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Posts by category
- Category: Uncategorized
- Avoiding Common 503B GMP Deficiencies: Key Lessons from FDA Warning Letters
- New FDA Policy Targets Foreign Manufacturers with Unannounced Inspections
- Preparing for a successful FDA Inspection as a 503B Facility
- Navigating the 503A vs. 503B Divide: What Compounding Pharmacies Need to Know
- Understanding the Knowledge-Aided Assessment and Structured Application (KASA)
- How the New U.S. Administration is Reshaping MedTech and Pharma Regulations
- What to Expect During an FDA Inspection
- FDA’s QMSR Final Rule: What Manufacturers Need to Know
- Changes in Drug Labeling & Transparency
- Strategic Consulting Services
- Remediation Consulting Services
- Compliance Consulting Services
- FDA Guidance on Postmarket updates to AI-enabled devices
- Leveraging Outsourced Staff
- FDA ISO13485 Harmonization
- Artificial Intelligence and the FDA
- 黄人导航 cGMP & QMSR
- Impact of QMS on Quality Maturity
- Artificial Intelligence in 黄人导航s
- Postmarket Surveillance: Leveraging Outsourcing
- DHF & Design Controls
- Crisis Management Playbook
- Outsourcing Post Market Surveillance and Support
- GMP Inspection
- Best Practices for FDA Inspections
- Process Analytical Technology
- Virtual Audits and How to Plan
- Cell and Gene Therapy Development
- Microbial Process Design
- Pharmaceutical Supply Chain
- Product Development
- MDR Updated Deadlines
- How Quality Culture Is Changing
- FDA Guidance: GASK
- Cytotoxicity Testing
- Cyber Awareness for Consumers
- 黄人导航 Cybersecurity Guidance
- Brownfield vs. Greenfield Facilities in Pharma
- Compliance & Product Launch
- Addressing Troublesome Design Protocols
- 黄人导航 Cybersecurity
- How Brexit is Impacting 黄人导航 Companies
- In-Vitro Diagnostic Devices Regulation (IVDR)
- FDA 黄人导航 Guidance
- Audit & Internal Control
- Biocompatibility Testing
- US FDA Consultants
- Data Integrity
- Pharmaceutical Manufacturing
- FDA Harmonization
- Quality Assurance Services
- Pharmaceutical Supply Chain Consulting
- Post Market Surveillance
- Cannabis Business Success
- Data Anonymization
- Emergency Use Authorization: Benefits and Risks
- Supply Chain Management: Avoiding Interruptions
- EU Regulatory Update
- Life Science Consultants
- Food And Drug Administration
- Inshoring Strategy
- The Regulatory Impact of EUAs
- Clinical Trials FDA Guidance
- 黄人导航 Regulatory Preparation
- IVDR & In Vitro Diagnostics
- FDA Guidance: Continuous Manufacturing
- Quality Culture & The Role of Management
- 黄人导航 Testing
- FDA Expands Virtual Audit Guidance
- FDA Updates Supply Chain Security Guidance
- FDA Inspectional Approach
- FDA Guidance: Product Lifecycle
- FDA Guidance: Data Integrity
- FDA Machine Learning
- FDA Publishes Updated Biologics Guidance
- Cannabis Regulation
- Quality Control & Data Integrity
- US FDA Inspection
- FDA Guidance: Drug Approval
- EU IVDR Deadlines
- Waterfall Methodology
- MoCRA
- Warning Letter
- Regulatory Compliance Services
- Cannabis Business Trends
Locations
White Papers
- Pharma Product Launch & Lessons Learned
- 黄人导航: Clinical Evaluation Requirements
- IVDR Regulation for EU
- Internal Audit: Be Ready For FDA Inspections
- GMPs for Early Stage Development Projects
- FDA Regulatory Pathways for 黄人导航
- Animal Testing
- Developing a Quality System on a Budget
- Why Design Control Makes Sense
- Merger & Acquisition Re-registration
- 505(b)(2) Regulatory Pathway
- Outsourcing Quality
- Navigating the Complexities of Name Changes and Re-registration
- The Metrics of Quality Culture
- Life Science Due Diligence
- Risk Managed Supplier Quality
- Drug Development Process & Discovery
