Auditing for Quality Manufacturing: Top Five Areas of Risk for Drug and Device Manufacturers

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Regulators are focused on manufacturers’ quality issues. You only need to look into the issuance of global guidance documents over the past few years: they consistently link data integrity and quality issues/quality culture.

Are you conducting effective audits? Whether your product is on the market or in development, your processes and your business must run smoothly. You can also ensure compliance when you are able to identify and correct these issues before they impact your operations.

Why should you Attend:

Auditing for Quality Manufacturing: Five Areas of Risk for Drug and Device Manufacturers will help you prepare, organize and streamline your audit approach so you can identify quality issues to establish a more robust operation that stands up to regulatory scrutiny. This management report points to five important areas of focus — data integrity, quality culture, aging facilities, investigating manufacturing problems and risk management — in auditing to ensure quality.

In addition, we will cover the five (5) areas where the most risk and how to be prepared for an audit. The five (5) areas covered are below:

Process Characterization


Contamination Control

Process Risk Management


Areas Covered:

The management report explains the key factors that identify a quality manufacturing operation and those that call out quality failures:

  • Understand the definition of and how to evaluate a culture of quality
  • Implement principles of data integrity in manufacturing
  • Utilize a risk-based approach to audits
  • Recognize warning signals that your culture of quality is slipping
  • 55 attributes of a mature quality culture
  • Know what steps to take when a quality issue is identified
  • Recognize impediments to modernization
  • Implement best practices for documenting and tracking resolutions to identified problems
  • Understand principles of quality risk management set by ICH, FDA, WHO and other authorities

Who will benefit: 

Quality Assurance

Quality Control




Quality system auditors

QA directors and managers


Regulatory and Compliance Management

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Speaker: Carl Patterson,

Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.

To date, Carl has now garnered over two decades’ worth of extensive hands-on expertise. Currently, he is the Chief Consultant of his very own consultant business called, where he specializes in the aseptic processing of pharmaceutical products in the pharmaceutical manufacturing sector.

Furthermore, Carl holds various degrees and certifications, including an M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.

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