Insights

19
Feb
2019

Quality System Regulation: Reflecting on CAPA Procedures

Our training program (QSRCP) Quality System Regulation (QSR) Certified Compliance Professional™ is designed to demystify the complex regulatory policies of the FDA for Quality System Regulation, a process with some many moving parts that pharmaceutical and medical device manufacturers find themselves in a maze of stumbling blocks. Non-compliance is costly in terms of time and money, and quality system regulation touches every stage of development.
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12
Feb
2019

Press Release : CfPIE Introduces New Advanced Blockchain Concepts for the Pharmaceutical and Medical Device Industries

The Center for Professional Innovation and Education (CfPIE) is pleased to announce that they will offer a new training program geared towards improving security and data storage for clinical trials and the R&D pipeline. Life Science professionals wishing to prepare in advance of the 2023 FDA Drug Supply Chain Security Act will greatly benefit from attending the Advanced Blockchain Concepts for the Pharmaceutical and Medical Device Industries on May 13-14, 2019.
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05
Feb
2019

The Consequences of Non-Compliance in Computer System Validation

An essential piece of the R&D puzzle, computer systems are not only storage places for data in pharmaceutical development, but have become the sites of quality control, automation, and feedback that aids in decision-making throughout the lifecycle of your business.
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29
Jan
2019

New Directions in Pharmaceutical Development: Preparing for the AI Future

Artificial intelligence is a topic gaining traction across many industries, not least pharmaceutical development. The benefits are obvious: AI can process huge amounts of data, eliminate human error in repetitive tasks and apply checks and balances to systems where our human memory fails. But there are also risks associated with implementing AI studies that need to be explored by qualified pharmaceutical development professionals.
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22
Jan
2019

Evaluating CROs: How to Ensure Good Laboratory Practice Measures are in Place

As of 2017, there were more than 1100 contract research organizations (CROs) operating globally, in an industry expected to grow at a rate of 7.6% between now and 2023. Some of these research organizations are one-lab specialists studying the impact of new pharmaceutical compounds on particular systems or organs, while others are multinationals who strive to be full-service, one-stop shops.
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15
Jan
2019

Good Manufacturing Practices: The FDA’s Year in Review

In December of 2018, the FDA released a report: Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. This communication replaced the 2014 guidelines, and included several updates to protocol. Among these were testing for shelf-life and stability of medications, storage of reserve samples in the lab, and crucially, differentiating between sterile and non-sterile drug compounds in storage and other considerations.
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08
Jan
2019

Biopharmaceutical Courses for the Pharmaceutical Professional

Whether you’ve been in the industry many years or are a new entrant into the field, those in the pharmaceutical industry know that biopharmaceuticals are the wave of the future, and indeed are experiencing steady growth not only in America, but worldwide as well.
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24
Dec
2018

How to Avert Disaster: (CMCCP) Chemistry, Manufacturing & Controls (CMC) Certified Professional™ Chemistry Certification

Just this week, biotech company DBV Technologies learned a harsh lesson in proper CMC protocol, as they were forced to withdraw their approval application of Viaskin Peanut, a peanut allergy treatment targeting children 4-11 years old. The FDA cited chemistry, manufacturing and controls issues as their reason for their rejection of DBV’s biologics license application, causing the company’s stock to drop a staggering 67.4%.
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18
Dec
2018

Choosing the right laboratory information management system (LIMS) for your business

At CfPIE, our instructors aim to address the full scope of concerns pharmaceutical professionals have, from ensuring good manufacturing practices training and guidelines are established, to reducing time-to-market to improve sales and marketing activity.
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11
Dec
2018

Drug Development Training: Keeping Your R&D Operations Compliant

At CfPIE, we understand the necessity for compliance training programs that fit with your team’s schedule and individual needs. Our Drug Development Process from Concept to Market course allows your company to ensure that those directly involved in drug development, like R&D scientists, are communicating effectively with teams in statistical analysis, sales, marketing and the like, to share information and develop a common understanding of the product lifecycle.
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04
Dec
2018

Understanding the Scope of Quality System Regulation

In an era of rapid pharmaceutical and biotechnological change, the FDA has a responsibility to the public to continually monitor and refine its standards of compliance for manufacturers of medical devices, drugs and treatments.
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27
Nov
2018

Process Validation: How to Collect the Right Data for Premarket Validation

Process Validation professionals know that the issue with gaining FDA approval for mass manufacture is not merely collecting data in the premarket phase, but collecting the correct data that truly demonstrates the protocols in place are valid and replicable.
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20
Nov
2018

Chemistry, Manufacturing & Controls (CMC): Regulatory Compliance for Biopharma Professionals

An integral step in the drug development process, Chemistry, Manufacturing & Controls (CMC) is the link that takes a promising compound and makes it a replicable reliable product that can effectively treat patients. For pharmaceutical professionals who concentrate in this area, the rewards can be huge:
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13
Nov
2018

Biopharmaceutical Market Directions: The Next Decade in Plasmapheresis Treatment

As biopharmaceutical manufacturers move to increase their supply of all types of biotechnology products in the face of consistent domestic demand and growing offshore markets, one treatment is emerging as a global leader with significant growth potential.
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06
Nov
2018

Modern Pharmaceutical Development Protocols: Is Your Company Ready for the Future?

On October 15, 2018, FDA Commissioner Scott Gottlieb issued a statement about new regulatory frameworks in development for researchers and manufacturers who work in cell and gene therapies, targeted therapies and other new pharmaceutical development streams that do not as yet have a clear pathway or regulatory outline approved by the FDA.
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23
Oct
2018

FDA Submissions: Make the Application Process Work for You

If you are a pharmaceutical professional who works directly with the FDA, you understand the importance of effective communication tailored to your audience. The FDA’s responsibility to the public necessitates rigorous submission guidelines that can often be confusing, even to the experienced professional.
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16
Oct
2018

The R&D Pipeline: Pharmaceutical Development Certified Professional™

At the top of the pharmaceutical funnel, research and development of new drugs and treatments is a crucial process that can have huge costs to a business, both in time and money. The timeline for a new pharmaceutical development can take as much as 15 years for a drug or vaccine
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09
Oct
2018

Good Laboratory Practices - Certification Designed to Advance Your Career

Good Laboratory Practices certification is designed for compliance professionals, a high-demand career path that is both rewarding and a site of constant innovation. Good Laboratory Practices are essential for pharmaceutical companies to operate efficiently, ethically, and cost-effectively. Well beyond the operating safety standards for laboratories,
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02
Oct
2018

GMP Certification Courses Tailored to Your Needs

Good Manufacturing Processes (GMP) certification is an essential component of the manufacturing process, protecting you, your partner labs, and your reputation and standing as a manufacturer of quality pharmaceuticals.
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