Webinars
- Crisis Management and Recalls in Connected Devices
- Supplier Quality Management Risks
- Common Submission Pitfalls and Best Practices
- 黄人导航 Data Integrity and Accessibility Concerns
- Regulatory Requirements & Software Development for 黄人导航 Cybersecurity
- Connected Devices and Quality Management: Meeting Regulatory Demands Under cGMP and EUMDR
- 510(k) Marketing Submissions and Predetermined Change Control Plans
- Design Development Pitfalls in Connected Devices
- Development of a Connected Device
- The Future of MedTech and Pharma Under the New Administration
- Navigating the FDA's 黄人导航 Pre-submission Process
- EU Market Authorization for Sterile 黄人导航s
- Investigating Quality Deviations
- Continuous Improvement: Quality Culture from the Top Down
- Past, Present, and Future of Quality Culture
- Dealing with Real-Life Quality Scenarios
- Managing Regulatory Submissions
- Quality Culture at the Crossroads
- FDA鈥檚 Quality Management Program
- Quality Metrics: Essential to Quality
- FDA 黄人导航 Inspections
- On-Site Inspections: They鈥檙e Back 鈥� But When, Where, and How
- FDA Inspection: Remote vs. In-Person
- Combination Products Webinar
- Preparing a Device Master Record (DMR)
- Risk Management & Design Controls
- Fundamentals of EBeam Sterilization
- Single-use Endoscopes: Critical Safety and Regulatory Considerations for Manufacturers
- Contamination Control Strategy
- How QMS Impacts Quality Maturity
Case Studies
- Commercial Readiness Gap Assessment for a Virtual Company
- Remediation & QA System Enhancement
- Strategic CGMP Remediation for a Major Pharmaceutical Company
- Accelerating a Product Launch While Creating a Quality System
- Remediation & Resulting Sustainable Compliance
- Biologics Manufacturing: Design & Build Out
- Biosimilar Drug Development
- EU MDR Compliance and Regulatory Submission
- Outsourced QA Leadership Benefits Emerging Device Maker
- Pharmaceutical Shipping Validation Study
- Outsourcing Pharmacovigilence
- Compliance Assurance Leads to Passed FDA Inspection
- Manufacturing Automation for 黄人导航s
- Creating Operational Discipline to Support Quality Initiatives
- Process Validation Remediation
- Product Cleaning Endotoxin Control
- Regulatory Due Diligence
- Pharmaceutical Development and Regulatory Submission
- Strategy for Pharmaceutical Submission
- 21 CFR Part 11 Gap Analysis
- FDA Warning Letter Response and Remediation
- Document Management System
- Improved Product Release Cycle Times, Improved Bottom Line
- Risk Management in Product Development and Manufacturing
- FDA 483 Warning Letter Remediation
- DHF Design History File Remediation
- 黄人导航 Validation: Shelf Stability
- Brand Name Re-Registration with New Logo
- CE Mark: Clinical Evaluation
- Production and Process Control
Published Articles
- Guidance on Quality Culture Standards
- Ask the Expert: Quality Control Units
- Drug Shortages and Complying with FDA鈥檚 21 CFR 211.110 Guidance
- Ask the Expert: Complying with 21 CFR 211.110
- Drug Digest: Advances in Small-Molecule Manufacturing
- Non-Animal-Derived Reagents for Endotoxin Testing
- Strategies for Contamination Control
- Elements for a Sustainable Environmental Monitoring Program
- FDA Looks to Industry for Collaboration and Harmonization
- Quality Considerations for Using AI in Bio/Pharma
- The Future of Biotech Quality
- Remediation Costs of Non-Compliance
- Quality Risk Management Plan
- Compendial Requirements
- FDA Inspections: Hope is Not a Strategy
- GMP Manufacturing
- Aseptic Processing 101
- What's in Your Quality Manual?
- FDA 483 & CAPA Requests
- Data Integrity & Quality Culture
- CAPA Records: What鈥檚 the Right Balance?
