Expert insights from CPGP-certified consultant Jared Clark. Practical guidance on GMP compliance, FDA regulations, cGMP best practices, and the latest industry developments.
Learn the GMP controls, fill-level testing protocols, and quality systems that prevent FDA beverage recalls. Practical guidance from a GMP compliance expert.
Clostridium botulinum in peeled garlic is a preventable failure. Learn what FSMA temperature controls, cold chain monitoring, and supplier programs keep this...
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...
A practitioner's guide to evaluating GMP consultants. What credentials matter, which red flags to watch for, and how to match a consultant to your specific CFR...
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)...
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...
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...
Learn the quality systems and microbial controls that prevent contamination in alcohol prep pads. Practical GMP guidance for FDA-regulated manufacturers.
When 70% isopropyl alcohol cannot kill the contaminating organism, your upstream controls are all that stand between your product and a nationwide recall...
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.
Discover how machine learning is reshaping GMP quality control in FDA-regulated manufacturing. Expert insights from Jared Clark at Certify Consulting.
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...
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...
FDA approves 7.2 mg Wegovy semaglutide as the 4th National Priority Voucher product. Learn what this means for GMP compliance, manufacturing, and your...
Learn what GMP controls, visual inspection protocols, and manufacturing systems prevent wrong-drug mix-ups in injectable manufacturing. Prevention guide for...
Master cGMP validation requirements for equipment and processes. Expert guidance on IQ, OQ, PQ, process validation stages, and FDA compliance. Get audit-ready...
Expert GMP consulting for pharmaceutical manufacturing facilities. Learn how to achieve compliance, pass FDA audits, and build quality systems that last...
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...
Learn what FDA expects from GMP environmental monitoring programs—sampling plans, alert/action limits, trend analysis, and how to avoid 483 observations...
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...
Learn what quality systems, testing protocols, and manufacturing controls prevent FDA dietary supplement recalls. Expert GMP compliance guidance from Certify...
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 what mycotoxin testing, supplier controls, and FSMA-compliant quality systems would have prevented the 2026 patulin recall. Expert guidance from Certify...
Learn the GMP controls, testing protocols, and quality systems that prevent Salmonella contamination in dietary supplements. Expert guidance from Certify...
Learn what GMP systems, testing protocols, and manufacturing controls prevent Listeria contamination in dairy products. Prevention-focused guidance from Jared...
A 2026 chicken chip recall exposes critical pet food GMP gaps. Learn which quality systems, testing protocols, and FSMA controls prevent Salmonella recalls.
Learn what GMP controls, testing protocols, and quality systems prevent FDA recalls for undeclared drug ingredients in dietary supplements. Expert guidance...
Learn what quality systems and testing protocols prevent undeclared drug ingredients in supplements. Expert GMP compliance guidance from Certify Consulting.
Get expert GMP consulting insights, FDA regulatory updates, and compliance tips delivered directly to your inbox. No spam, just actionable guidance for manufacturers.
Newsletter coming soon. Follow us on LinkedIn in the meantime.
Schedule a free consultation with Jared Clark, JD, MBA, PMP, CMQ-OE, CPGP, CFSQA, RAC. We'll assess your compliance status and build a clear roadmap to audit readiness.