Living beings are at the center of the pharmaceutical, biotechnology and medical devices fields, and the U.S. Food and Drug Administration (FDA) and other agencies rigorously regulate these industries. Fines and penalties for noncompliance can amount to billions of dollars when pharma and biotech companies fail to comply with FDA regulations.
Professionals working in pharmaceutical, biotech, clinical trial, and clinical research companies don’t have time to weed through the ever-growing and unclear morass of rules and laws that regulate their fields, so let AudioEducator do it for you with our pharma and biotech audio conferences and webinars.
Our expert speakers cover the most important aspects of regulatory compliance, including the very latest pharma and biotech guidelines from the FDA. We also focus on training solutions in the areas of biotechnology research, clinical development, clinical trials, and drug discovery, development and formulation. Our AudioEducator Blog also features regular posts and updates on the latest compliance issues for pharmaceutical and biotechnology companies.
Compliance with FDA Regulations
The FDA is the main source of regulatory and compliance requirements for the pharma and biotech industries, and it continues to pump out the red tape. Over 5,200 of the agency’s total recalled products in 2016 were from the pharma, device and biologics category – more than double the amount of food product recalls.
Drug, device and technology companies regularly grapple with and need advice on:
Participants in FDA-regulated industries must demonstrate compliance with 21 CFR Part 11, which requires manufacturers of drugs, biologics, biosimilars and medical devices to maintain and prevent unauthorized access to data used for quality control. They must understand the following areas in order to ensure compliance in this important area:
Quality management may be the heart and soul of compliance for pharm and biotech companies. Reducing human error and improving product safety are the most important goals that a quality control or quality assurance system or policy can have. Is your company familiar with the latest developments and best practices relating to these key topics?
Laboratories are one of the most important locations for companies in these industries – and the government wants to know what’s going on in there. Compliance in the laboratory should be high on your list of concerns, which should include:
Medical device risk management under ISO 14971 and pharmaceutical risk management under ICH Q9 are bedrocks of the industry. Because use of medical devices and pharmaceuticals always involves some measure of risk, industry participants are charged with identifying risks and taking reasonable steps to mitigate them.
Issues that industry participants encounter when investigating risk and fulfilling validation requirements for medical devices include:
Good Manufacturing Practices (GMPs)
Pharmaceutical, biologics and medical device industry participants need to accurately understand Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (GMP) requirements.
The FDA recently issued a guidance document that supports a pharmaceutical quality systems (PQS) approach to current GMPs – are you familiar with it, as well as the following key issues in this top compliance hot spot?
Contract Research and Contract Manufacturing
Drug and device companies must carefully select suppliers and contract researchers and manufacturers and are responsible in the end for the quality and safety of the products that others help them research and produce.
Is your company inappropriately delegating this responsibility to its contract manufacturer organizations (CMOs) or contract research organizations (CROs)? Rigorous, formalized procedures are required, as well as familiarity with the rules surrounding:
Import and Export Compliance
Pharma, biotech and medical device companies that import merchandise into the United States are also responsible for compliance with U.S. Customs and Border Protection’s (CBP) laws and regulations relating to:
Why Attend Our Webinars & Audio Conferences?
AudioEducator offers a library of webinars, audio conferences, transcripts and DVDs on all the key topics that pharma and biotech industry professionals need to keep up with. Join the thousands of industry insiders just like you who have already discovered the benefits of our training programs, which include:
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