WEBINARS

 

Compliance Training Webinars for Regulated Industries

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How to Comply with FDA Regulations for Tobacco-Related Products: Computer System Validation, 21 CFR Part 11, & Data Integrity

webinar-speaker   Carolyn Troiano

webinar-time   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.

Recording Available

* Per Attendee $249

 

Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

webinar-speaker   Kelly Eisenhardt

webinar-time   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.

Recording Available

* Per Attendee $249

 

Conducting Your 2023 Annual ACH Rules Compliance Audit - a Step-by-Step Guide

webinar-speaker   Donna K Olheiser

webinar-time   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.

Recording Available

* Per Attendee $299

 

Aseptic Processing Overview and Validation

webinar-speaker   Kelly Thomas

webinar-time   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.

Recording Available

* Per Attendee $299

 

US FDA's AI Framework for Medical Devices

webinar-speaker   John E Lincoln

webinar-time   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.

Recording Available

* Per Attendee $249

 

2022/2023 NEW Nacha Rules Changes: Discover the Impacts and Develop Strategies for Your Rules Compliance

webinar-speaker   Donna K Olheiser

webinar-time   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!

Recording Available

* Per Attendee $249

 

EU's New Regulation 536/2014 on Clinical Trials

webinar-speaker   John E Lincoln

webinar-time   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.

Recording Available

* Per Attendee $249

 

Predicting Product Life Using Reliability Analysis Methods

webinar-speaker   Steven Wachs

webinar-time   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.

Recording Available

* Per Attendee $249

 

Analytical Method Validation and Transfer

webinar-speaker   Kelly Thomas

webinar-time   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.

Recording Available

* Per Attendee $299

 

CGMP Manufacturing Methods: P&PC and SPC

webinar-speaker   John E Lincoln

webinar-time   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.

Recording Available

* Per Attendee $249

 

NEW Reclamation Process (effective 1-1-23) with ACH Federal Government Reclamations, plus guidance on Misdirected Payments and DNE's (Death Notification Entries)

webinar-speaker   Donna K Olheiser

webinar-time   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.

Recording Available

* Per Attendee $249

 

Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements

webinar-speaker   John E Lincoln

webinar-time   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.

Recording Available

* Per Attendee $299

 

Good Documentation Practice (GDP) and FDA Validation Compliance for Regulated Computer Systems and Data

webinar-speaker   Carolyn Troiano

webinar-time   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.

Recording Available

* Per Attendee $249

 

Sample Size Determination for Design Validation Activities

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 705852

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.

Recording Available

* Per Attendee $299

 

Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 706927

This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources, and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, Data Trending, Microbiological processes/methodology, Cleanroom cleaning/disinfection.

Recording Available

* Per Attendee $299

 

Risk Management of Raw Materials in a GMP Environment

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 706909

The objective of this live, interactive webinar is to explore raw materials in a cGMP environment, their various regulatory requirements and how they may affect the timeline of meeting the release date of your Company’s products. Please plan to bring additional personnel to the webinar to obtain cross-Departmental training.

Recording Available

* Per Attendee $249

 

Test Method / Design Verification and Validation

webinar-speaker   John E Lincoln

webinar-time  

Product Id: 706920

Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design Verification and Validation under U.S. FDA cGMP, EU MRD and ISO 14971

Recording Available

* Per Attendee $249

 

Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning the Agile Methodology to the GAMP®5 "V" Model and System Development Life Cycle (SDLC) Methodology

webinar-speaker   Carolyn Troiano

webinar-time   120 Min

Product Id: 706921

As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. adopting best quality practices. There has also been a lower than anticipated investment in automation and digital technologies, which could greatly improve quality and process control. A key element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) waterfall approach. This encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation driven approaches.

This is where FDA determined that “WHAT” is required can be done (the “HOW”) in different ways and does not have to be according to the “checklist” mindset of most CSV work, where you create documents without specifically addressing the risk of potential failure of each requirement.

GAMP®5 supports the use of incremental, iterative, and evolutionary approaches including agile, for development of custom applications. Keys to success include a robust Quality Management System and well trained and highly disciplined teams following well-defined processes supported by tools and automation.

Recording Available

* Per Attendee $299

 

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

webinar-speaker   Steven Wachs

webinar-time   75 Min

Product Id: 705020

This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.

Recording Available

* Per Attendee $299

 

Terminally Sterilized Pharmaceutical Products – Parametric Release ( New USP<1222>, November 2019) and its Relationship to the new British Terminal Steriliation Methodology (March 2019)

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 706908

This General Information Chapter (USP<1222>) will first cover the general issues related to parametric release, regardless of the modes of sterilization, and then discuss some specific modes of sterilization. It will also include information on USP<55> Biological Indicators as well as EU “Guideline on the Sterilization of Medicinal Products…” (March 2019). The webinar will discuss why it provides more accurate information than the sterility test regarding the release of terminally sterilized product to the marketplace.

Recording Available

* Per Attendee $249

 

 

 

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