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
President, JAMES HARRIS ASSOCIATES ,INC.
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 & AssociatesMark 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, LLCIntroductory Offers
Discount Price: $2999.00Actual Price: $7000.00
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