes

US FDA 510(k) – Latest Guidance, Due Diligence, Preparation, Submission and Clearance

Duration: 60 Minutes

FDA Inspection and Medical Device Design Control

Duration: 60 Minutes

FDA Inspection Preparation and Readiness – The Top 20 Most Common GMP Deficiencies

Duration: 60 Minutes

Implementing Best Practices for Global Regulatory Intelligence Programs

Duration: 60 Minutes

Opioid and Pain Management: FDA Perspectives and Requirements

Duration: 60 Minutes

FDA New Requirements for Pyrogen and Endotoxin Testing for Drugs, Biologics and Medical Devices

Duration: 60 Minutes

Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation

Duration: 60 Minutes

ANDA Approval Process Pursuant to GDUFA

Duration: 60 Minutes

FDA Good Laboratory Practices (GLP) Regulations

Duration: 60 Minutes

US FDA Drug Review and Approval Process – Understanding the Latest Regulations

Duration: 60 Minutes

Establishing a Product Stability Testing Program

Duration: 60 Minutes

GCP/GLP/GMP : Comparison and Understanding of FDA’s 3 Major Regulations

Duration: 60 Minutes

FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs

Duration: 60 Minutes

Pain Management and Opioids – FDA Regulations, Generics and Recent Approvals

Duration: 60 Minutes

Medical Device Laws and Regulations in Asia – China, India, Japan and Korea

Duration: 60 Minutes

Establishing FDA-Compliant Social Media Practices to Avoid FDA Actions

Duration: 60 Minutes

Validation and Use of Excel Spreadsheets in FDA Regulated Environments webinar

Duration: 60 Minutes

How to Best Document Clinical Evaluation Report (CER) for CE Mark webinar

Duration: 60 Minutes

What FDA-Regulated Industry Should Know about FDA’s New Policy on GMP Enforcement

Duration: 60 Minutes

Adequate 510(k) Preparation Could Save Significant Resources – Dos and Don’ts

Duration: 60 Minutes

510(k) Update – How to Format Succinct and Comprehensive 510(k)s – 3 Hours Virtual Seminar

Duration: 3 Hour

Medical Device Laws and Regulations in Asia – Part 2 – India, Japan, and Korea

Duration: 60 Minutes

Medical Device Laws and Regulations in Asia – Part 1 – China

Duration: 60 Minutes

FDA Off-Label Promotion Guidelines webinar

Duration: 60 Minutes

FDA Generic Drug Application and Paragraph IV webinar

Duration: 60 Minutes

FDA’s New Policy and Risk-Based Strategic Regulatory Updates for Critical Consideration

Duration: 60 Minutes

Complaint Handling – Best Practices webinar

Duration: 90 Minutes

FDA’s New Inspection Policy and Best GMP Practices

Duration: 60 Minutes