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
The management report explains the key factors that identify a quality manufacturing operation and those that call out quality failures:
Who will benefit:
• Quality Assurance
• Quality Control
• Quality system auditors
• QA directors and managers
• Regulatory and Compliance Management
Duration: 60 Minutes
Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version
Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
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 aseptic-process.net, 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.