Insights

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.
Continue Reading ?
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.
Continue Reading ?
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.
Continue Reading ?
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:
Continue Reading ?
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.
Continue Reading ?
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.
Continue Reading ?
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.
Continue Reading ?
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
Continue Reading ?
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,
Continue Reading ?
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.
Continue Reading ?
25
Sep
2018

Identifying Process Validation Issues

n advance of our completely-updated course Process Validation for Drugs and Biologics, we have asked all participants to prepare examples of FDA process validation concerns and issues they have in their own companies for discussion in the session.
Continue Reading ?
17
Sep
2018

Regulatory Compliance for CMC Biologics - How Good Manufacturing Practices Can Help You

The continual change of the Chemistry, Manufacturing & Controls landscape is familiar to anyone in the biopharmaceutical industry, but the headache of compliance is one that CfPIE is determined to solve for biologics producers in the United States.
Continue Reading ?
11
Sep
2018

International Compliance Training -- Expanding Your Business Overseas

Clinical compliance is a key activity in the management of laboratories, not only to ensure the validity of any trials conducted, but also the health and safety of employees in the lab.
Continue Reading ?
04
Sep
2018

Selecting and Managing CROs in Emerging Markets: How to Prepare Your Company for Global Growth in the Biopharmaceutical Space

Is your company preparing for international expansion? Whether you’re in the middle of a 10-year plan or just beginning to tackle the mountain of regulatory information required for bioprocessing operations in a new country, the Selecting and Managing CROs course is an excellent step to take that will set you on the path to success.
Continue Reading ?
29
Aug
2018

Course Spotlight: Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management

Stay up to date on contamination control in modern cleanrooms with technical training courses from CfPIE. Our Cleanroom Fundamentals course, led by CfPIE instructor Wen Schroeder, is one of many industry training courses available.
Continue Reading ?
23
Aug
2018

Onsite Training Courses Feature Your Own Data and Examples

Use CfPIE’s custom onsite training programs to help your employees work better within your organization - here’s why it works.
Continue Reading ?
21
Aug
2018

Understanding Industry Certification: Why It's Relevant and Necessary

Find out why it’s important to complete industry certification programs after you’ve been hired – and why you need them in the first place.
Continue Reading ?
15
Aug
2018

Instructor Spotlight: Wen Schroeder

Meet Wen Schroeder, CfPIE’s expert instructor in skin care and cosmetics industry training courses.
Continue Reading ?
09
Aug
2018

Medical Device Certification Programs Keep Employees Up-to-Date with Industry Technology

Keep your employees certified in the latest medical technology through CfPIE’s medical device certification programs. Here’s why it matters.
Continue Reading ?