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Featured Product In Inspections and Audits

FDA’s Alternative Inspection Tools

FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions

$397.00
If you want to pass your next inspection, FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions is a must. Read More

Inspections and Audits

Kalah Auchincloss, JD, MPH, and Madeleine Giaquinto, JD -green600

CBER’s Five-Year Plan: Address the Agency’s New Priorities and Stay Compliant in a Post-COVID-19 World – Webinar Recording/Transcript

$287.00
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Risk-Based Supplier Qualification

Risk-Based Supplier Qualification: Finding the Right Vendors for the Most Critical Supplies

$397.00
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Teresa Gorecki and Kenneth Ray- green600

Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives – Webinar Recording/Transcript

$287.00
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David L. Chesney, MSJ - red 600

Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections – Webinar Recording/Transcript

$287.00
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Robert Brooks

Biopharmaceutical Supply Chain Issues Before, During and After the Pandemic – Webinar Recording/Transcript

$287.00
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Howard Sklamberg - aqua

FDA’s Big Global Quality Harmonization Dilemma – Webinar Recording/Transcript

$287.00
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Kellie Combs and Sarah Blankstein - green

CDER’s Most Significant Guidance Priorities for 2021 – Webinar Recording/Transcript

$287.00
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Drugmaker’s Guide to Process Validation: Principles, Methods and Compliance

Drugmaker’s Guide to Process Validation: Principles, Methods and Compliance

$397.00
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Cynthia Schnedar and Dawn Wynder -purple

Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19 – Webinar Recording/Transcript

$287.00
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Kalah Auchincloss - green

FDA Drug GMP Facility Inspections During the Pandemic – Webinar Recording/Transcript

$287.00
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Susan-Schniepp--Seyed-Khorashahi-Steven-J-Lynn-teal

Effective Auditing for Manufacturing Quality – Webinar Recording/Transcript

$287.00
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Wayne Pines, Marc Scheineson, Esther Krofah, Lowell Schiller -purple

FDA Under the Biden Administration: What’s to Come and What It Will Mean – Webinar Recording/Transcript

$287.00
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