
Impact Assessment for Change Control
Alan M Golden
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.

Critical Anti-Fraud Audits under Procurement and Accounts Payable
Marna Steuart
60 Min
Product Id: 703533
This webinar will explain how to perform anti-fraud audits in the purchasing/accounts payable cycle. It will discuss the use of Audit Control Language (ACL) and how this tool and other tools like it (IDEA) are helpful in the analysis of accounts payable and purchasing data.

Normality Testing: Applications and Issues
Steven Wachs
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.

US Economic Sanctions on Russia: How To Reduce Your Exposure and Be Compliant
Douglas Cohen
60 Min
Product Id: 706906
This webinar will provide you a basic, “Russian Sanctions Compliance Program” for you to implement into your import-export procedures and also closely examine the specific export and financial sanctions against Russia and Belarus, and show you how to reduce your exposure to these new penalties by being compliant.

Report Writing for Auditing Professionals
Phil Vassallo
90 Min
Product Id: 703814
Skilled auditors require a method that aligns what they experienced during the reviewing process with what they compose during the writing process. This report writing workshop will provide foundation resources that participants can continually turn to during intense, complex audit engagements.

Tax Evasion and Tax Fraud - What it means to you when monitoring BSA and filing SARs
Doug Keipper
60 Min
Product Id: 703110
This training on BSA compliance will help you understand the concept of tax evasion and tax fraud and the difference between the two. Learn the best practices to identify tax fraud and how to report suspicious activity.

Medical Devices Periodic Safety Update Report (PSUR)
John E Lincoln
90 Min
Product Id: 706880
PSURs are pharmacovigilance and device adverse events documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorization in the EU. The purpose is to harmonize and strengthen benefit-risk review of medical products across the European Economic Area.

Conducting Effective Mock FDA Inspections
David L Chesney
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.

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
Joy McElroy
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.

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

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

EU's New Regulation 535/2014 on Clinical Trials
John E Lincoln
90 Min
Product Id: 706914
EU's New Regulation 535/2014 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.

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

Risk Management of Raw Materials in a GMP Environment
Barry A Friedman
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.
The 6 Most Common Problems in FDA Software Validation and Verification
David Nettleton
120 Min
Product Id: 705582
This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

Wage Payment Irregularities/ Dealing with Disruptions in the Payroll Process
Patrick A Haggerty
90 Min
Product Id: 706901
This webinar provides overview of common problems encountered in payroll and methods for prevention, mitigation and resolution. The discussion will include when use of specific forms may be required, such as Form 941-X, Adjusted Employer's Quarterly Federal Tax Return or Claim for Refund and Form W-2C, Corrected Wage and Tax Statement. Special procedures related to fringe benefit withholding, deceased employee wages and misclassified employees will be covered.

Accident/Incident Investigation and Root Cause Analysis
Joe Keenan
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.

Risk Management and The New General Chapter, USP<60>, Burkholderia cepacia
Barry A Friedman
90 Min
Product Id: 706907
The Objective of this live, interactive training webinar is to explore the various issues surrounding the history of B. cepacia and its Complex and examine solutions to common microbiological problems. It will discuss the General Chapter USP<60> which was issued December 2019, media that is used, as well as consider recalls, FDA 483s and Warning Letters. The webinar will also review why 16S rRNA identification will not work satisfactorily with this Complex. Please plan to bring an interdisciplinary team to this Webinar to explore how knowledge regarding this contaminant may assist you in your facilities and minimize it as an Objectionable microorganism.

Advanced Auditing for Data Integrity
Joy McElroy
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.

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