ComplianceOnline

Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues

Instructor: Gregory Martin
Product ID: 705347
  • 21
  • February 2018
    Wednesday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 90 Min

Live Online Training
February 21, Wednesday 10:00 AM PST | 01:00 PM EST | Duration: 90 Min

$139.00
$199.00 (30%)
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One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
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recorded version

$249.00
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Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$349.00
One CD/USB is for usage in one location only.
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CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD/USB

$449.00

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Read Frequently Asked Questions

This webinar will discuss in detail the fundamentals of data integrity including the FDA guidance document. It will teach attendees practical steps to identify and avoid data integrity issues in pharmaceutical laboratory.

Why Should You Attend:

Data integrity is fundamental in a Pharmaceutical Quality System which ensures that medicines are of the required quality. This requires an understanding the expectations for data integrity from a CGMP perspective. Reviewing FDA guidance documents and citations in FDA warning letters will facilitate this understanding. Providing practical steps which can be taken will help your organization reduce the likelihood of receiving a Warning Letter due to Data Integrity issues.

Upon completion of this course the learner should:

  • Understand what Data Integrity is, and why it is so important.
  • Be familiar with regulatory expectations for laboratory notebooks and computer systems.
  • Be familiar with issues that resulted in warning letters from the FDA.
  • Understand some practical steps that can be taken to facilitate good documentation and reduce the likelihood of receiving a warning letter for data integrity issues.

Areas Covered in the Webinar:

  • What is meant by ‘Data Integrity’?
  • Data integrity expectations from the FDA guidance
  • Discussion on computer systems, notebooks and spreadsheets
  • FDA warning letters citing data integrity issues
  • Practical steps you can take to avoid being cited
  • Questions and discussion

Who Will Benefit:

  • Quality Control Personnel
  • R&D Scientists
  • Laboratory Supervisors and Managers
  • Quality Assurance Personnel
  • Chemists/Managers
  • Regulatory Affairs Personnel
Instructor Profile:
Gregory Martin

Gregory Martin
Founder and President, Complectors Consulting LLC

Gregory Martin is President of Complectors Consulting (www.complectors.com), which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years’ experience in the pharmaceutical industry, including Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company to solving challenging problems. He provides consulting services to over 50 companies, including human and veterinary pharmaceutical companies, manufacturers of OTC and nutritional supplement products, and contract organizations.

In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters – Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He also serves on the Steering Committee of the AAPS IN Vitro Release and Dissolution Testing Focus Group.

He has particular interest in QbD/Lean approaches to dissolution testing, method lifecycle (development/validation/transfer), impurity testing and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is has presented at several scientific meetings, and authored of several papers in the areas of dissolution and analytical method validation.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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