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Feds Take New Aim at Prescription Drug Prices: What to Expect from the Biden Administration & Congress
Dennis Weissman
60 Min
Product Id: 706759
Responding to the public’s ongoing concern about high and rising drug prices, the Biden Administration and 117th Congress with a fragile Democratic majority have unveiled key proposals to lower prescription drug costs.
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Biosimilars in Europe: Pricing, Interchangeability and Policy
Peter Wittner
90 Min
Product Id: 706760
As far as biosimilars are concerned, Europe led the way and the rest of the world, including the US, followed - but how did this happen? The webinar will explain how Europe’s EMA developed the first regulatory environment that allowed multiple competitors to enter the market and start to take market share away from the originators. It also looks at the effect of the increased competition, the moves to include biosimilars in tenders, the resultant impact on prices, how the originators fought back and where we are now.
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Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats
Michael Esposito
90 Min
Product Id: 706067
Counterfeit drugs present a real and increasing danger both to patients and companies and require a proactive approach to stay ahead of them. This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.
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Quality Assurance and Good Manufacturing Practices (GMP) in Drug Production
Charles H Paul
90 Min
Product Id: 706936
Quality Assurance (QA) and Good Manufacturing Practices (GMP) play a critical role in ensuring the safety, efficacy, and quality of drugs during their production. In the pharmaceutical industry, QA refers to the systematic processes and procedures implemented to guarantee that drugs meet the established standards and regulatory requirements. GMP, on the other hand, encompasses a set of guidelines and regulations that govern the manufacturing, testing, and quality control of pharmaceutical products.
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FDA Compliant Marketing/Promotions for Medical Device Companies - Best Selling Package Webinar
5 Hrs
Product Id: 701832
The following is a pack of 4 best-selling training CDs for sales, marketing & regulatory professionals in the Medical Device industry. These courses provide solutions for all critical challenges & questions faced by you and your team pertaining to regulations/compliance, best practices, etc.
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The GCPs: How to Implement for Compliant Clinical Trials
John E Lincoln
90 Min
Product Id: 706935
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible.
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Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
Frank Stein
3 Hrs
Product Id: 706565
This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to conduct an internal audit with MDSAP requirements to check, if your quality management system meet all MDSAP requirements.
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Understanding FDA and Health Canada
Ricki Chase
90 Min
Product Id: 706933
This webinar will provide an overview of FDA and Health Canada, their organizational structure, regulatory and compliance oversight, agency interactions and implications for your organization and your regulatory and compliance obligations.
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Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137
Mark Dott
60 Min
Product Id: 701255
This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.
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GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)
Carolyn Troiano
90 Min
Product Id: 706932
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
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Technical Writing - Medical Devices - Writing Effective 510K, PMA, and De Novo Submissions
Charles H Paul
180 Min
Product Id: 706931
In a rapidly evolving medical landscape, the significance of meticulous and effective technical writing cannot be overstated. Join us for a enlightening 3-hour webinar, "Technical Writing for Medical Devices: Writing Effective 510(k), PMA, and De Novo Submissions," where we will delve into the intricacies of crafting comprehensive and persuasive regulatory submissions. From the foundational understanding of regulatory pathways to the fine art of presenting clinical data, this webinar will equip you with the tools and knowledge necessary to excel in this critical aspect of the medical device industry.
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Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections
Glen Feye
63 Mins
Product Id: 700375
This SOP best practices webinar will show how to create “state of the art” SOP or review your current SOP so as to successfully manage FDA Investigators and other Regulatory Authorities Audits which can help improve and influence Audit Outcomes.
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Critical Role of Quality Audit in GxP Compliance & Improvement
David Dills
62 Min
Product Id: 700982
This Webinar will address the key elements on being an effective auditor for your company covering the different types of audits, what do audits measure and how are audit results measured and certainly why perform audits to begin with. Learn the basic skills required and how to apply them and the knowledge in becoming more effective.
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Managing Corporate Risks with ISO 31000
Kelly Eisenhardt
60 Min
Product Id: 705083
ISO 31000 is a standard developed by the International Organization for Standardization (ISO) which provides a basic guideline and principles for the application of risk management. Companies that use risk management processes vary across industries in scope and magnitude and address a wide variety of challenges. This training program will offer an in depth look into the key components of the ISO 31000 guideline and best practices to implement and support a corporate risk management strategy or program.
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How to Manage a Medical Device Recall Efficiently and Effectively
David Dills
64 min
Product Id: 700911
This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement. Attend this webinar to know what happens in a recall and what are the strategies and operational procedures in a recall.
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Zero-Injury Workplace Culture vs. Safety Culture
Joe Keenan
60 Min
Product Id: 704986
Creating a safety culture in the workplace takes time, patience, and is often a multi-year process. This training program will examine how organizations need to transition from the existing zero injury workplace culture to a more safety oriented culture. In the process, it will examine the pros and cons behind each process and also offer best practices to determine whether you are doing it right.
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Medical Devices Periodic Safety Update Report (PSUR)
John E Lincoln
90 Min
Product Id: 706880
PSURs are pharmacovigilance and device adverse events documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorization in the EU. The purpose is to harmonize and strengthen benefit-risk review of medical products across the European Economic Area.
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Power BI - DAX Essentials: Unlock the Secrets of Effective Data Analysis!
Mike Thomas
60 Min
Product Id: 706974
In today's data-driven world, having a strong command of Power BI is essential, and understanding the Data Analysis Expressions (DAX) formula language is the key to unlocking the true potential of Power BI’s reporting capabilities.
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Wage Payment Irregularities/ Dealing with Disruptions in the Payroll Process
Patrick A Haggerty
90 Min
Product Id: 706901
This webinar provides overview of common problems encountered in payroll and methods for prevention, mitigation and resolution. The discussion will include when use of specific forms may be required, such as Form 941-X, Adjusted Employer's Quarterly Federal Tax Return or Claim for Refund and Form W-2C, Corrected Wage and Tax Statement. Special procedures related to fringe benefit withholding, deceased employee wages and misclassified employees will be covered.
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Understanding the new International and FDA accepted Software Development Standard IEC 62304
Dennis Moore
60 Min
Product Id: 700318
This training on Software Development Standard IEC 62304 will provide you key insights on how to understand IEC 62304, and how to use the standard to help you uncover software related GMP violations.