Morf Media Chief Compliance Officer Presented Quality Metrics Update at PRCSQA 2015

Share Article

Angela Bazigos Discussed FDA Direction to Move from Compliance to Quality

Angela Bazigos, Chief Compliance Officer, Morf Media Inc.

We have to be efficient. Effective training is key. In fact, I advocate bringing training to the Boardroom. Linking training goals to executive compensation. Ultimately improving quality is at the heart of meeting compliance goals.

Morf Media Inc., today announced that at the Pacific Regional Chapter of the Society for Quality Assurance (PRCSQA), Angela Bazigos, Morf Media Inc. chief compliance officer and former chair of the PRCSQA presented an update on quality metrics. Bazigos spoke about the FDA goal of strengthening their efforts to ensure that FDA-regulated products are not only demonstrated to be safe and effective—i.e. meet compliance, but also continually manufactured under strict quality standards.

In her talk, Bazigos asked if the focus on regulatory compliance causes drug makers to lose sight of quality. By establishing an Office of Pharmaceutical Quality, she noted that the FDA hopes to spur pharmaceutical manufacturers to address batch process, packaging, and other problems impacting the supply chain. This lack of focus on quality has resulted in recalls, drug shortages, and other impacts on consumers.

With the increase in field alert reports, recalls have increased dramatically, and drug shortages due to component problems, delays, and capacity issues (quality) are increasing as well. “While the pharmaceutical industry itself is ultimately responsible for quality, and some plants are improving facilities, modernizing control platforms and process technologies, and rolling out quality-by-design (QbD) programs, the facts do not support the idea that there has been real improvement,” said Bazigos. “Take a cancer patient on a pretty special drug,” for example. The plant is registering 50 percent of batches failing. Does that sound like a validated process to you? With that many batches failing, you start running into availability issues. But a Form 483 is not going to get that drug in the patient’s hands any faster.”

Industry sources pointed out that other industries, like automotive, hospitals, and foodservice, measure things like employee turnover, hours of training, etc., to gauge quality. “The question is, are high training hours an indication of a commitment to quality, or do they signal repeated failures and employees taking longer to learn? What about the ratio of quality people on the team compared to manufacturing people? What is a good ratio? What ratio might trip an alarm?

Bazigos added: “We have to be efficient. Effective training is key. In fact, I advocate bringing training to the Boardroom. Linking training goals to executive compensation. Ultimately improving quality is at the heart of meeting compliance goals. FDA believes a careful analysis of quality metrics can help its agency better identify which facilities are at the highest risk for quality problems. Quality is also directly connected to a consistent supply of needed medications. The FDA believes that a company’s own robust quality measurement system, along with their quality measurements, can help manufacturers better identify factors that may predict manufacturing problems – and move us a step closer toward reducing and controlling these disruptions—which can help improve the quality of life for patients if not save lives.

About Morf Media, Inc.
Morf Media, Inc. is the developer of Morf Learning™ and soon-to-be released Morf Playbook™, the game-changing training delivery platform, made easy, fast and fun. For the first time companies can provide one to one customized online training to their mobile workforce, partners and customers on a smart phone or tablet. Founded in 2013 by a seasoned management team, the company is based in San Francisco.

For more information, please visit http://www.morfmedia.com.

Contact:
Heidi Wieland
Vice President Marketing of Morf Media, Inc. USA
805-722-7413
Heidi(at)morfmedia.com

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Heidi Wieland
Morf Media
+1 805-722-7413
Email >
Visit website