Insights

27
Apr
2018

How the CMDCA Has Changed the Medical Device Industry and Why Certification Matters

The International Organization for Standardization has been working to update the laws and regulations that govern the manufacturing of medical devices.
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24
Apr
2018

Why Advanced Certifications from CfPIE Make a Difference to Hiring Directors


For professionals in the regulatory fields, certifications like the CMDCA certification are something that can make a big difference on your resume.
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20
Apr
2018

Meet Our Instructor: Judy Carmody, Ph.D., of Analytical Method Validation

With over 25 years of experience in the (bio)pharmaceutical industry, Dr. Judy Carmody has a unique approach to developing solutions for Quality or Analytical issues.
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17
Apr
2018

Course Spotlight: Good Manufacturing Practices Training

This is a three-day course that provides a thorough dive into the foundations of manufacturing and distribution regulations for the medical and pharmaceutical industries in the United States.
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13
Apr
2018

European Regulatory Procedures-EMA & National Requirements

The European Regulatory Procedures course is designed for you
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10
Apr
2018

Are Clinical Trial Wait Times Delaying Drug Discovery?

Just ten years ago, it took an average of six months to get a clinical trial for a new drug off the ground.
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30
Mar
2018

How In Silico Studies Speed Drug Discovery

In vitro and in vivo studies have well-known weaknesses.
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23
Mar
2018

8 Horrifying Medical Devices and Procedures That Existed Prior to the FDA

From testing to documentation, code adherence is part of modern life.
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20
Mar
2018

TABLETS VS CAPSULES — DOES IT REALLY MATTER?

Will your API make it to the target site?
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16
Mar
2018

SOPS — THERE’S MORE TO WRITING THEM THAN YOU THINK

It is estimated that miscommunication costs the healthcare industry 1.7 billion dollars per year.
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13
Mar
2018

OVERVIEW OF AN FDA INSPECTION

As long as you are calm, organized, and informed, you and your team can make it through your inspection.
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06
Mar
2018

5 Ways CfPIE Pharmaceutical Certifications Advance Your Career

CfPIE certification pathways offer many benefits to organizations and individuals.
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05
Feb
2018

Why the Classroom?

Find out why classroom learning is the best choice for pharmaceutical, biotech, and medical device training courses
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04
May
2017

Treatment Option for Hep C in Pediatric Patients - FDA Approval

Can FDA approval of Harvoni provide treatment options for hepatitis C in pediatric patients? Read more to find out the safety and efficacy of Harvoni.
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20
Apr
2017

How Will The Upcoming CE Changes Affect the European Union?

How will the upcoming CE changes affect the European Union and what can we expect? Find out more in this blog post from CfPIE.
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24
Mar
2017

Procalcitonin Assay - Controling Unnecessary Antibiotic Use

Increased antibiotic resistance is becoming an alarming concern. Find out how the Procalcitonin (PCT) Assay can help with antibiotic abuse and why it's FDA approved.
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20
Mar
2017

What the Updates to GMP Facility Inspections Mean for US & EU

The US & the EU have amended the Pharmaceutical Annex to the 1998 Mutual Recognition Agreement. Read more to find out the developmental phases.
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09
Mar
2017

SLCN Could Open Door for Advanced New Diabetes Treatment

Can synthetic lineage-control network be the next step in diabetic regenerative medicine? Can we solve the problem of beta cell regenerative science?
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15
Feb
2017

Amendments to Regulations Governing Medical Devices in the EU

Amendments to regulations governing medical devices in the European Union. What are the proposed changes and what are the implications to manufacturers?
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