REGULATORY FOCUS
Scope of FDA Draft Guidance on Nonbinding Feedback is Too Restrictive, Industry Argues
THE WALL STREET JOURNAL
Open-Government Laws Fuel Hedge-Fund Profits
Hedge Funds Are Using FOIA Requests to Obtain Nonpublic Information From Federal Agencies
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Please submit your email address and one of our team members will contact you shortly to answer all of your questions and get you started with the new Enforcement Analytics platform.
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SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.
WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject
SITES Quickly assess inspection records including dates and inspectors across all of your sites
INSPECTIONS Complete list of FDA inspections by date, company, category, and country
In this summary we identify:
In this summary we identify:
GMP data from FY2017 to FY2020 for the Asia-Pacific region
Top 3 GMP primary and secondary citations
Presented by Fenton Fong, Founder, Managing Director, & Principal at xCellarate
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What you will learn:
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Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble
What you will learn:
Tuesday, May 18, 2021
10:30 AM PST / 1:30 PM EST
Secure your spot for this informative 1-hour Panel Discussion among experts sharing their thoughts and perspectives on Remote Audits.
Can’t make the discussion?Register and we will send you a post-show recording.
Panelists:
—Barbara W. Unger, Unger Consulting, Inc.
—Jerry Chapman, Redica Systems
—Stephanie Gaulding, Pharmatech Associates
Who Will Benefit?
This session will be valuable to GMP quality, regulatory, compliance, and management personnel in FDA-regulated industries who want to have a conversation on remote audits and get to know what is going on in the industry.
In this summary we identify:
FY2018-FY2020 GMP data for Lonza & Catalent
Top GMP primary citations
Top FDA 483 observations
In this summary we identify:
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INDEX INFORMATION Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.
STRENGTHEN DATASETS Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.
ANALYZE & INTERPRET PATTERNS Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.
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Sign up for your FREE account today and get instant access to:
SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.
WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject
SITES Quickly assess inspection records including dates and inspectors across all of your sites
INSPECTIONS Complete list of FDA inspections by date, company, category, and country
Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.
Eliminate days of work and get your FREE personalized 483 Observation Report.
