Validation Statistics for Non-Statisticians
Alan M Golden
60 Min
Product Id: 706944
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
Jose Mora
90 Min
Product Id: 706942
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.
Medical Device Cybersecurity Risk Management Training
Frank Stein
3 Hrs
Product Id: 706560
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.
Statistical Methods for Quality Improvement
Steven Wachs
90 Min
Product Id: 705856
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.
1099 & W-9 Update - Complying with IRS Information Reporting Guidelines
Miles Hutchinson
90 Min
Product Id: 703220
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…
Storm Water Pollution Prevention Plans (SWPPP)
Joe Keenan
90 Min
Product Id: 705510
This webinar will discuss the basics of what is required in a Storm Water Pollution Prevention Plan (SWPPP), how to develop and implement and formalized SWPPP and address site-specific questions and scenarios.
Risk Management for Medical Devices per ISO 14971 2019
Jose Mora
60 Min
Product Id: 706924
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.
How to Comply with FDA Regulations for Tobacco-Related Products: Computer System Validation, 21 CFR Part 11, & Data Integrity
Carolyn Troiano
90 Min
Product Id: 706937
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.
Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals
Kelly Eisenhardt
60 Min
Product Id: 703871
This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.
Conducting Your 2023 Annual ACH Rules Compliance Audit - a Step-by-Step Guide
Donna K Olheiser
90 Min
Product Id: 705082
This session will cover “step-by-step” the audit process and requirements for each participant conducting an annual ACH audit, to help ensure their compliance with the Nacha Operating Rules.
Aseptic Processing Overview and Validation
Kelly Thomas
90 Min
Product Id: 706212
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
US FDA's AI Framework for Medical Devices
John E Lincoln
90 Min
Product Id: 706934
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.
2022/2023 NEW Nacha Rules Changes: Discover the Impacts and Develop Strategies for Your Rules Compliance
Donna K Olheiser
90 Min
Product Id: 705048
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 Trials
John E Lincoln
90 Min
Product Id: 706914
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.
Predicting Product Life Using Reliability Analysis Methods
Steven Wachs
90 Min
Product Id: 702096
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.
Analytical Method Validation and Transfer
Kelly Thomas
90 Min
Product Id: 706186
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.
CGMP Manufacturing Methods: P&PC and SPC
John E Lincoln
90 Min
Product Id: 706929
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.
NEW Reclamation Process (effective 1-1-23) with ACH Federal Government Reclamations, plus guidance on Misdirected Payments and DNE's (Death Notification Entries)
Donna K Olheiser
90 Min
Product Id: 706928
Processing ACH Reclamations from the Federal Government can be challenging! Chapter 5 of the Green Book has been updated making it mandatory for Financial Institutions to respond to all reclamations must be submitted through the Automated Reclamation Processing System (ARPS) located in Treasury’s Pay.gov web portal (except for responses by DFAS and any Treasury-approved exceptions). The Nacha Operating Rules still apply when processing these payments but the Green Book outlines exceptions when handling DNEs (Death Notification Entries) and Federal Government Reclamations. A side-by-side comparison of Commercial vs. Government Reclamations will be included to know what the difference is and how to handle each one.
Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
John E Lincoln
90 Min
Product Id: 700149
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.
Good Documentation Practice (GDP) and FDA Validation Compliance for Regulated Computer Systems and Data
Carolyn Troiano
90 Min
Product Id: 706925
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data. Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.