Compliance Training Webinars for Regulated Industries

In this webinar, ISO certified lead auditor for 27001, Ed Moyle, and Diana Kelley, Partner at Security Curve, will explain how organizations can use the ISO standards as a baseline for their security and risk management program. This webinar will provide valuable assistance to all companies are building and maintaining information security management systems.

The presentation will use examples taken from warning letters to illustrate some of these problems, and discuss possible solutions. As an example, we will discuss the process for accepting raw material.

In this webinar we will cover the legal principles developed by the common law concerning employee privacy, the major anti-discrimination laws.

This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. All Clinical Research protocols have a prominent safety monitoring plan as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.

This program will cover the remaining regulations excluding the QSR which was covered in Part 1. This webinar is especially helpful for new startup companies that are entering the medical device field for the first time.

Emphasis is placed on conducting effective process auditing through an internal audit program within a company’s quality management system. This webinar is intended to review the requirements for determining if a company has its processes under control, with reviews of the requirements and description of the methods to determine which processes are expected to be audited.

This program is specially designed for personnel in the Pharmaceutical and Biotechnology industries. This guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.

While simple to describe many companies fall into the trap of territoriality, and confusion of roles and responsibilities. This webinar will walk through the elements of a process validation program for biological products with an emphasis on the involvement of all functions especially process development.

ComplianceOnline brings you a pack of 2 courses covering two of the major compliance areas faced by Clinical Laboratories.

This presentation will discuss the quality-related activities that are expected for different stages of the product development process. Emphasis will be placed on the transition into full GMP work as clinical trials proceed, but the requirements for DMFs and NDAs (or BLAs) will be discussed.

How do you create and blend the Risk Management File findings into your annual audit plan? How is it established, maintained, formally updated, and documented? Structured, defined and scheduled internal CGMP compliance audits are a specific requirement of US FDA 21 CFR 820 and ISO 13485 (devices), implied in 21 CFR 210, 211 (pharma)

This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device as well as track post market risks. Participants in this webinar will learn about techniques that will be useful in analysis of post market human factors design problems and in preventing these problems through pro-active use of post-market surveillance techniques and customer support data.

Learn the appropriate and expected regulatory strategies and guidelines for your IDE. This webinar will provide valuable assistance and guidance to medical device firms that are currently preparing or will prepare for IDE submissions.

Regulatory expectations for reporting in multi-company development and marketing programs.

This presentation will cover sections 4 and 5. These contain the requirements for accreditation. ISO 17025 “describes” the elements of a good management system for a laboratory. It also details the principles for a laboratory to ensure technical competence.

This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485. This webinar reviews the requirements of ISO 13485 in a straightforward manner, and includes suggestions for development of a compliant system.

The process mapping tool is presented to the participants in a clear and effective manner complemented by an array of relevant examples. This webinar will be valuable for any member of any industry desiring process improvements.

The presentation covers the requirements of the Code of Federal Regulations for drugs, biologics, and medical devices, as well as key FDA Guidance Documents including the International Conference on Harmonization (ICH) E6. This program is essential for management of clinical trial sponsors and vendors.

This webinar will cover the concepts of critical cleaning, FDA requirements and cleaning validation. This webinar will enable one to approach issues surrounding cleaning validation.

This presentation will cover the regulations that apply to biologics in general as well as those that apply to members of the special classes. This webinar will be directed at workers with some experience who must now deal with the manufacturing of various biological products.