GxP A Basic Guide to IQ, OQ, PQ in FDA-Regulated Industries FDA Warning Letters FDA Continues to Cite OTC Drugmakers for CGMP Violations FDA Compliance A Guide to FDA's New Inspection Protocol Project (NIPP) for Sterile Manufacturing Sites In the News FDA’s Crackdown on OTC Manufacturers: A Guide to CGMP Compliance Medical Devices FDA Medical Device Inspections in 2019: Inside 2 Recent Draft Guidances Pharmaceuticals A Guide to FDA's 'Risk-Based' Site Selection Model for CGMP Surveillance Inspections Good Manufacturing Processes FDA Increases 'Risk-Based' Drug Manufacturing Inspections & Strengthens Genotoxic Impurity Testing Staff Resourcing 5 Steps to Creating an Effective Life Science Validation Team Medical Devices Inside FDA's Final Guidance on Device Manufacturing Site Changes Process 8 Problems That Can Lead to Medical Device Complaint Backlogs Medical Devices CAPA Compliance: 4 Problems That Can Threaten Your Process Process An Informed Guide to Human Error in CAPA Quality Systems Medical Device Document Control: 4 Common Issues to Avoid Medical Devices What The FDA Expects From Your CAPA Process Medical Devices FDA to Add Cybersecurity to RTA Checklists & Other Criteria For Premarket Review 503B FDA Announces Increased Risk-Based Oversight for 503A & 503B Compounding Facilities Medical Devices The Problem with 8D for CAPA Under FDA and ISO Regulations Data Integrity Data Integrity Remediation: A Quick-Guide to Investigating & Resolving Root Cause FDA regulatory consultants 4 Ways Regulatory Compliance & QA Consultants Offer Unique Value & Cost-Effectiveness CAPA How to Determine When CAPA is Appropriate In the News EUDAMED Nomenclature Requirements: Inside the First EU MDR and IVDR Guidance FDA Warning Letters 5 Key Questions to Ask After Receiving an FDA Warning Letter Medical Devices EU MDR Compliance & Transition: A Strategy for Implementation Medical Devices The First Step in Transitioning to EU-MDR Compliance Medical Devices A Quick Guide to Clinical Evaluation Under EU-MDR In the News FDA Final Rule: Foreign Medical Device Trials Must Conform to GCP In the News New Report Analyzes Recent Spike in CDER Warning Letters Conducting Data Integrity Audits: A Quick Guide Medical Devices MDR vs. MDD: 13 Key Changes Medical Devices Is Medical Device Risk Analysis Required by the FDA? Medical Devices [Free Webinar] The Complete Guide to EU-MDR Transition FDA Inspections Foreign FDA Inspections: A Guide to FDA's Pre-Inspection Procedures Compounding Pharmacies Preparing for FDA's Proposed CGMP Regulations for Compounding Pharmacies In the News FDA Warning Letter & Enforcement Trends of 2017: A Year in Review Quality Systems Compounding Pharmacies and CGMP: A Primer ANDA Preventing FDA Refuse-to-File Decisions for NDAs, ANDAs, and BLAs: A Quick Guide Quality Systems Assessing the Applicability and Necessity of CGMP to Drug Compounding Good Manufacturing Processes [Webinar Snippet] Key QMS Components for Compounding Pharmacy CGMP Compliance Data Integrity 4 Ways Data Integrity is Being Improved in Clinical Research In the News 5 Items on FDA's 2018 Regulatory Agenda Quality Systems Quality System Centralization vs. Decentralization: The Pros & Cons In the News FDA Makes Changes to Priority ANDA Draft Guidance Risk Management 3 Key Areas to Assess When Integrating an Incoming Quality System 503B [Free Webinar] The Importance of CGMP to the Safety of Compounded Drugs In the News FDA Will Recognize GMP Inspections from 8 EU Countries Medical Devices [Free White Paper] Harmonizing Disparate Quality Systems Medical Devices 3 Clarifications Made in FDA's 510(k) Submission Final Guidances In the News HHS Office of Human Research Protection Delays Implementation Deadline for Changes in Common Rule 503B 503A vs. 503B: A Quick-Guide to Compounding Pharmacy Designations & Regulations Medical Devices Canada Still On-Track for 2019 MDSAP Deadline Medical Devices Combination Product Compliance: 5 Key Factors to Consider Medical Devices [Free Recorded Webinar] Harmonizing Disparate Quality Systems News For the First Time, The FDA Group Appears on Vault’s 2018 Rankings for Best Consulting Firms for Work/Life Balance News For the Third Time in a Row, The FDA Group Appears on Inc. 5000 List of America’s Fastest-Growing Private Companies News Medical Device Submission & Filing Fees Are About to Rise Significantly FDA Warning Letters FDA Warning Letters in 2017: A Mid-Year Trend Report Process A Basic Guide to Writing Effective Standard Operating Procedures (SOPs) GxP 4 Ways ICH E6 (R2) 2016 Impacts Good Clinical Practice (GCP) Data Integrity Audit Trail Requirements in Electronic GxP Systems: A Quick Guide Medical Devices Ensuring MDSAP Readiness Through a Preparatory Audit Medical Devices A Quick Guide to MDSAP's New Nonconformity Grading System News The FDA Group's Brie Stoianoff & Husband Kevin Byrne Discuss Their Mission to End MS on Portland Today Medical Devices 3 Ways to Prepare for the MDSAP Internally Medical Devices [Free Webinar] Preparing for the Medical Device Single Audit Program In the News The FDA Group's Larry Stevens to Baltimore Sun: The Regulatory Path to Warning Labels for Acid Reflux Drugs Quality Standards CSV & Remediation: 6 Components of a Successful Program FDA Form 483 Using Quality