Compliance Training Webinars for Regulated Industries

This 90-minute training will discuss the FDA's QSR requirements for a Device Master Record (DMR) and how you can use it to build your Device History Record (DHR). You will learn what to keep in each record and organize them to help you lower cost in the QMS and provide valuable information when you need to investigate a problem and take corrective action.

This clinical documentation webinar will discuss how to appropriately document in the history, physical exams, and assessment and plan section of the EMR. It will also provide practical tips on designing templates, as well as avoiding common audit pitfalls.

FSMA has modified the traditional position that FDA would not collect fees from food companies to allow collection of the agency’s costs of remedying certain violations of food law. This training program will offer a background on FDA imposition of fees on food producers, the fee amount, and how it applies to small businesses.

This training program will offer an understanding of analytical method life cycle and regulatory expectations and requirements for the methods during product development. The webinar will also analyze risks and inherent variability of analytical methods.

In this training program, attendees will explore modern technologies, process changes and smart architectural design that can extend the useful life of manufacturers' aseptic and biologic facilities by 10 to 20 years. These upgrades can also make facilities more compliant, cut down on operating risks, and improve performance.

Health care organizations should be monitoring and auditing their existing call coverage arrangements to ensure they are compliant with regulatory requirements in case they are challenged. This training session will provide an overview of the Anti-Kickback and Stark Law, including 2016 changes and updates.

This GMP inspections webinar will review what to expect during the agency inspection and how to successfully and efficiently streamline and manage the inspection, including adequate follow-up during and after the inspection.

This webinar will help you gain a greater understanding of regulatory and compliance requirements and how the early product lifecycle requirements establish the basic groundwork as a foundation from product development to commercialization continuing to out commercialization and product discontinuation.

This training program will highlight all the key areas that need to be under control or can lead to product recalls, product liability lawsuits, and the causes of these economic disasters for manufacturing corporations.

This training program will help attendees identify the differences in Excel 2016 from previous versions. Attendees will also learn which worksheet functions are available in Excel 2016 but not in other earlier versions of Excel. Understand the nuance involved between the 32-bit and 64-bit versions of Excel.

This training program will explore how using service level agreements along with key performance properly will enable a shipper to drive continuous improvement in their supply chain. SLAs and KPIs will also ensure that agreed to, objective measurements are being used to judge 3PL performance. An SLA along with the proper KPIs will allow shippers to create incentives, disincentives and exit clauses based on performance.

In this webinar, attendees will learn how lyophilization cycles are developed, how lyophilizers work and how they are controlled and what is important to FDA and other regulatory bodies in the inspection of lyophilizers and in the validation process.

The new ISO 9001:2015 requires companies to establish context of the organization and utilize this perspective along with the new High Level Structure (HLS) Clauses. This webinar is designed for quality assurance managers, management representatives, ISO 9001 implementation teams, and quality management system auditors. With the release of ISO 9001:2015 in September 23, 2015, now is the time to prepare. This 9001-2015 Transition Overview course will highlight the changes from the ISO 9001:2008 revision.

This training program will analyze ADV Part 1, ADV Part 2 A, ADV Part 2 B, and offer a breakdown of each section of the ADV. It will discuss annual filing requirements and offer best practices for reporting accurately.

The training program will provide insight into complying with the key QMS requirements for organizations selling medical devices in Canada.

This OSHA Recordkeeping training will address the concepts that are most frequently misunderstood and that lead to errors in OSHA recordkeeping.

This clinical research training will explain the Institutional Review Board (IRB) models. It will discuss the regulatory framework for IRB review including 21 CFR 50, 56 and 45 CFR 46.

This training program will identify regulations and guidelines pertaining to data management in clinical research. Attendees will learn to translate the regulations and guidelines into practical application for each stage of the clinical trial: start-up, ongoing study management, and study closure. The program will also discuss the do’s/don’t for data management activities through real-life examples.

This training program will explain what the critical areas and elements of vendor oversight are and how you can set such a system up for yourself at your company.

In this training program, attendees will learn how to gain access to the financial regulators priorities and understand how to apply those priorities to their firm. The program will also discuss incorporating the priorities into your annual review and identifying priorities that need to become part of the compliance manual/code of ethics.