Compliance Training Webinars for Regulated Industries

Both the U.S. FDA and EU's MDR expect documented risk-based clean room manufacturing environment per ISO 14644-series, ISO 14698-series (and the old FED-STD 209E).

This training program will elaborate factors affecting the target weight decision and help determine the tolerable risks of under-filling and the costs of over-filling. Attendees will gain an understanding of process stability and process capability concepts and methods for process optimization.

The US FDA/CDRH is proposing to harmonize the current Quality System Regulation (QSR) for medical devices (21 CFR 820) by converging its requirements with requirements used by many other regulatory authorities. ISO 13485, into a new device Quality Management System Regulation (QMSR).

Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information, and is a rapidly growing problem for industry. 

In this program, we will discuss the common statistics tools and techniques used in validation. Through real world examples and interactive exercises, we will demonstrate the basic concepts of statistics and how to apply them to your validation projects. Discussion will center around measures of variance, sample distributions, and expressions of variance. The session will conclude with a discussion of the concept of process capability and using process capability to set acceptance criteria for validation.

Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration. Does your DHF remediation process resemble the very mess that it is trying to resolve?
The Design History File (DHF) is the objective evidence that a medical device was designed per design control guidance and applicable regulations and standards. While it is retrospective in nature, it is the end result of a process that begins with planning and ends with Design Transfer and has the Device Master Record (DMR) as a deliverable.

This webinar will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.

This webinar presents an overview of essential quantitative methods for assessing and ensuring product quality. The methods include: Statistical Process Control, Process Capability Assessment, Regression Modeling, Design of Experiments, Hypothesis Testing, and Measurement Systems Assessment.

For years the IRS has struggled with the independent contractor and tax collection. In assessing opportunities to close the tax gap (taxes due but not reported or paid), one of the greatest opportunities comes from expanding the information reporting on taxpayers by payors – the 1099. This time-consuming reporting obligation can be streamlined in a number of ways. Join us to learn more…

ISO 14971:2019 has introduced significant changes including benefit, reasonably foreseeable misuse and state of the art, as well as the management of risks associated with medical devices. It is important to be aware of these changes as technology continues to emerge.

This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

The ability of artificial intelligence / machine learning software to learn from real-world feedback and improve its performance is spurring innovation and leading to the development of novel medical devices. The FDA recognizes AI's advantages and dangers and has started to outline its expectations of industry and device design, programming, unique validation issues, documentation and submissions.

The Nacha Operating Rules are always changing. With an Operations Bulletin (issued March 2023) regarding updates to the WSUD and details on a RFC (Request for Comment) plus an RFI (Request or Information) – this is a must attend session!

EU's New Regulation 536/2014 on Clinical TrialsTo establish that a drug or device is safe and effective, tests are required. There are many preliminary tests, including lab tests, standards, guidances, etc. Finally the product must be tried out on humans / patients in a tightly controlled environmnent.

Achieving high product reliability has become increasingly vital for manufacturers in order to meet customer expectations amid the threat of strong global competition. Poor reliability can doom a product and jeopardize the reputation of a brand or company. Inadequate reliability also presents financial risks from warranty, product recalls, and potential litigation. When developing new products, it is imperative that manufacturers develop reliability specifications and utilize methods to predict and verify that those reliability specifications will be met. This presents a difficult challenge in many industries with short product cycles and compressed product development time frames. This webinar provides an overview of quantitative methods for predicting product reliability from data gathered from physical testing or from field data.

This course will provide a thorough review of regulatory guidelines on method validation and transfer. It provides guidance on how to perform QC analytical test method validations and transfers.

This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs. Demming and others and required also in the CGMPs and under control of variation process guidance.

In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested field-tested individual V&V plans, Test Report / Protocol formats, and individual test cases, IQ, OQ, and PQs, are presented.

Statistical Methods are typically used to ensure that product performance, quality, and reliability requirements are met during the Design Validation phase of product development. This webinar discusses common elements of sample size determination and several specific sample size applications for various design validation activities including Reliability Demonstration/Estimation, Acceptance Sampling, and Hypothesis Testing.