Pharma & Biotech

Training Conferences for Pharma & Biotech Professionals

Live Audio Conferences by Industry Experts

Date
Conference
Speaker
Price
 
There is no schedule available under this section. Please check out on-demand or pre-recorded events sections.
There is no on-demand conference available. You can choose events from pre-recorded section and request for replay.
Sep 19, 2017
Carolyn Troiano
$227.00
USA USA
227.00
Sep 15, 2017
Angela Bazigos ..
$227.00
USA USA
227.00
Sep 13, 2017
Danielle DeLucy
$227.00
USA USA
227.00
Sep 12, 2017
Casper E. Uldriks..
$227.00
USA USA
227.00
Aug 30, 2017
Edwin Waldbusser..
$227.00
USA USA
227.00
Aug 10, 2017
Ginette Collazo
$227.00
USA USA
227.00
USA USA
227.00
USA USA
227.00
Jul 20, 2017
Dr. Jerry Lanese..
$227.00
USA USA
227.00
USA USA
227.00
USA USA
227.00
Jun 27, 2017
Casper E. Uldriks..
$227.00
USA USA
227.00
Jun 13, 2017
Angela Bazigos ..
$227.00
USA USA
227.00
Jun 13, 2017
Dr David Carlander..
$199.00
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Practical Training for Professionals Working In the Pharmaceutical, Medical Device and Biotechnology Industries

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:

  • FDA regulations, including FDA 21 CFR Part 11 and 21 CFR compliance
  • FDA inspections, add-on inspections and surveillance inspections
  • FDA quality metrics
  • FDA enforcement and assessment, and FDA citations
  • CFR compliance guidelines
  • FDA data standards
  • The FDA’s electronic submission requirements
  • FDA drug approval process
  • FDA regulatory authority


Validation


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:

  • Process validation
  • Computer system validation
  • Bioanalytical method validation
  • GMP regulatory requirements
  • Test method validation
  • ICH Q8, ICH Q9 and ICH Q10
  • Pharmaceutical quality systems
  • Quality risk management
  • Process design and qualification
  • Continued process verification
  • Test method validation
  • Procedure performance verification
  • Lifecycle management
  • Procedure performance qualification


Quality Management


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?

  • Pharmaceutical quality system
  • Corrective and preventive action (CAPA)
  • Quality risk management
  • Risk management tools and methods
  • Risk ranking
  • Good Manufacturing Practice (GMP) regulations
  • Quality management systems (QMS)


Laboratory Compliance


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:

  • Laboratory controls
  • Training in the laboratory
  • Laboratory stability programs
  • Quality control testing
  • Stability testing
  • Test methods, sampling and special testing
  • Pharmaceutical risk management
  • Laboratory investigations
  • FDA, ICH and USP requirements
  • Laboratory records
  • Laboratory accreditation


Medical Devices


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:

  • Medical device recalls
  • Hazard analysis
  • Fault tree analysis
  • Medical device regulations
  • Medical device regulatory requirements
  • Premarket notification
  • Medical device classification
  • Updates to ISO 14971
  • Predictive modeling
  • CE marking process
  • ISO certification


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?

  • ICH Q8, ICH Q9 and ICH Q10
  • GMP interpretations and requirements
  • GMP facility inspection
  • Quality GMP standards
  • International GMP testing standards
  • GMP testing methods
  • FDA and EU GMP guidance


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:

  • CRO compliance
  • CMO compliance
  • CMO management principles
  • Approved vendor lists (AVLs)
  • CRO audits
  • CMO audits
  • CMO supplier quality agreements
  • Contract drug manufacturers


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:

  • Tariff classifications
  • Customs valuation
  • Free trade agreements
  • Customs and international trade law
  • Intellectual property rights


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:

  • Save time & money on travel: Learn while sitting in your office, conference room or home. No need to travel to distant locations. You can listen to the experts live and participate in Q&A sessions to clear up any lingering questions.
  • Convenient Learning Formats: Choose to attend our webinars, request replays for the webinars already done, or buy DVD recordings and PDF transcripts.
  • Industry Experts: We have a panel of nationally renowned speakers and experts in the pharmaceutical and biotechnology industries ready to train you.
  • Robust Platform: We use a state-of-the art platform for our webinars and audio conferences so that it is a rewarding learning experience for you.