FDA Regulations and Best Practices Course









FDA Inspection and Audit Process

  • FDA Inspection Preparedness
  • FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
  • Introduction to the FDA and Your First FDA Meeting
  • Current Trends in FDA Inspections
  • US FDA's Pre-Approval Inspection Program
  • How to Most Effectively Prepare for and Manage FDA Inspection: Best Practices
  • Preparing for and Managing FDA Inspections
  • Win-Win FDA Inspections
  • Preparing for an FDA Pre-Approval Inspection
  • How to Avoid 483's/ Warning Letters. What to Do If You Happen to Get One?
  • How to Respond to a FDA Inspection and Warning Letter
  • Project Risk Management

FDA Warning Letters

  • How to Avoid an FDA Warning Letter with a Strong CAPA Program
  • How to Perform Effective Supplier Audits, and Avoid FDA 483's and Warning Letters
  • The Most Serious FDA 483s - How to Avoid Them
  • FDA Warning Letter Closeout Program

Complaints & Recalls

  • Complaint Handling Requirements (US)
  • Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements
  • Conducting Successful Product Complaint Investigations
  • Complaint Handling in Compliance with FDA and ISO Regulations
  • Customer Complaint Handling - Meeting the Customer and Agency Needs

Documentation /SOP

  • How to Write SOPs: Tips on Writing the Perfect Document to Impress the FDA
  • Writing Effective and compliant SOPs
  • Writing Effective SOPs for Regulatory Compliance
  • Best Practices for Documentation for FDA Compliance
  • Effective Records, Document Control, and SOPs
  • Documentation - Develop & Implement an Efficient and Compliant System
  • Good Documentation Practices for GXPs
  • The 11 Must-have Documents of Software Verification and Validation

Marketing and Promotional Activities

  • Using Social Media in a FDA Compliant Manner
  • Social Media and Marketing FDA Regulated Products
  • Advertising and Promoting FDA Regulated Products - Is your House in Order?
  • Off Label Product Use Discussions in Social Media
  • Social Media: Using The Legal Guideposts to Create Social Media Success (for Healthcare/Lifescience Companies)
  • Fraud & Abuse in healthcare sales and marketing - Update on the Law and Tips on Compliance
  • FDA's Ambitious Regulation of Social Media

FDA Enforcement

  • Changes in US FDA Enforcement
  • FDA Regulatory Actions: It's Not Just about Warning Letters
  • How to Survive FDA's New Inspection and Enforcement Practices

FDA Compliance Training

    • Effective Training Practices for FDA Compliance
    • Educating and Training Staff to Manage Regulatory Records

21 CFR Part 11 Compliance

  • Importing Electronic Records & Electronic Signatures; 21 CFR Part 11
  • Using Electronic and Digital Signatures in Regulated Environments
  • The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications
  • 21 CFR 11 Compliance for Excel Spreadsheet
  • 21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s
  • 10-step Risk based Computer System Validation for SaaS/Cloud/Local
  • Current Concepts and Challenges in Cloud Compliance
  • Validation and Use of Cloud Computing in FDA Regulated Environments

FDA Supply Chain Management

  • Performing effective supplier audits: a coming FDA compliance focus'
  • Understanding the Current FDA Requirements for Raw Materials and Components
  • GMP Raw Materials Program Risk Management
  • Internal Audits and Supplier/Subcontractor Audits
  • How do I keep FDA happy with my contract manufacturer?
  • How do I Keep FDA Happy with my Contract Manufacturer
  • FDA's New Supply Chain Safety Initiative: Quality Control and Legal Ramifications for Drug, Device, and Biologic Manufacturers and Their Suppliers

Course Directors

Susan Muhr Leister

Director of Quality Assurance , Technical Resources International Inc.

Kenneth Christie

Chief Operating Officer, VTS Consultants Inc

Andrew Verderame

President, PharmaLex US, LLC

Michael Ferrante

President of Quality and Compliance Associates LLC

Sandra N. Whetstone

co-founder and Managing Director of Comprehensive Compliance Solutions, LLC

David Lim

Senior Vice President, Aquavit Pharmaceuticals

Jonathan M Lewis

Founder, Reliant FDA Experts (Reliant) (ABC), LLC

James R. Harris


Martha M. Bennett

Senior Compliance Officer, Bennett and Company

Angela Bazigos

CEO, Touchstone Technologies Silicon Valley Inc

Charles R. McConachie

Attorney, McConachie Law

John E Lincoln

Principal, J E Lincoln and Associates

Dennis Moore

President , AUK Technical Services LTD (ATS)

Alfonso Fuller

Founder and President , Fuller Compliance, LLC.

Vanessa Lopez

Sr Quality Regulatory Consultant, Quality and Regulatory Consulting Services

Jeff Kasoff

Director of Quality, Medivators

David Dills

Industry Regulatory & Compliance Consultant, Individual Consultant

Peter Calcott

President, Calcott Consulting

Mukesh Kumar

Regulatory Affairs and Quality Assurance, Amarex

Henry Urbach

Principal, GMP TDC LLC

Nick Campbell

Founder, Sunriver Risk Management

Anne E Maczulak

Principal Consultant, Acorn GLP Consulting

Mark DuVal

President, DuVal & Associates

Mark Gardner

Associate Attorney, DuVal & Associates

Kenneth N Rashbaum

Attorney, Rashbaum Associates LLC

Casper Uldriks

Former Associate Center Director, CDRH

Edwin L Bills

Principal Consultant , Bilanx Consulting LLC

Fredric Richman

Consultant, Compliance Achievers, LLC

Ludwig Huber

Director and Chief Editor, Labcompliance

Charlie Sodano

Founder, eOrganizedWorld

Harry Huss

Chief Compliance Officer, Touchstone Technologies Silicon Valley Inc

David Nettleton

FDA Compliance Specialist, ComputerSystemValidation

Jamie Jamshidi

Quality and Regulatory Advisor, Karyopharm Therapeutics Inc

Paula Shadle

Principal Consultant, Shadle Consulting

Amy E Fortenberry

Director of Regulatory Affairs, DMF Management Systems, LLC

Introductory Offers

Discount Price: $2999.00
Actual Price: $7000.00
Buy Now

(1 Year Access)