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Posts by category
- Category: Uncategorized
- Category: All
- Category: News
- Understanding the Knowledge-Aided Assessment and Structured Application (KASA)
- FDA Guidance on Postmarket updates to AI-enabled devices
- FDA ISO13485 Harmonization
- Artificial Intelligence and the FDA
- Medical Device cGMP & QMSR
- Impact of QMS on Quality Maturity
- Artificial Intelligence in Medical Devices
- Postmarket Surveillance: Leveraging Outsourcing
- DHF & Design Controls
- GMP Inspection
- Best Practices for FDA Inspections
- Process Analytical Technology
- Virtual Audits and How to Plan
- MDR Updated Deadlines
- Cytotoxicity Testing
- Brownfield vs. Greenfield Facilities in Pharma
- Addressing Troublesome Design Protocols
- How Brexit is Impacting Medical Device Companies
- Audit & Internal Control
- Post Market Surveillance
- Data Anonymization
- EU Regulatory Update
- Food And Drug Administration
- Inshoring Strategy
- Clinical Trials FDA Guidance
- Medical Device Regulatory Preparation
- IVDR & In Vitro Diagnostics
- FDA Guidance: Continuous Manufacturing
- Quality Culture & The Role of Management
- FDA Machine Learning
- US FDA Inspection
- FDA Guidance: Drug Approval
- EU IVDR Deadlines
- Category: Events
- MD&M East 2025
- FDLI Annual 2025
- Quality Management Systems In-Person Training Course
- Interphex 2025
- Data Integrity In-Person Training Course
- PDA Annual 2025
- AAPS PharmSci 360
- CPhI North America 2024
- MD&M West 2025
- PDA/FDA Joint Regulatory Conference 2024
- MD&M Minneapolis
- BIOMEDevice Silicon Valley 2024
- Category: Press Releases
- Category: Insights
- How the New U.S. Administration is Reshaping MedTech and Pharma Regulations
- Strategic Consulting Services
- Remediation Consulting Services
- Compliance Consulting Services
- Regulatory Compliance Services
- US FDA Consultants
- Quality Assurance Services
- Pharmaceutical Supply Chain Consulting
- Pharmaceutical Consultants
- Life Science Consultants
- Category: News
- Category: Blog
- What to Expect During an FDA Inspection
- FDA’s QMSR Final Rule: What Manufacturers Need to Know
- Leveraging Outsourced Staff
- Crisis Management Playbook
- Outsourcing Post Market Surveillance and Support
- Cell and Gene Therapy Development
- Microbial Process Design
- Pharmaceutical Supply Chain
- Cannabis Business Trends
- Product Development
- How Quality Culture Is Changing
- FDA Guidance: GASK
- Cyber Awareness for Consumers
- Medical Device Cybersecurity Guidance
- Compliance & Product Launch
- Medical Device Cybersecurity
- In-Vitro Diagnostic Devices Regulation (IVDR)
- FDA Medical Device Guidance
- Biocompatibility Testing
- Data Integrity
- Pharmaceutical Manufacturing
- FDA Harmonization
- Cannabis Business Success
- Emergency Use Authorization: Benefits and Risks
- Supply Chain Management: Avoiding Interruptions
- The Regulatory Impact of EUAs
- Medical Device Testing
- FDA Expands Virtual Audit Guidance
- FDA Updates Supply Chain Security Guidance
- FDA Inspectional Approach
- FDA Guidance: Product Lifecycle
- FDA Guidance: Data Integrity
- FDA Publishes Updated Biologics Guidance
- Cannabis Regulation
- Quality Control & Data Integrity
- Waterfall Methodology
- Quality Management Summit
- Category: Pharmaceutical
- Category: Medical Device
- Category: Biologics
- Category: Recent News Carousel
Locations
White Papers
- Product Launch & Lessons Learned
- Medical Device: Clinical Evaluation Requirements
- IVDR Regulation for EU
- Internal Audit: Be Ready For FDA Inspections
- GMPs for Early Stage Development Projects
- FDA Regulatory Pathways for Medical Device
- 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
- Navigating Design Challenges, Sterilization Solutions, Lab Testing & Regulatory Compliance for Market Success
- The Future of MedTech and Pharma Under the New Administration
- Navigating the FDA's Medical Device Pre-submission Process
- EU Market Authorization for Sterile Medical Devices
- 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’s Quality Management Program
- Quality Metrics: Essential to Quality
- FDA Medical Device Inspections
- On-Site Inspections: They’re Back — 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
- Quality Management System
- Pharmaceutical Packaging
- Sterile Compounding Pharmacy
- Biologics Manufacturing: Design & Build Out
- ISO Compliance Audit
- Biosimilar Drug Development
- MDR Regulatory Submission
- Quality Assurance Outsourcing
- Pharmaceutical Validation Study
- Portfolio Risk Management
- Outsourcing Pharmacovigilence
- Biotech Warning Letter
- Quality System Development
- Compliance Audit
- Manufacturing Automation for Medical Devices
- FDA Warning Letter
