Expert insights from CPGP-certified consultant Jared Clark. Practical guidance on GMP compliance, FDA regulations, cGMP best practices, and the latest industry developments.
What 21 CFR 211.25, Part 111, and Part 117 actually require for GMP personnel training and qualification, and how to close the documentation gaps FDA investigators flag most often.
Learn the specific CFR-mandated testing and monitoring controls that prevent Salmonella contamination in green powders and dried botanicals.
A clause-by-clause guide to 21 CFR Part 352 sunscreen requirements for manufacturers selling OTC SPF products in the US. Get compliant — contact Certify.
A practical guide to batch record review under 21 CFR 211 and ICH Q7, plus the specific findings auditors flag most. Get a compliance gap check.
A clause-by-clause guide to 21 CFR Part 207 foreign drug establishment registration and listing for non-US OTC manufacturers. Talk to Certify Consulting.
A practical guide to GMP cleaning validation: sampling methods, acceptance criteria, and the failures that draw FDA 483s. Talk to Certify Consulting.
Learn how to structure GMP training frequency, documentation, and effectiveness checks that hold up under FDA scrutiny. Book a program audit today.
Learn what FDA and USP require for water system validation (IQ/OQ/PQ), ongoing monitoring, alert limits, and 483 citations. Expert guidance from Certify Consulting.
GMP storage and distribution requirements explained by a compliance expert. Learn what FDA, EU GMP, and USP require — and where most programs fail. Get expert guidance.
Real GMP compliance budget ranges by company size, industry, and cost category. Expert analysis from Jared Clark to help you plan before the FDA shows up. Get started today.
FDA cites the same GMP violations year after year. Learn which violations appear most in 483s and Warning Letters—and how to build systems that prevent them. Expert guidance from Certify Consulting.
GMP quality control testing: methods, validation, OOS investigations, and documentation for FDA-regulated manufacturers. Expert guidance from Jared Clark.
Learn the critical differences between GMP and FSMA for food manufacturers. Expert guidance from a GMP consultant with 200+ clients. Get compliant today.
Jared Clark walks through every phase of GMP compliance — from gap assessment to FDA inspection readiness. Practical, step-by-step, regulation-specific. Get started today.
Master GMP facility design and cleanroom standards before your next FDA inspection. Expert guidance from Jared Clark, 200+ clients, 100% first-time audit pass rate.
Learn GMP supplier qualification procedures that hold up under FDA inspection. Risk-based tiering, approved supplier lists, quality agreements, and audit frameworks. Expert guidance from Jared Clark.
AI tools in pharma must meet 21 CFR Part 11 requirements for audit trails, validation, and electronic signatures. Expert guide from a compliance consultant.
Understand FDA GMP requirements across dietary supplements, pharma, and devices. Expert guidance from Jared Clark at Certify Consulting. 100% first-time audit pass rate.
Learn what GMP training requirements FDA actually expects for manufacturing staff — regulations, documentation, frequency, and how to build a program that holds up under audit.
Master GMP documentation and record-keeping with expert best practices. Avoid 483s, pass audits first time, and build a compliant document system. Get guidance from Jared Clark.
Learn what CGMP failures trigger FDA warning letters for dietary supplement companies — and the quality systems that prevent them. Practical compliance guidance inside.
Learn how to choose the best GMP consultant for FDA-regulated industries. Expert tips from Jared Clark at Certify Consulting. Get your compliance right the first time.
Learn how an FDA GMP compliance consultant navigates 21 CFR Parts 110, 111, and 210/211. Expert guidance from Certify Consulting — 100% first-time audit pass rate.
FDA filed IACM's petition to remove methylene chloride, trichloroethylene & ethylene dichloride from color additive regs. Learn compliance steps & what changes.
Learn what quality systems, lab testing, and manufacturing controls prevent undeclared drug ingredient recalls. Expert GMP compliance guidance from Certify Consulting.
Learn how cold chain breakdowns cause Clostridium botulinum risks in peeled garlic. Practical GMP controls to prevent FDA recalls. Expert guidance from Certify Consulting.
Clostridium botulinum in peeled garlic is a preventable failure. Learn what FSMA temperature controls, cold chain monitoring, and supplier programs keep this hazard out of commerce.
Blueroot Health recalled Vital Nutrients Aller-C for undeclared egg, hazelnut, and soy in a vegan-labeled product. Here is what went wrong and how to prevent it.
