WEBINARS

 

Compliance Training Webinars for Regulated Industries

The Unthinkable: Violence in Healthcare from Bullying to an Active Shooter

webinar-speaker   Dr. Susan Strauss

webinar-time   120 Min

Product Id: 704727

The healthcare environment creates a major challenge in the prevention and intervention of violence. The rate of injuries and illness from violence in the healthcare industry is more than three times greater than violence in all private industry. This training program will explore what makes violence in healthcare unique and its negative ramifications on quality patient care.

Recording Available

* Per Attendee $249

 

Medical Device Process Validation Training for Professionals

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 701662

This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, EU MDR, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

Recording Available

* Per Attendee $249

 

Medical Device Non-Product Software Validation Training

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706874

This presentation focuses on the verification and validation planning and execution of software, used in medical device manufacturing, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf), custom, and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. The focus is on the most recent issues the FDA has had in this area, and remediation approaches. Software considered: 1) Production / Test, and 2) QMS / 21 CFR Pt. 11, and 3) Cybersecurity / Networked systems. Examples will be demonstrated. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate.

Recording Available

* Per Attendee $249

 

GMP Compliance for Quality Control and Contract Laboratories

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 706869

This webinar will cover the requirements for laboratory controls under US GMP regulations, such as those relating to equipment calibration and preventive maintenance; sample chain of custody; good documentation practices; investigation of out of specification and out of trend results; analytical method validation; change control; impact of staffing levels and work flow patterns in the lab on GMP compliance; training and other issues.

Recording Available

* Per Attendee $249

 

NEW Nacha Rule – Third-Party Sender (TPS) Roles and Responsibilities

webinar-speaker   Donna K Olheiser

webinar-time   90 Min

Product Id: 706803

This session will help the attendee to identify a Third-Party Sender (TPS) and a “nested” TPS. In addition, we will cover the details needed in the agreements between all parties and what parties based on their role. Discussion on the registration requirement for both the TPS and the nested TPS and what that means to the ODFI.

Recording Available

* Per Attendee $249

 

US FDA Labeling Requirements for Medical Devices

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706873

The definition of labels is well defined and ususally well known; "labeling" not so well. Differing requirements for different applications can be confusing and are the subject of this webinar.

Recording Available

* Per Attendee $249

 

Pharmaceutical Data Integrity

webinar-speaker   Mark Powell

webinar-time   60 Min

Product Id: 706101

Data Integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.

Recording Available

* Per Attendee $299

 

Trial Master File and Clinical Data Management Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 705360

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.

Recording Available

* Per Attendee $249

 

Operational Risk Management Principles

webinar-speaker   Stanley Epstein

webinar-time   90 Min

Product Id: 706024

This webinar provides participants with practical guidance in implementing an effective operational risk management system. It will also bring you up to speed on current best practice in the field of managing operational risk in financial institutions. Not only will we examine the details of each of these principles, as well as taking an all-inclusive look and what needs to happen to implement them; we will complete our journey by examining the principles under the harsh light of an actual Case Study in the banking industry.

Recording Available

* Per Attendee $249

 

Medical Device Change(s) and the 510(k)

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 701742

This 90-minute webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.

Recording Available

* Per Attendee $299

 

Credit Risk Management: Principles and Practices, Tools and Techniques

webinar-speaker   Dev Strischek

webinar-time   120 Min

Product Id: 706863

This course provides guidance in how to implement and maintain the desired level of credit risk management with practical tools and techniques. Both the market and the regulatory agencies expect credit risk management to reflect the bank’s credit culture, so the class also offers direction on how to identify the organization’s credit culture and to reposition it to support the desired credit risk culture and management.

Recording Available

* Per Attendee $199

 

W-2 and W-4 Update and Best Practices

webinar-speaker   Miles Hutchinson

webinar-time   90 Min

Product Id: 704333

This webinar will prepare your staff for this filing year, improve your employee reporting set-up and maintenance practices, and reduce your risk of complaints from the IRS. Learn the latest updates on Form W-4 and Form W-2 wage and withholding reporting.

Recording Available

* Per Attendee $199

 

FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706561

As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed to assure data integrity is maintained. This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.

Recording Available

* Per Attendee $299

 

Supervising a Human Error Free Environment: You can do a Lot More than you Think

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 706861

This training would provide tools that can be implemented and used after this event. This includes practical tools. We will discuss why supervision is so important in reducing and preventing human error. Supervision approaches near root causes and root causes for supervision related errors and will address the main five elements to assure an error-free environment.

Recording Available

* Per Attendee $249

 

Good Laboratory Practices by Using The Quality Management System (QMS)

webinar-speaker   John Fetzer

webinar-time   4 Hrs

Product Id: 706858

This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential benefits, barriers steps to implementing an optimized GLP QMS.

Recording Available

* Per Attendee $399

 

Unauthorized Transactions – Reg E vs Nacha Operating Rules

webinar-speaker   Donna K Olheiser

webinar-time   90 Min

Product Id: 706856

Unauthorized transactions come in many different forms, when returning using Reg E or the Nacha Operating Rules can be confusing. Discussion will include what, why and when while processing unauthorized returns. The trainer will define the limits of liability and who is liable for what amount while providing some real-life scenarios. Details on the error resolution process with Reg E for consumer notification to the financial institution, research time involved, and the timing of providing provisional credit; included will be guidelines on the “what if” there is no error, and providing notice to consumer, and any overdraft protection relating to that provisional credit being reversed. Included will be outlining the ACH return process, when using the ACH network is appropriate, and paperwork/forms needed. Recent Rules changes affecting Nacha compliance when sending unauthorized ACH Returns using Return Reason Codes R10 vs. R11 is included.

Recording Available

* Per Attendee $249

 

Annual Current Good Manufacturing Practices (cGMP) Training

webinar-speaker   Kelly Thomas

webinar-time   60 Min

Product Id: 705422

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

Recording Available

* Per Attendee $249

 

Transfer of Analytical Methods according to USP <1224>

webinar-speaker   Mark Powell

webinar-time   60 Min

Product Id: 706036

In this analytical method transfer webinar attendees will learn the options available for the transfer of validated, non-compendial methods to a different site. In addition to current regulatory guidance, the different options for method transfer will be discussed. The webinar will set out an efficient, risk-based approach that reduces effort whilst meeting the requirements of regulators.

Recording Available

* Per Attendee $299

 

Risk Compliance Matrix for Internal Audit and SOX Operations - Active and Engaged Risk Management Activities

webinar-speaker   Marna Steuart

webinar-time   75 Min

Product Id: 704809

21st century business organizations require active and engaged risk management activities. Today's risk and compliance process is rather complex and dynamic, therefore it requires governance, risk and compliance professionals to possess certain skills in order to effectively complete their duties and responsibilities. The days of using staid audit programs are over. This training program will engage participants in evaluating each business process using a risk-based approach and in preparing risk and compliance documentation for each engagement.

Recording Available

* Per Attendee $249

 

Validation Sampling Plans

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706332

This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.

Recording Available

* Per Attendee $299

 

 

 

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