Over the years, the Redica blog (formerly Govzilla) has published over 725 articles covering a breadth of topics including:

And, more.

To serve as a resource for you and your company and to help orient you to the scope of the Govzilla blog, we assembled a list of some of our most useful, relevant, and popular articles of all time.

  1. The FDA And MHRA’s Most Recent Drug Inspection Observations: A comprehensive GMP Intelligence program includes monitoring of health authority enforcement actions.
  2. The Ultimate Guide To Form FDA 483s: Go beyond the basics of the Form FDA 483 and learn all you need to know.
  3. Data Integrity Trends In 483s And Warning Letters: Part 1: The FDA cited data integrity on 79% of drug Warning Letters over the last 5 years.  If you cannot trust the data of the process and its results, then can you really trust anything?
  4. FDA: How Pharma Companies Are Unknowingly Introducing Risk Into Their Quality Management Systems: Consumer Safety Officer Emilie Kahn shares her take on the increased risk that companies are unknowingly introducing into their quality risk management (QRM) systems.
  5. FDA Cites Part 11 In Clinical Trial – We all “know” FDA doesn’t cite Part 11 in 483s, right?  Well, maybe.
  6. 28 Unique Data Integrity Deficiencies That Aren’t Really Unique – See specific data integrity citations from over the years that may not be as new as you think.
  7. Top 10 Responsibilities Of The Pharma Quality Unit – We compiled this list from FDA regulations and guidance documents that define the job of the Quality Unit. After all, the Quality Unit is the only job description that appears in the Code of Federal Regulations!
  8. 5 Features to Look For in an EIR – An EIR provides a wealth of information regarding the site, conduct, and outcome of an inspection. It is particularly useful for firms to understand what areas the FDA focuses on and how the FDA reviews documents.
  9. 10 Ways For Small And Virtual Companies To Prepare For A GMP Inspection – Following are our 10 suggestions for these firms to ensure a successful inspection outcome when they have limited experience in this activity and limited resources.
  10. Why Did McKesson Receive The First DSCSA Warning Letter? – First-of-a-kind enforcement actions are always of interest in terms of what they tell us about the FDA’s potential future enforcement in an area.
  11. MHRA’s “Right Environment” – Former FDA Investigator Peter Baker explains his belief that Quality Culture and data integrity are intrinsically connected based on MHRA’s concept of “right environment”.
  12. The Ultimate Guide To Researching Your FDA Inspector – Are you fully inspection-ready without knowing anything about your inspector?  We walk through 8 steps to help you and your team prepare before your inspector arrives.
  13. Repeat Deficiencies In Lupin Limited Warning Letters: Lupin Limited (India) came up short on both taking a global view to remediation as well as addressing issues at all sites.
  14. Identification Of Software Validation Shortcomings: Why doesn’t FDA commonly cite ‘lack of software validation’ as a deficiency” to drug manufacturers? 
  15. How To Talk So That FDA Will Listen, And How To Listen When They Talk: Advice That Could Be Worth Millions: Having a strong data package including extensive product and process knowledge is critical to getting a new drug approved, but by itself may not be enough. 
  16. COVID-19 Pandemic And Your GMP Audit Schedule For 2020: Bottom line, supply chain issues will be with us in unexpected ways during this public health crisis. Take a look at the GMP audit program and some options that may be able to help mitigate risk in this area.
  17. Overview: 2018 MHRA GMP Inspection Deficiencies: This article provides a high-level overview of the 2018 data, and we will do a later follow-up report including additional granularity and trends over the past few years.
  18. CDER Warning Letter Trends By Facility Type: Recently, the CDER warning letter issuance skyrocketed from 70 in FY2014 to 128 in FY2018, an increase of 83%. What types of firms are taking the heat? And where are they located?
  19. FDA Expanding Its Sterile Drug NIPP Inspection Pilot To Include Other Dosage Forms: Alonza Cruse explains that the pilot phase for NIPP for inspections of sterile drug products has concluded, and FDA will be using the model for inspections of other drug product types.
  20. Deep Pockets | Does The FDA Get Tougher If The Owner Gets Richer?: We provide five recent examples where the FDA appears to increase their enforcement intensity when an acquiring firm with perceived ‘deep-pockets’ enters the game.

