WEBINARS

 

Compliance Training Webinars for Regulated Industries

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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 $299

 

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 $299

 

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

 

GAMP Data Integrity 21 CFR Part 11 Training Course

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 706912

This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.

Recording Available

* Per Attendee $249

 

How To Create an Effective Export Control Compliance Program under the Export Administration Regulations in 2023

webinar-speaker   Douglas Cohen

webinar-time   60 Min

Product Id: 703983

This training program will assist attendees in establishing and enhancing an export compliance program and offer best practices for export compliance given under the Export Administration Regulations (EARs).

Recording Available

* Per Attendee $149

 

Useful Statistical Methods for Defining Product and Process Specifications - Part II

webinar-speaker   Steven Wachs

webinar-time   75 Min

Product Id: 706898

This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications. Appropriate product specifications are critical to achieving adequate and reliable product performance.

Recording Available

* Per Attendee $249

 

How to Prepare an Effective Audit Manual for an Internal Audit Department

webinar-speaker   Marna Steuart

webinar-time   60 Min

Product Id: 703684

This webinar will instruct attendees on how to develop an internal audit manual and offer start to finish instructions and templates on how to perform different types of audits given the project description. Audit fieldwork, audit reporting and follow-up, work-paper filing, and project closure are some of the other areas the webinar will cover.

Recording Available

* Per Attendee $249

 

How to Create Clinical Evaluation According to EU MDR 2017/745 Article 61 and Annex XIV

webinar-speaker   Frank Stein

webinar-time   75 Min

Product Id: 706887

Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system and your technical documentation. Your implementation needs smart ideas to reach the right level to pass the quality management audits and technical documentation audits and review by your notified body.

Recording Available

* Per Attendee $249

 

Monitoring High Risk Transactions

webinar-speaker   Doug Keipper

webinar-time   60 Min

Product Id: 703001

This BSA/AML (Bank Secrecy Act/ Anti Money Laundering) compliance training will help attendees understand, identify and mitigate the risks associated with high risk transactions.

Recording Available

* Per Attendee $249

 

Cybersecurity and US FDA Requirements

webinar-speaker   John E Lincoln

webinar-time  

Product Id: 706716

Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information.

Recording Available

* Per Attendee $299

 

Workplace Violence Prevention

webinar-speaker   Joe Keenan

webinar-time   60 Min

Product Id: 705522

This webinar will teach you how to get proactive and put programs in place to prevent a workplace violence episode and how to respond to an active shooter scenario. This training will discuss in detail the Do's and Don'ts in reference to workplace violence prevention.

Recording Available

* Per Attendee $179

 

Knowing your Post-Market Clinical Follow-up (PMCF)

webinar-speaker   Frank Stein

webinar-time   60 Min

Product Id: 706888

Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in clinical post market surveillance into your current quality management system according to ISO 13485:2021. Your implementation needs smart ideas to reach the right level to pass the quality management audit by your notified body or authority inspection.

Recording Available

* Per Attendee $249

 

Useful Statistical Methods for Defining Product and Process Specifications - Part I

webinar-speaker   Steven Wachs

webinar-time   75 Min

Product Id: 706897

This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications. Appropriate product specifications are critical to achieving adequate and reliable product performance.

Recording Available

* Per Attendee $249

 

 

 

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