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

Duration : 60 Minutes

Carl Patterson, MS, SSGB, SSBB,

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 Read more

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.

Course Objectives:

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
• Investigations
• Contamination Control
• Process Risk Management
• Documentation

Course Outline:

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

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Assurance
• Quality Control
• Production
• Logistics
• Manufacturing
• Quality system auditors
• QA directors and managers
• Consultants
• Regulatory and Compliance Management

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


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