Life Sciences – with tabs

Corrective and Preventive Action – Program Overview:

Analysis of investigation reports reveal that human error is one of the top root causes for deviations, discrepancies and quality incidents in pharmaceutical manufacturing. And when you examine the CAPA’s that are developed from these, retraining and rewrite of SOP is top the list. Yet on further re-examination, you find that these problems keep resurfacing again and again. Put in another way, the CAPA’s are ineffective. Does it mean that the CAPA’s were wrong or is it pointing to another problem? Namely, that the investigation did not pinpoint the root cause of or most probable contributing factors to the problem. Most often “human error” is not really the problem but a symptom of a system or facility or operation that is not designed to be run by humans. Humans do contribute to problems but more often than not, because what we are asking them to do is not designed with humans in mind. So a true CAPA should be developed to solve the problems with the system, facility and operation rather than focus on remediation of people. This requires investigations to focus on getting to the real root cause and contributing factors. Click here to read more, or Buy Now

Every day within the EU, businesses, public authorities and individuals transfer vast amounts of personal data across borders. Conflicting data protection rules in different countries would disrupt international exchanges. Attendees will learn the common EU rules that have been established to ensure that personal data has a high standard of protection across the EU. Attendees will also learn about their rights to complain and obtain redress if their data is misused in any of the EU member states. Individuals in the EU may be unwilling to transfer personal data outside the EU if they are uncertain about the level of protection in other countries. How US businesses need to pay attention to this impact will be addressed. Click Here to read more or Buy Now

Establishment Registration and Listing:

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Overview of Regulatory for Medical Devices:

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Quality Metrics – Latest Advances:

There has been a tremendous 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. Industry itself is ultimately responsible for quality, of course. But while 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. Industry’s position is “all the FDA cares about is compliance to GMPs [good manufacturing practices]. You don’t care about quality.” GMPs do matter and, at least in theory, quality is covered in the GMPs. But the agency is thinking that compliance may have become such a focus that drug makers are not sufficiently concentrating on quality—quality of the process, the batch, the packaging, and the distribution. This lack of focus on quality has resulted in recalls, drug shortages, and other impacts on consumers. To address this issue, FDA has now established an Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand-name, generic, and over-the-counter drugs, and is calling on industry to offer up metrics to prioritize field investigations. This presentation gives the context for the quality metrics, discusses the draft guidance issued for comment by the FDA and gives the results of FDA and industry discussions to date. Click here to read more or Buy Now

Reasons to Choose PHONIZE  Social Training Platform for the Mobile Workforce


Life sciences companies are committed to innovation, product quality and patient safety, but a rapidly changing and tightening regulatory environment, global manufacturing and distribution, increasing cost pressures and supply chain complexities bring new challenges even as you read this. Emerging global markets, quality initiatives, and increasing mergers and acquisitions activity add to the complexity of meeting compliance in life sciences manufacturing and distribution.

Effective, ongoing training is a crucial part of meeting the regulatory requirements across local, regional and global supply chains. Training is essential for running a successful and profitable company; in fact we believe compliance training drives strategic advantage. 

 PHONIZE™ is the World’s Easiest to Use Mobile & Social HR Talent Development Platform     

The life sciences industry thrives on innovation and technological advances. Keeping employees, management and the Board up to speed on changes in industry best practices and other developments has been challenging but doesn’t need to be unwieldy anymore. PHONIZE and our industry training experts have already done the heavy lifting of developing effective training on a platform, that for the first time, can reach all of your stakeholders, partners, employees and investors–all with a few clicks on their mobile device of choice. With easy Word-like authoring for instant course updates and deployment and secure centralized reporting access, PHONIZE offers next generation compliance training system capabilities for companies like yours.

Our mission is to help life sciences companies reach their entire workforce and supply chain with individualized learning and tracking capabilities. That’s how PHONIZE is shaping the future of training for companies in medical devices manufacturing and servicing, pharmaceutical companies, biotech, cosmetics and nutraceuticals.

Training supports strategic growth. Compliance training ensures your medical device, biopharmaceutical and life sciences companies are effectively managing time to market and other strategic goals including the following:

•    Facilitate innovation and drive greater operational efficiency
•    Conserve capital and support acquisitions and divestitures
•    Integrate quality functions into core business processes
•    Manage supply chain planning and optimize distribution
•    Reduce the risk of non-compliance

New Hire Training

Give your employees, vendors and partners a training platform that’s social, easy, fast and fun. Designed for the 2020 workforce today.


Author, deliver and measure training faster, automate certifications and get the reporting you need.

Talent Development

Give your teams the career ladders they desire with mentoring made easy, fast and fun. With game-like training designed to appeal to Millennials and the rest of us.

Socially Oriented

Socially interactive performance rating for individuals by team members.

PHONIZE is a Complete System for Managers to Level Up Leadership, Skill Building, & Training on a Smartphone or Tablet
with Courses from Industry Experts.


Now, it’s easy for you and your company to create and deliver digital training online or as an app to your staff. The built-in authoring tool makes it simple and is 16x faster than traditional systems. Your teams can easily get training anytime, anywhere in a way that is individualized, intelligent, social, fast and fun.


The PHONIZE platform offers three-minute mini training sessions with feedback, and game-like capabilities for an individual to compete with other team members and earn rewards as progress is made. The solution offers managers a quick and easy way to get reporting on an individual’s progress and compare with other staff performance.

Social with Yu-Kai Chou's Gamification Framework

Employing Octalysis gamification framework created by the world’s top enterprise expert, PHONIZE is designed to optimize engagement and social interaction.

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