Compliance Training Webinars for Regulated Industries

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.

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.

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.

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.

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.

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.

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

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.

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.

The U.S FDA requires that 21 basic elements be addressed in the traditional 510(k) submission. This can serve as a model for other submissions.

Attend this webinar to learn the importance of doing a complete impact assessment prior to implementation of changes under change control. Tools and techniques will be presented to aid in organizing and streamlining impact assessments.

This webinar will give information on auditing foreign vendors for FDA compliance. It will discuss initiating audits, planning and preparing vendor audits, as well as, monitoring foreign vendor compliance. This webinar will provide FDA guidance on foreign vendor expectations, what to do and what not to upon selecting a foreign vendor. It will also provide audit formats and checklists for ensuring a foreign vendor is qualified.

The webinar will provide useful methods and techniques for conducting a stability study and analyzing the resulting data for the purpose of estimating shelf life. Participants should be able to immediately apply the methods presented. Also, the interpretation and communication of results will be stressed and illustrated in several examples.

This webinar will explain the differences between a GMP audit and a mock regulatory inspection, and will highlight the key considerations for effective conduct of a mock inspection, including problems to avoid.

In this cleaning validation webinar attendees will learn the Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.

This webinar discusses applications of normality testing and several issues that may arise when testing data for normality. Several methods for testing data for normality are presented. We discuss some of the common types of goodness-of-fit tests that may be used (e.g. Andersen-Darling, Kolmogorov Smirnoff, etc.). We also discuss common reasons that normality tests are rejected.

This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.

This webinar course will cover all of the steps necessary in identifying how to properly conduct a workplace accident/incident investigation to drive to the root cause.

This training program will teach attendees best practices on how to perform audits for data integrity within their organization. Attendees will also learn how to centralize management and eliminate silos.

The objective of this live, interactive webinar is to explore the changes to these historic USP test methods, compare them to the new European Pharmacopoeia (EP), 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests and 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms, methodology and how it impacts the typical cGMP microbiological laboratory.