Webinars

Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU

Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU

This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
Technical Writing in the Pharmaceutical Industry

Technical Writing in the Pharmaceutical Industry

In this webinar, learn how to write technical documents in a highly specialized, highly regulated field like the pharmaceutical industry. It will teach you the techniques that that are easy to understand and help in creating high quality documents with the least amount of problems.
The Brazilian Pharmacovigilance System

The Brazilian Pharmacovigilance System

Attend this webinar to learn about the Brazilian pharmacovigilance regulation, risk management, the Health Brazilian Constitution Rights. Learn about labeling, safety reports, harmonization process, benefit-risk legal concept, reciprocity, and more.
Establishing a Robust Supplier Management Program

Establishing a Robust Supplier Management Program

This course will review regulatory guidance governing Suppliers and the elements of a robust supplier management program including, initial qualification, supplier performance monitoring, and scorecards, supplier audit options, and quality agreement requirements. It will discuss how to utilize risk-based quality tools to determine supplier classification with a risk assessment example. Recent FDA audit findings will also be reviewed.
Managing Non-conforming Material and Failure Investigations

Managing Non-conforming Material and Failure Investigations

Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You’ll learn how to identify, segregate, control, and disposition non-conforming material. You’ll learn about when and how to conduct failure investigations and requirements for correction and corrective action.
US FDA Medical Device QSR, 21 CFR 820 and Quality Management System

US FDA Medical Device QSR, 21 CFR 820 and Quality Management System

Learn the basic overview of the original medical device Quality Management System -- The US FDA’s CGMP, Quality System Regulation (QSR) under 21 CFR 820. Implementation, training requirements and content, and annual internal audit / inspection expectations. The FDA’s four key areas of compliance under QSIT.
A Primer on Acute Care Reimbursement: From DRGs to Bundled Payments

A Primer on Acute Care Reimbursement: From DRGs to Bundled Payments

This webinar will help understand DRG system used as the structure for reimbursement under Medicare/Medicaid programs including review of DRG relative weights, case mix index, length of stay, medical record coding, managed care contracting, bundled payments and strategies to control cost and length of stay in bundled payment environment.
OTC Drug Regulations

OTC Drug Regulations

This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.
Good Documentation Guideline (Chapter <1029> USP)

Good Documentation Guideline (Chapter <1029> USP)

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines?

Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines?

This webinar will provide an in-depth understanding of anti-kickback regulations and Stark laws, and discuss how marketing activities can trigger either or both.
Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
Cell-Based Assays in a GMP Environment: Approaches for Clinical and Commercial Stability Studies

Cell-Based Assays in a GMP Environment: Approaches for Clinical and Commercial Stability Studies

This 1-hr virtual seminar will teach how to integrate cell-based assays into your GMP processes to ensure success of GMP-mandated stability studies. You will learn critical information about GMP requirements, how to validate bioanalytical methods, how to use cell based assays for clinical work and commercial work.
How to Develop, Implement and Manage an Effective Change Control Program

How to Develop, Implement and Manage an Effective Change Control Program

Attend this webinar to get a perspective into the regulatory requirements of the FDA, EU, and ICH about the components of a change control program.
EU IVDR 2017/746 - the new EU regulation for invitro diagnostic

EU IVDR 2017/746 - the new EU regulation for invitro diagnostic

Attend this webinar to understand the new requirements of the medical devices regulation EU IVDR 2017/746 in the European Union and get ready to receive the new certificates until May 2022.
The Mindset of an FDA Employee

The Mindset of an FDA Employee

If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. It is important to interact with the FDA employee in the most productive manner. But there is a variable you must deal with that will determine how productive your interaction is. The variable is the FDA employee. That is the purpose of this webinar.
How to write SOP's that Avoid Human Error

How to write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
How Medicare's Market-Based Payment System Is Upending the U.S. Clinical Laboratory Market

How Medicare's Market-Based Payment System Is Upending the U.S. Clinical Laboratory Market

This online training will cover PAMA mandates, CMS regulatory requirements, guidance and related government reports on implementing Medicare market-based Payment Methodology for laboratory services.
Quality Assurance for Continuous Manufacturing of Small Molecule, Oral Dosage Products

Quality Assurance for Continuous Manufacturing of Small Molecule, Oral Dosage Products

The expectations for quality remain the same for batches produced continually vs. bath-to-batch. However, the quality unit must transition to a very different control strategy to ensure product quality. This webinar will discuss quality and compliance considerations for continuous manufacturing as per the FDA draft Guidance for Industry (Quality Considerations for Continuous Manufacturing, February 2019) and with input from other FDA Guidances and ICH documents. The content is intended for small molecule solid oral drug products, but concepts can be applied to other products.
How To Implement An Effective Human Error Reduction Program

How To Implement An Effective Human Error Reduction Program

Attend this training to learn how to implement a Human Error Reduction Program at your site. It includes practical tools and explains how to measure effectiveness to continuously improve human reliability at your site.
CMS Two Midnight Rule

CMS Two Midnight Rule

Attend this webinar to learn the CMS new regulation "the two midnight rule" and what are the medical and financial outcomes of the rule and how to apply the rule correctly to remain CMS compliant and the Controversial of the rule.

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