- Process Validation
- Endotoxin Control
- FDA 510(k)
- Regulatory Due Diligence
- Compliance Assurance & FDA Inspection
- Pharmaceutical Development and Regulatory Submission
- CBE30 Regulatory Strategy
- 21 CFR Part 11 Gap Analysis
- FDA 483 Warning Letters
- Document Management System
- CAPA Processes & Preventative Action
- Product Launch Plan
- Product Development Process
- Pre-Acquisition Technical Due Diligence
- FDA 483 Warning Letter Remediation
- DHF Design History File Remediation
- Medical Device Validation: Shelf Stability
- Brand Name Re-Registration with New Logo
- CE Mark: Clinical Evaluation
- Biotechnology Process Control
Published Articles
- Drug Shortages and Complying with FDA’s 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
- CE Mark: Clinical Evidence Requirements
- 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’s 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 Medical Devices
- Conducting an Internal Audit
- Quality Inspection: Making the Most of Your Processes
- Biologics Investigation
- Strategies for Contamination Control
- 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 Medical Device Regulatory
- Strategic Lifecycle Approach to Medical Device 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
- Elements for a Sustainable Environmental Monitoring Program
- ALCOA and ALCOA+
- FDA Audit & Inspection Model
- Lessons Learned From Investigations of Product Failures
- Medical Device Cybersecurity
- FDA 483 Trends
- Technology Transfer Pharmaceutical
- Creating Robust CAPA Systems
- Internal Audit
- FDA Looks to Industry for Collaboration and Harmonization
- 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
- Medical Device Info Sheet
- Quality Culture
- Medical Device Regulatory Services
- ISO 13485 & 21 CFR 820
- EU MDR Implementation
- Design History File Info Sheet
- Outsourcing Quality & Regulatory
- FDA Medical Device Services
- Lessons Learned from Combination Products
- MDR Consultant Services
- Pharmaceutical Consultants Info Sheet
- Biologics Info Sheet
- Medical Device 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
- Margaret Harvey
- Justin Anahory
- Elizabeth Morack Tews
- Brandon Miller
- Beth Edick
- Dean Coston
- Shereen Theisen
- Gina Desimone
- Nicole Therrian
- Tanner Mordja
Podcasts
- 2025 Medical Device 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 - Medical Device
- Lab Testing & OOS Investigations
- Product Quality Investigation
- Warning Letter Remediation
- Quality Management System
- Protocol Design for Biologics
- 2021 Industry Outlook - Pharmaceuticals
- 2021 Industry Outlook - Medical Device
- 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 Medical Device
Industries
Services
- Preparation and Training-Device
- Oversight Services-Pharma
- Portfolio Management-Pharma
- Manufacturing Optimization and Aging Facilities-Pharma
- Services Supported by Partners-Device
- Manufacturing Optimization and Aging Facilities-Device
- Part 11 and Computerized System Validation-Device
- Manufacturing and Facility Validation-Device
- Technical File and Design History File-Device
- Strategic Consulting-Device
- Staffing Support-Device
- Compliance Assurance-Device
- Assessments-Device
- Audits-Device
- Regulatory Agency Action Response-Device
- Other Regulatory Services-Pharma
- Quality Assurance-Device
- Remediation Strategy and Support-Device
- Data Integrity-Device
- Regulatory Action-Device
- Other Regulatory Services-Device
- Mergers & Acquisitions Support / Due Diligence-Device
- Other Services
- Biologics
- Combination Products
- Compounding Pharmacies
- EU Medical Device Regulations
- Outsourced Quality Support-Device
- Medical Device Single Audit Program (MDSAP)
- ISO 13485:2016
- Manufacturing and Facility Support-Pharma
- Compliance Assurance-Pharma
- Quality Assurance-Pharma
- Remediation Strategy and Support-Pharma
- Strategic Consulting-Pharma
- New Product Support-Device
- Post Approval Support-Device
- Preparation, Training, and Inspection Readiness-Pharma
- Regulatory Agency Response-Pharma
- 21 CFR Part 210 & 211 Remediation-Pharma
- Assessments-Pharma
- Audits-Pharma
- Change Management-Pharma
- Data Integrity-Pharma
- Laboratory Support-Pharma
- Regulatory Affairs-Device
- Master Validation Plan-Pharma
- Mergers & Acquisitions Support / Due Diligence-Pharma
- New Product Development-Device
- Part 11 & Computerized System Validation-Pharma
- Product Life Cycle Management-Device
- Quality System Automation Using Software-Pharma
- Quality System-Device
- Regulatory Action-Pharma
- Staffing Support-Pharma
- Medical Device
- Pharmaceutical
- Regulatory Affairs-Pharma
- New Product Support-Pharma
- Life Cycle Management-Pharma