Learn what the Blueroot Health Vital Nutrients Aller-C recall reveals about allergen labeling compliance for dietary supplement manufacturers. Practical GMP guidance inside.
A Schreiber Foods almond allergen recall reveals critical labeling gaps. Learn what FDA requires, what went wrong, and how to prevent undeclared allergen violations.
Learn how robust pesticide testing protocols and supplier controls prevent FDA organic food recalls. Expert GMP guidance from Jared Clark at Certify Consulting.
FDA's final order reclassifies melanoma optical diagnostic devices (OYD, ONV) from Class III to Class II. Learn compliance steps, effective dates, and 510(k) requirements.
FDA delayed the effective date for expanded spirulina extract use as a color additive. Learn what changed, who's affected, and how to stay compliant. Updated 2026.
FDA proposes reclassifying TB cell-mediated immunity tests from Class III to Class II. Learn what changes, key deadlines, and how to stay compliant. Expert guidance inside.
When 70% isopropyl alcohol cannot kill the contaminating organism, your upstream controls are all that stand between your product and a nationwide recall. Prevention-focused GMP guidance for OTC antiseptic manufacturers under the new QMSR framework.
The FDA approved Kresladi, the first gene therapy for severe LAD-I. Learn what this means for GMP compliance, CGT manufacturing, and your regulatory strategy.
FDA approved Kresladi, the first gene therapy for severe LAD-I. Learn what this landmark approval means for gene therapy manufacturers and GMP compliance.
Discover how AI and machine learning are revolutionizing GMP quality control. Expert insights from Jared Clark at Certify Consulting. Learn more.
FDA approves Avlayah (tividenofusp alfa-eknm) for Hunter syndrome neurologic symptoms. Learn the GMP compliance and regulatory implications for your business.
A practical guide to validating AI/ML systems under GMP. Learn CSV principles, FDA expectations, and cost-effective paths. Contact Certify Consulting today.
FDA schedules a public meeting on its National Priority Voucher Pilot Program. Learn what this means for your FDA-regulated business and how to prepare. Expert analysis inside.
Schreiber Foods recalled Einstein Bros. cream cheese due to undeclared almonds from a lid-cup packaging mismatch. Learn the FALCPA, 21 CFR Part 117 compliance lessons.
FDA approves 7.2 mg Wegovy semaglutide as the 4th National Priority Voucher product. Learn what this means for GMP compliance, manufacturing, and your regulated business.
Master cGMP validation requirements for equipment and processes. Expert guidance on IQ, OQ, PQ, process validation stages, and FDA compliance. Get audit-ready today.
Expert GMP consulting for pharmaceutical manufacturing facilities. Learn how to achieve compliance, pass FDA audits, and build quality systems that last. Contact Certify Consulting.
Learn exactly what GMP audit preparation services include, how the process works, and what to expect at every stage. Expert guidance from Certify Consulting.
Use this expert GMP compliance checklist for food manufacturers to audit your facility, close gaps, and pass FDA inspections. Built by a certified GMP consultant.
Learn what FDA expects from GMP environmental monitoring programs—sampling plans, alert/action limits, trend analysis, and how to avoid 483 observations. Expert guidance inside.
Learn how to build a GMP CAPA system that satisfies FDA inspectors. Expert guidance on root cause analysis, effectiveness checks, and audit-ready documentation.
Prepare your facility for an FDA GMP inspection with Jared Clark's proven checklist. 100% first-time pass rate. Download the framework today.
Learn which cGMP failures trigger FDA warning letters in dietary supplement manufacturing and how to build systems that prevent violations. Expert guidance inside.
Discover the top FDA warning letter trends in 2026, emerging enforcement patterns, and expert strategies to protect your facility. Free consultation available.
FDA's 2026 final rule standardizes NDC to 12 digits and updates barcode requirements. Learn compliance deadlines and what your team must do now.
Learn the GMP controls, testing protocols, and quality systems that prevent Salmonella contamination in dietary supplements. Expert guidance from Certify Consulting.
Learn what quality systems and testing protocols prevent undeclared drug ingredients in supplements. Expert GMP compliance guidance from Certify Consulting.
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The 90-day, week-by-week plan that takes your facility from “we think we're compliant” to inspection-ready — document inventory, gap assessment, mock inspections, and an inspection-day quick reference.
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