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Webinars

Where FDA Is Heading in Regulating Laboratory-Developed Tests

Where FDA Is Heading in Regulating Laboratory-Developed Tests

The webinar will cover the federal regulatory approach to regulating laboratory-developed tests including the role of CLIA, the rationale for and opposition to direct FDA oversight, the goal of possible federal legislation and the prospects for future action by the FDA and/or Congress.
Raw Materials in Pharma/Biotech Production

Raw Materials in Pharma/Biotech Production

In the webinar, gain the skills for practical implementation of regulatory requirements for Pharma/Biotech raw material selection, receipt, testing, storage, and use in production.
Practicing Laboratory Safety in the Workplace

Practicing Laboratory Safety in the Workplace

In this training program, attendees will gain an understanding of general laboratory safety and common lab operation procedures. The course will also instruct on what PPE to provide such as safety goggles, aprons, gloves, eyewash stations, fire extinguishers, first aid kits, etc.
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.
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.
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.
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.
Effective Time Management in Clinical Trials

Effective Time Management in Clinical Trials

Attend this webinar to learn how to shorten the timeline for key deliverables such as case report form Design, database build, and duration between last patient out and database lock without negatively impacting data quality or putting data integrity at risk.It will cover useful tips and guidance about the activities that may be streamlined without reducing quality and budget considerations. The webinar will cover warnings about quality steps that should not be eliminated or short-changed in a rush to get done faster.
Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers

Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers

This webinar will provide you the information you need to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet expectations of the FDA and ISO 13485 Notified Body auditors.
EU ISO 13485:2016 Medical Device Quality Management System

EU ISO 13485:2016 Medical Device Quality Management System

Learn the basic overview of the international medical device Quality Management System -- EU’s Quality Management System under ISO 13485:2016. Implementation, training requirements, content and annual internal audit / inspection expectations.
Estimating Reliability Performance with Accelerated Life Tests

Estimating Reliability Performance with Accelerated Life Tests

This webinar on Estimating Reliability Performance of products will show how you can use Accelerated Life Testing methods (ALT) to reduce costs, minimize risks and ensure adequate product performance prior to launch.
Regulatory Inspections - How to prepare for a visit from an FDA Auditor

Regulatory Inspections - How to prepare for a visit from an FDA Auditor

In this webinar, learn the purpose of FDA audits and scope, the QSIT audits, and how to be prepared for an audit. You will also learn how to communicate with FDA prior to and post the audit.
Technical Writing in an Industrial Environment

Technical Writing in an Industrial Environment

This training will teach you the logical, fast, and simple process of writing any document your company needs easily. You will learn how to organize compiled information, write the document, and address the comments of reviewers and approvers.
Biocompatibility Testing; what you need to know

Biocompatibility Testing; what you need to know

Attend this webinar to learn how to use ISO 10993-1 and FDA standards to establish a biological safety evaluation plan, how to implement the plan, how to assess your device for biological risks and when testing is not required.
Management of the Data Safety Management Committee for Clinical Trials

Management of the Data Safety Management Committee for Clinical Trials

Join this webinar to receive instructions on the uses of, need for, setup of, and management of a Data Safety Management Committee for an FDA regulated clinical trial.
HIPAA Planning for 2020 and Beyond - Protecting Patient Information Privacy and Security

HIPAA Planning for 2020 and Beyond - Protecting Patient Information Privacy and Security

Bad news: Patient information privacy and security are one of the biggest issues facing healthcare organizations.
Good news: Your organization can withstand incidents, audits and investigations by HHS by ensuring compliance with HIPAA.

In this webinar, you will learn how to prepare for a year of HIPAA work including responding to issues and planning for regular compliance activities.

2019 New Privacy Officer Training - Module 2

2019 New Privacy Officer Training - Module 2

HIPAA Privacy Officer Training will provide a comprehensive overview of all ongoing activities of a Privacy Program related to the development, implementation, maintenance of, and adherence to the organization’s policies and procedures covering the privacy of, and access to, patient health information in compliance with federal and state laws and the healthcare organization’s information privacy practices.
Avoid Documentation 'Time Bombs'

Avoid Documentation 'Time Bombs'

This documentation training will explain regulatory ramification of communication done through Lab books, SOPs, DHF, technical files etc and how to reduce it.
C-TPAT Compliance for FDA-Regulated Industries

C-TPAT Compliance for FDA-Regulated Industries

Attend this webinar to get an overview of the Customs and Trade Partnership Against Terrorism including “Tiered” strategy, guidelines, highlights, and compliance. We will also cover the major areas needed to build a successful framework that will support your compliance program including policies, SOPs, documentation, and training.
What to Expect from FDA's Approach to Regulate Medical Software

What to Expect from FDA's Approach to Regulate Medical Software

The FDA’s emerging approach to medical software product regulation has important ramifications for patients, healthcare providers and insurers as well as product developers. So, it is critically important for companies throughout the life sciences and healthcare industries that utilize software in its products to understand the important challenges and opportunities presented by this major policy shift. This webinar will provide understanding.
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