‘Scary World’ of Generic Drug Manufacturing, Revealed
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Medscape Article: ‘Scary World’ of Generic Drug Manufacturing, Revealed
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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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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.
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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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
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
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
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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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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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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
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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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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What You Will Learn from This Report:
In-depth analysis of the findings
Lessons learned
How companies can avoid similar shortcomings.
Experience the Power of Redica Systems
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
Unlimited Access to Reports and Data
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A.I. for Quality and Compliance Teams
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
Human Factors – Compliance and Applications
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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Discover the power of the most comprehensive database of 483s in existence.
Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.
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