Risk Management to Cultivate a Culture of Quality Cybersecurity GxP Electronic Record Metadata: Mitigating Regulatory Risks FDA Form 483 5 Steps to Ensuring CAPA Compliance Quality Standards An Ethical Framework for Enterprise-Wide Data Integrity FDA Compliance 6 Ways to Ensure Data Integrity in FDA-Regulated Industries FDA Auditing Audit Trail Checklist: 8 Questions to Ask When Configuring GMP QC Laboratory Audit Trails Data Integrity [Free Recorded Webinar] Ensuring Enterprise-Wide Data Integrity in FDA-Regulated Industries Medical Devices The Anatomy of an MDSAP Audit FDA Warning Letters FDA Warning Letters in Early 2017 Highlight Need for GMP Audits at Foreign Sites Process GMP vs. GLP in Laboratory Testing & Validation Medical Devices ISO 13485:2016 & MDSAP: How to Prepare Your QMS Now Process 6 Ingredients of an Effective Internal Audit Program Process The Data Integrity Triad: A Framework for FDA-Regulated Manufacturers News 6 Key Medical Device Provisions in the 21st Century Cures Act News FDA Issues Final Guidance Covering CGMP Requirements for Combination Products FDA Warning Letters Inadequate CAPA Tops List of Compliance Problems for Medical Device Companies in 2016 In the News 3 Important Changes in FDA's Final Guidance for Postmarket Medical Device Cybersecurity Process How the 21st Century Cures Act Will Accelerate Medical Device Approvals Process A 5-Step Guide to Qualifying FDA-Regulated Suppliers Process A Risk-Based Approach to Managing Supplier Quality Process A Quick Guide to FDA's Expectations for Supplier Quality Process FDA Guidance Clarifies Quality Agreement Expectations for Drugmakers News NH-ISAC, MDISS & FDA Announce New Medical Device Cybersecurity Initiatives FDA Compliance Qualifying Suppliers & Managing Quality in FDA-Regulated Industries [Webinar] FDA Warning Letters How to Prepare for an FDA Inspection: 6 Quick Tips Process Does My Modified Medical Device Require a New 510(k)? Process Risk Management & Medical Devices: 4 Common Problems to Avoid In the News Medical Device Cybersecurity: New FDA Recommendations for Manufacturers FDA Programs Longer Orphan Drug Review Times: Advice for Manufacturers News Press Release: The FDA Group Appears on Inc. 500 List of America’s Fastest-Growing Private Companies for the Second Year in a Row In the News Press Release: The FDA Group Hires Industry Expert Brie Stoianoff as Director of Quality & Service Assurance News Adopting FDA’s Benefit-Risk Approach to Medical Device Compliance & Enforcement Decisions Medical Devices 6 Supplier Quality Mistakes FDA-Regulated Companies Should Avoid FDA Warning Letters 6 Reasons to Get Expert Help When Handling Warning Letters & FDA 483 Process A 5-Step Guide to FDA Warning Letter Recovery Process 5 Tips for Writing an Effective FDA 483 Response News CEO One on One with The FDA Group President, Nick Capman FDA Warning Letters 9 Top FDA 483 and Warning Letter Problems for Device Companies in 2015 News Press Release: The FDA Group Ranks #3 on Boston Business Journal's "FAST50" 2016 Process 8 Key Points from The FDA’s Draft Guidance on Data Integrity and CGMP Compliance News The FDA’s Final Quality Metrics Guidance: 3 Smart Ways to Prepare Now FDA Warning Letters 3 Key Elements of a Successful CAPA System FDA Warning Letters 3 FDA Warning Letter Trends for 2016 Process The Quick Guide to FDA Part 11 Compliance Process 5 Ways to Identify the Root Causes of Regulatory Compliance Issues FDA Warning Letters 5 Common Mistakes to Avoid in Your FDA 483 Response 510K PROCESS 6 Mistakes to Avoid When Submitting a 510(k) to the FDA FDA Presents Guidance Agenda for 2016 How to Prepare Class II Devices for Compliance with The FDA’s UDI Mandate Regulations 5 Items to Stock in Your FDA Inspection War Room FDA Warning Letters 5 Indirect Costs of an FDA Warning Letter Process 4 Things the FDA Looks for in Quality Metrics Process Meaningful Use Program Suspended: What You Need to Know Process Why Medical Device Manufacturers Should Focus on Post-Market Data in 2016 In the News 3 Things to Expect from the CDRH in 2016 and 2017 FDA Programs How a New FDA Program Helps Pharmaceuticals Implement Emerging Technology FDA Warning Letters 10 Key Elements of an FDA 483 Response Regulations FDA Group’s Larry Stevens Finds Major Issues With Sen. Cruz’s FDA Overhaul Proposal FDA Inspections What Happens During an FDA Inspection? FDA Warning Letters The 3 Ingredients of an FDA-Compliant Tweet Process 3 Parts of a Comprehensive GCP Quality Audit Process How to Choose the Right Expedited FDA Approval Program Process The FDA Finalizes Proposal to Implement Regulations on Lab-Developed Tests Compliance Consulting The FDA Group President Nick Capman Interviewed at Vistage Executive Summit 2015 Process Laboratory Developed Tests: Issues and Anticipated Regulations Process The Latest on the Generic Drug User Fee Amendment Process FDA Postapproval Issues: An Overview Process New FDA Proposal for Quality Metrics Process The FDA's Biosimilar Naming Guidelines Process The FDA and Nanotechnology Process Personalized Medicine and the FDA Process How to Handle Reporting of Adverse Events Process 5 Steps in Developing Remediation Projects Process What Is a De Novo Classification? 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