DR. DAVID LIM

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

MD2002

DR. DAVID LIM

Duration: 60 Minutes

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

FDA Inspection and Medical Device Design Control

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

Implementing Best Practices for Global Regulatory Intelligence Programs

Opioid and Pain Management: FDA Perspectives and Requirements

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

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

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

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

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

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

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

FDA Off-Label Promotion Guidelines webinar

FDA Generic Drug Application and Paragraph IV webinar

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

Complaint Handling – Best Practices webinar

FDA’s New Inspection Policy and Best GMP Practices

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

FDB2516

DR. DAVID LIM

Duration: 60 Minutes

Complaint Handling & Medical Device Reporting (MDR)

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

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

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

FDA Inspection and Medical Device Design Control

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

Implementing Best Practices for Global Regulatory Intelligence Programs

Opioid and Pain Management: FDA Perspectives and Requirements

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

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

ANDA Approval Process Pursuant to GDUFA

FDA Good Laboratory Practices (GLP) Regulations

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

Establishing a Product Stability Testing Program

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

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

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

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

Establishing FDA-Compliant Social Media Practices to Avoid FDA Actions

Validation and Use of Excel Spreadsheets in FDA Regulated Environments webinar

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

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

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

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

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

FDA Off-Label Promotion Guidelines webinar

FDA Generic Drug Application and Paragraph IV webinar

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

Complaint Handling – Best Practices webinar

FDA’s New Inspection Policy and Best GMP Practices

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