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What You Will Learn from This Report:

How a major pharmaceutical company designed a program to train future leaders in quality

An industry-led initiative to advance the state of quality in the pharma industry

A pharma GMP leader’s tips for supporting quality culture within an organization

An update on FDA’s Quality Maturity Model

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Compare two companies of your choice.

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Evaluate Your CDMOs

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Compare the inspection history of your CDMO sites.

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Compare the enforcement history of your CDMOs.

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Monitor compliance at your Clinical Investigator sites.

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Prepare for inspections of Clinical Investigator sites.

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Prepare for your next inspection.

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Prepare for your next inspection.

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Prepare for your next inspection.

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Get help choosing the right CRO.

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Download your copy of THE FDA INSPECTION LANDSCAPE IN MID-2020 AND A LOOK AT VIRTUAL INSPECTION

In this summary we identify:

  • Trend analysis of FDA inspections through mid-2020
  • Strategies for preparing and hosting virtual inspections
  • New technologies to support remote inspections
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In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

Panel Discussion – Remote Audits

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Featuring 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.

Turning Failure into Success

Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble

What you will learn:

  • How to use the Leadership SOS Model to transform quality culture
  • How to strengthen quality systems to eliminate human error
  • How to generate ideas on how to set your organization up for success for shareholders, FDA, and staff
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Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

Get instant access to the webinar video and slides.

What you will learn:

  • Common challenges small pharma firms face when developing a QMS
    Recent enforcement trends involving the Quality Unit
    Impact of the COVID-19 pandemic

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In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

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An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

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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

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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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Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Webinar: Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Presented by Paul Smith, Agilent Technologies on Aug. 26, 2020

What you will learn:

  • Examples of essential laboratory actions to remain compliant during the pandemic
  • Recent data integrity non-compliance findings and trends
  • Essential strategies to find, understand, and leverage regulatory non-compliance data

Get the scoop on recent data integrity 483 observations!

  • FY 2020 Data Integrity 483 Observations
  • Data Integrity Observations for Human Drugs
  • Observations Falling Under GMP
  •  

Past, Present, and Future of Quality Culture

Presented by Regulatory Compliance Associates Distinguished Fellow Susan Schniepp

What you will learn:

  • How the 2014 FDA quality metrics initiative led to greater focus on quality culture
  • New quality culture tools and standards under development by PDA and other organizations
  • Best practices for quality culture, including case studies with lessons learned

Changing Medical Device Regulations

Presented by Redica Systems 

What you will learn:

  • The latest developments regarding the EU MDR
  • Quality Systems requirements for medical devices
  • Regulatory updates affecting medical devices

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Combination Product Report

What You Will Learn from This Report:

The latest U.S. and European regulatory developments

The impact of smart combination products

How the EU MDR impacts drug-device combination products

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5 GMP Case Studies Report

What You Will Learn from This Report:

In-depth analysis of the findings

Lessons learned

How companies can avoid similar shortcomings.

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Redica Systems Expert Jerry Chapman to Present at SQA Annual Meeting

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.

Download the 510(k) Sample

What You Will Learn from This Sample:

See how a 510(k) submission is structured

Find out what information to include

Review correspondence between sponsor and FDA

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5 GMP Case Studies Report

What You Will Learn from This Report:

The first countrywide import alert issued by FDA

An inadequate deviation investigation

An inadequate product specifications and a product recall

Process validation issues at a CMO

A different perspective on process validation and the culpability of the quality unit

 

A.I. for Quality and Compliance Teams

August 3 webinar

Presented by Redica Systems Senior GMP Quality Expert Jerry Chapman

What you will learn:

  • A basic understanding of data sources, machine learning, NLP, and A.I. tools
  • Building and applying Expert Models
  • Two case studies, one on sterile manufacturing/503B and one on data integrity

Human Factors – Compliance and Applications

June webinar

Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and  Human Factors, Kaleidoscope Innovation 

What you will learn:

  • Human factors strategies from simple drug products to complex surgical devices
  • Primary and secondary labeling development and evaluation for usability
  • Human factors activities from product development to post-market
  • International strategies: expectations for human factors in regulatory submissions in international markets

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Keep up with the latest Regulatory Developments on Clinical Trials

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Save your team valuable time when using External Monitoring.

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Save time and Resources when using External Monitoring.

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See how we can help you eliminate yet another spreadsheet.

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Stay ahead of changing regulations.

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Upgrade your CDMO monitoring strategy.

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