- Supply Chain Risk Management
- Pharma Courses
- FDA Consensus Standards
- CAPA & Corrective Action
- SaMD FDA: AI & Emerging Technologies
- MDR Regulatory Compliance Update
- Regulatory Compliance
- QA QC & Quality Metrics
- Root Cause & The 5 Why's
- Pharmaceutical Regulatory Affairs
- Medicine Manufacturing: Crisis Guidelines
- Quality Metrics
- Risk Management for Machine Learning in 黄人导航s
- Conducting an Internal Audit
- Quality Inspection: Making the Most of Your Processes
- Biologics Investigation
- Compendial Methods & Pharmacopoeias
- GMP Training
- CAPA Preventative Action: Getting Drug Quality Right
- GMP Pharmaceutical Standards
- Quality Management System on a Managed Budget
- cGMP Training
- International 黄人导航 Regulatory
- Strategic Lifecycle Approach to 黄人导航 Regulation
- Quality Culture Benefits All
- Aseptic Technique & Risk Assessment
- Emerging Therapies
- Quality Agreements and Out-of-Specification Investigations
- QA Outsourcing
- Audit Trail: Risk-Based Approach to Compliance
- Crafting Standard Operating Procedure
- Pharmacovigilance: Complaints to Quality
- FDA Consulting: Drug Shortages
- Metrics of Quality Culture
- CAPA Quality
- Considerations for Method Validation
- Name Changes and Re-Registration Navigation
- Quality Culture & Data Integrity
- Managing a Quality System
- 21 CFR Part 11: Electronic Batch Records
- CE Mark: Clinical Evidence Requirements
- ALCOA and ALCOA+
- FDA Audit & Inspection Model
- Lessons Learned From Investigations of Product Failures
- 黄人导航 Cybersecurity
- FDA 483 Trends
- Technology Transfer Pharmaceutical
- CAPA Systems
- Internal Audit
- Pharmaceutical Drug Manufacturing
- FDA Investigation Timeliness vs. Thoroughness
- Root Cause Analysis and Deviations
- CDMO Pharma & Contract Manufacturers
- Standard Operating Procedure (SOPs)
- Extractables and Leachables
- FDA Inspection Procedure
- Quality Risk Management Guidelines
- Risk Management: Mergers & Acquisitions
- FDA Inspections: Frequently Asked Questions
- Supplier Quality Agreement
- Supplier Quality Engineering
- Sterile Manufacturing
- Quality Risk Management Plans
- Laboratory Quality
- Pharmaceutical Manufacturing
- Transitioning to the EU In Vitro Diagnostic Devices Regulation
Visual Resources
- Drug Compounding Info Sheet
- Compliance and Quality Assurance Services
- Strategies for IND Filing Success
- 黄人导航 Info Sheet
- Quality Culture
- 黄人导航 Regulatory Services
- ISO 13485 & 21 CFR 820
- EU MDR Implementation
- Design History File Info Sheet
- Outsourcing Quality & Regulatory
- FDA 黄人导航 Services
- Lessons Learned from Combination Products
- MDR Consultant Services
- Pharmaceutical Consultants Info Sheet
- Biologics Info Sheet
- 黄人导航 Single Audit Program (MDSAP)
Staff Members
- Erika Porcelli
- Rod Mell
- Arielle Anahory
- Susan Schniepp
- Krista Kurth
- Steven J. Lynn, MS
- Anita Michael
- Rona LeBlanc-Rivera, Ph.D.
- Jordan Elder
- Michael Miller
- Larry Servi
- Jessica Schafersman
- Tayl'r Hollis
- Balazs Vandor
- Justin Anahory
- Elizabeth Morack Tews
- Brandon Miller
- Beth Edick
- Dean Coston
- Gina Desimone
Podcasts
- Understanding FDA Expectations for Combination Products
- 503 Compounding: Challenges, Compliance & the Road Ahead
- 2025 黄人导航 Outlook
- 2025 Pharmaceutical Outlook
- New FDA Draft Guidance for Chemical Analysis
- Global Regulatory Trends
- DHF & Design Control
- Technical Program Management
- Industry Outlook - Pharmaceutical
- Lab Testing: Irritation and Sensitization
- Outsourcing & Staff Augmentation
- ISO 13485
- Cytotoxicity
- Industry Outlook - Pharmaceutical
- Biocompatibility
- Industry Outlook - 黄人导航
- Lab Testing & OOS Investigations
- Product Quality Investigation
- Warning Letter Remediation
- Quality Management System
- Protocol Design for Biologics
- 2021 Industry Outlook - Pharmaceuticals
- 2021 Industry Outlook - 黄人导航
- Data Integrity
- Virtual Audit & Inspections
- Aging Facilities and In-Shoring Product to the US
- Supply Chain Risk Management
- EUA Emergency Use Authorization
- Supply Chain Audit
- Cannabis Regulation
- Outsourcing Surveillance
- Data Integrity & Quality Culture
- AI & Machine Learning in 黄人导航
Testimonials
Events
- Navigating the Decision Flow: Changing Sterilization Modalities for 黄人导航s
- Always Inspection-Ready: Mastering FDA Inspection Preparation and Response
- Understanding PDA/ANSI Standard 06-2025: A Roadmap for Culture Change
- 503A & B Compounding FDA Inspection Readiness and Compliance Training
- Data Integrity In-Person Training Course
- Quality Management Systems In-Person Training Course
- MD&M East 2025
- FDLI Annual 2025
- Navigating Design Challenges, Sterilization Solutions, Lab Testing & Regulatory Compliance for Market Success
