Since the COVID-19 pandemic began, the pharma/biopharma and medical device industries have switched to remote audits in lieu of traditional onsite audits.  This has required firms and regulatory agencies to tackle new approaches. 

Recognizing this, Redica Systems will host a virtual panel discussion Tuesday, May 18 at 1:30 p.m. EST on remote audits.  A panel of experts will share their thoughts and perspectives on remote audits.  Registrants can also submit questions that will be given to the speakers ahead of the panel.

Click here to register and submit your questions for the panel.  

Following the panel, all registrants will receive an email with a link to the recording, even if they were not able to attend.

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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.

About the Panelists

Barbara Unger

Barbara Unger formed Unger Consulting, Inc. to provide GMP auditing and regulatory intelligence services to the pharmaceutical industry.  Her auditing experience includes leadership of the Amgen corporate GMP audit group for APIs and quality systems.  She also developed, implemented, and maintained the GMP regulatory intelligence program for eight years at Amgen.

Jerry Chapman

Jerry Chapman is a Senior GMP Quality Expert at Redica Systems.  He writes the Redica Systems blog “Conference Spotlight” and is working on machine learning models for analysis of agency enforcement documents.  He brings 40 years’ experience in the pharma industry, including 31 years at Eli Lilly in technical and leadership positions in research and product development, manufacturing, plant quality, site quality, corporate quality, and quality systems.

Stephanie Gaulding

Stephanie Gaulding is the Executive Director, Regulatory Compliance at Pharmatech Associates, Inc., a consultancy serving the regulated life science industry.  She draws on over 25 years of experience in quality management systems and leadership roles in the regulated life science industry to develop and deliver efficient and sustainable quality management systems, assuring compliance with global regulatory requirements and industry best practices.

Redica Systems Senior GXP Specialist Jason Kerr will moderate the panel.

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

In this summary we identify:

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

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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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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

Panel Discussion – Remote Audits

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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.

Download the Special Report

CDMO Comparison opt-in

In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

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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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Prepare for your next inspection.

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Prepare for your next inspection.

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Prepare for inspections of Clinical Investigator sites.

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Monitor compliance at your Clinical Investigator sites.

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Compare the enforcement history of your CDMOs.

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Compare the inspection history of your CDMO sites.

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Redica Systems Enforcement Analytics

Upgrade your inspection strategy.

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Upgrade your inspection strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need.

Experience the Power of Redica Systems

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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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