I thought I’d share with you a few things that we believe will impact us immensely. They impact us because they impact you.

1. FDA inspections are undergoing a massive change.

In 2015, approximately 60% of inspections will happen overseas, and this trend will likely continue. Over time, I’d expect the FDA to eventually balance inspections based on the location of manufacturers in the supply chain.

I think industry is also wondering about inspector experience levels. The FDA has hired a ton of new inspectors over the last 5 years, and so a lot of companies are seeing green inspectors – sometimes even as the lead. Can the veterans equip the rookies, in a time of increased complexity, culture, and language barriers? Companies would be well-advised to have deeper inspector intelligence – get a sense for their inspection history, 483 issue rate, specific areas of focus, and whether any of their inspections resulted in warning letters. This is partly why we are developing more comprehensive InspectorRank profiles (more on that soon).

2. The Pharma industry will keep on consolidating.

No surprise here. These massive networks of manufacturing capacity will need to be managed and optimized. The ebb and flow of drugs getting approved, drugs coming off patents, and creative manufacturing partnerships is tricky – companies that can plan flexible manufacturing capacity will be more efficient and save a lot of money.

For GMP regulatory intelligence, many of these merged companies will need to develop or acquire new areas of expertise – bio, drug, API, and combination products. Some regulatory intelligence groups will have to recruit external experts or leverage tools to get up the learning curve quickly.

3. Some facilities based in India and China will catch up quickly, some will continue to fail miserably.

These facilities have been all over the news, but don’t be fooled. Not all of them are created equal – some will continue in their inept ways of cover-ups and incompetence, while others are learning from their counterpart’s mistakes. I can’t tell you how many customers we get – particularly in the last 6 months – that are from India and China. Some are asking the right questions.

Imagine if they had an active program in 2005, and they knew what the FDA and EMA were looking into (data integrity has been cited at companies for more than 10 years!) –  think about the hundreds of millions of dollars damage that could have been avoided. The first major warning letters were issued to Indian manufacturers in 2008. 7 full years later, many of the issues have only multiplied. The next 3 years will reward the winners and punish the losers badly.

4. Internal GMP Regulatory/Quality resources/budgets are shrinking. 

Anecdotally, I’ve heard that many companies are not rebuilding their internal teams. When someone leaves, the position is essentially eliminated. Jobs are combined or less experienced staff fill positions. Of course, when a warning letter is issued, money is thrown around to “address the problem.”

Imagine your manufacturing facilities are a boat. Some companies “address the problem” by actually fixing the broken boat; at other companies, “address the problem” is merely buying the team new buckets to keep bailing out the same old broken boat. The smarter companies are dealing with this problem at its root – by improving intelligence systems and processes and ensuring that their intelligence “data” is quickly converted to actionable “knowledge.”

One thing we will try to do this year is to help you make your case to management. We’ll equip you with data so you can make the case of how dangerous a broken boat is – to your company and ultimately, to patients. I believe that this is a perfect time for teams to identify time-saving, robust, data-driven tools and services. Do more with less. By leveraging tools and expertise, your team can actually work on the value-added analysis, decision-making, and remediation.

So, what did I miss? Do you see other trends for your business that could change your job dramatically?

Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

Webinar: Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

Presented by Jerry Chapman on October 29, 2020

What you will learn:

  • A comparison of 483 observations in FY2019
  • Top 10 Russian Ministry of Health inspection findings
  • Top 10 FDA Warning Letter findings
  • Top MHRA inspection findings
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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

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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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Champion of Change - 3Cs to Success

Webinar: Champion of Change - 3Cs to Success

Presented by Steve Greer on June 23, 2020

What you will learn:

  • The 3C Model to become a champion of change
  • How to identify game-changing habits and the steps to implement them
  • Ways to develop greater purpose-centered leadership
  • How to generate awareness along with actions to create changes in how you think about challenges and change putting you on a path to lead change successfully in your organization
  •  

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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

 

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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

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

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.

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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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Find out what information to include

Review correspondence between sponsor and FDA

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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
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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
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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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