WEBINARS

 

Compliance Training Webinars for Regulated Industries

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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

 

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

 

The 510(k), IDE, Q-Sub, De Novo, and PMA Submission and Approval Process

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706915

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.

Recording Available

* Per Attendee $249

 

Impact Assessment for Change Control

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706337

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.

Recording Available

* Per Attendee $299

 

How to Ensure Your Foreign Vendors are FDA Compliant: Conducting Vendor Audits, Monitoring, and Using Checklists

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 705735

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.

Recording Available

* Per Attendee $249

 

Stability Studies and Estimating Shelf Life

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 706026

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.

Recording Available

* Per Attendee $299

 

Conducting Effective Mock FDA Inspections

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 706913

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.

Recording Available

* Per Attendee $249

 

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 705929

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.

Recording Available

* Per Attendee $249

 

Normality Testing: Applications and Issues

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 706899

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.

Recording Available

* Per Attendee $249

 

Effective Systems for Change Control in the Pharmaceutical Industry

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 705002

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.

Recording Available

* Per Attendee $249

 

Accident/Incident Investigation and Root Cause Analysis

webinar-speaker   Joe Keenan

webinar-time   60 Min

Product Id: 706903

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.

Recording Available

* Per Attendee $249

 

Advanced Auditing for Data Integrity

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 705275

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.

Recording Available

* Per Attendee $249

 

USP <61>/<62> Microbiological Enumeration and Examination of Non-Sterile Products – Understanding the Current Standards for the Revised USP and Harmonized EP Microorganisms

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 706883

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.

Recording Available

* Per Attendee $249

 

Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706879

This webinar will provide valuable guidance to regulated companies in development and implementation of Use Engineering / Human Factors Engineering using the 9 stage model in IEC 62366-1. IEC 62366-2 on recommended implementation considerations will be briefly considered, with the focus on IEC 62366-1, the basic methodology. the webinar willshow when and how these tools are incorporated into R&D design control, risk management, validation, root cause analysis, CAPA / falure investigations, GMP auditing, and liability reduction. Unlike risk management, use engineering may not always be necessary, depending upon the user interface under review. Use engineering is designed to reduce product risk, increase intuitive product use, reduce liability, and less chance of recalls.

Recording Available

* Per Attendee $249

 

 

 

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