Compliance Training Webinars for Regulated Industries

This FDA compliance webinar will help the attendees develop an effective training program and training plans for an organization. Attendees will learn GxP training requirements in US and EU.

This webinar on verification vs. validation will help you to understand the differences between, and benefits of, verification and validation in both design and process operations in regulated industries. Learn about the risks and complications involved with the application of sound verification and validation principles.

This training program will offer insight into where extractables and leachables come from. Attendees will learn the regulatory expectations and trends for extractables and leachables in early phase development and learn which products may require E&L data in early phases. The program will also focus on how to design programs to meet the needs of early phase development – i.e. phase appropriate E&L programs.

This Post-market Surveillance (PMS) webinar will discuss in detail the clinical evaluation and risk management requirements as described in MedDev 2.7/1 Rev. 4, EN ISO 14971:2012 and EN ISO 14971:2012 standards and how they are related. It will also explain some of the recent changes in EU medical device regulations.

The webinar will focus on the path most health care organizations in the country have taken to integrate along with the internal fragmentation that often remains after the deals are over. It will also discuss emerging best practices to manage fragmentation and risk.

Risk matrices are used during risk assessment to define the various levels of risk as the product of the probability and impact categories. This webinar training will focus on this simple but powerful mechanism to increase visibility of risks and assist management decision making. Risk matrices are one of the most widespread tools for risk evaluation.

This webinar will provide an overview of SEC Whistleblower Rules such as False Claims Act, Dodd-Frank, Sarbanes-Oxley and Commodity Exchange Act. It will also discuss best practices on how to mitigate damages from an actual or purported whistleblower.

This webinar will cover background information and history of clinical research and drug development, followed by review of the federal regulations, International Council for Harmonisation (ICH), and Good Clinical Practices (GCP) that apply to clinical research.

This medical device training program will provide an understanding of creative methodologies to solve design and development challenges of connected solutions for patient monitoring, scheduling, tracking, or drug delivery. It will demonstrate how consumer technologies vary by level of complexity and how they can be used in healthcare.

This training will discuss the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016. Attendees will learn how to establish a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the FDA.

This training program will discuss the requirements of ICH and the FDA for stability protocol content and format, including special stability studies required for approval.

This training program will discuss optimizing your packaging design for commercial and clinical products and translating a protocol into effective packaging design. Attendees will learn how to implement an effective artwork change management system. Real-life case studies and dos/don’ts for packaging and labeling for commercial and clinical products will also be discussed.

This training program will guide attendees in implementing QbD principles from discovery through product discontinuation. It will also illustrate applying statistics to set specifications and validate measurement systems (assays) and discuss utilizing risk management tools to identify and prioritize potential critical process parameters.

This training program will analyze the factors and causes behind human errors. It will define the process to manage human error deviations and participants will learn about human error measurement. The program will also discuss tools for measurement and Key Performance Indicators (KPIs).

This training program will help attendees grasp the essentials of project management and plan effectively for identifying project needs. It will also discuss practices for keeping content, process, and structure on track to produce positive outcomes.

This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.

This webinar will present a Lifecycle Risk Management System that meets FDA and ISO requirements. That risk management system (based on ISO 14971) creates a closed loop system that identifies risks, and uses field use feedback to adjust risks and to improve designs and processes. The objective evidence produced by a Lifecycle Risk Management Systems can be used to demonstrate risk management compliance to 21 CFR Part 820 and ISO 13485.

This webinar will discuss the FDA requirements for pharmacovigilance and complaint evaluation under GMP

This Webinar will present the best practices for integrating medical device risk analysis into a quality system. This integrated processes spans new product development, design change, production, and post market surveillance for the lifecycle of the device. Objective evidence produced by the integrated processes can be used to demonstrate risk analysis compliance to 21 CFR 820 and ISO 14971 during an audit.

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.