ComplianceOnline

Regulatory Affairs Training - Live Webinars, Recordings & CDs

Creating a Risk-based Supplier Management program
24
/ Apr
Wednesday-2019

Creating a Risk-based Supplier Management program

  • Speaker: Betty Lane
  • Product ID: 702501
  • Duration: 75 Min
This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest FDA, European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while potentially reducing your cost of compliance.
* Per Attendee
$229
Project Management for Auditors - Improving audit productivity for GCP, GMP and GLP
24
/ Apr
Wednesday-2019

Project Management for Auditors - Improving audit productivity for GCP, GMP and GLP

  • Speaker: Laura Brown
  • Product ID: 701982
  • Duration: 60 Min
This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.
* Per Attendee
$229
Enforcement Actions and how they can affect your Institution
24
/ Apr
Wednesday-2019

Enforcement Actions and how they can affect your Institution

  • Speaker: Thomas Nollner
  • Product ID: 705503
  • Duration: 60 Min
This webinar will review the regulatory history and background of the financial institution involved, the findings of the regulators and law enforcement during examinations and onsite reviews, the reasoning behind the enforcement actions, and the expectation of the regulators and law enforcement going forward. It will further discuss policy changes, procedure enhancements, and operational practices the financial institution could have taken to prevent the weaknesses that caused the enforcement action.
* Per Attendee
$199
The Healthcare Quality Improvement Act: Achieving Immunity in Your Peer Review Process
24
/ Apr
Wednesday-2019

The Healthcare Quality Improvement Act: Achieving Immunity in Your Peer Review Process

  • Speaker: William Mack Copeland
  • Product ID: 704388
  • Duration: 60 Min
In this training program, attendees will gain an understanding of how the HCQIA protects your organization and on those who participate in the peer review process in your organization. They will also gain an appreciation of the actions that are required to perfect HCQIA immunity. Failure to take the appropriate actions and to follow the correct protocol can result in confusion.
* Per Attendee
$199
CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
24
/ Apr
Wednesday-2019

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

  • Speaker: Sunil Gupta
  • Product ID: 704302
  • Duration: 90 Min
This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.
* Per Attendee
$249
Contemporary Case Management Staffing and Models: Best Practices in the Era of Value-Based Purchasing
24
/ Apr
Wednesday-2019

Contemporary Case Management Staffing and Models: Best Practices in the Era of Value-Based Purchasing

  • Speaker: Toni Cesta
  • Product ID: 705424
  • Duration: 60 Min
This webinar will review contemporary, best practice, case management models including descriptions of the two most commonly used models, the key differences between the models, as well as how they should be designed and structured. The webinar will also discuss the steps needed to re-engineer a case management department and tips for identifying the best model for your organization.
* Per Attendee
$199
Human Error Investigations, Root Cause Determination and CAPA Effectiveness
25
/ Apr
Thursday-2019

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

  • Speaker: Ginette M Collazo
  • Product ID: 704314
  • Duration: 90 Min
This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.
* Per Attendee
$249
Good Documentation Guideline (Chapter <1029> USP)
26
/ Apr
Friday-2019

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
* Per Attendee
$229
Pricing Contractor Jobsite Overhead Delay Costs
26
/ Apr
Friday-2019

Pricing Contractor Jobsite Overhead Delay Costs

  • Speaker: Jim Zack
  • Product ID: 704367
  • Duration: 90 Min
After attending this training program, attendees will have a better understanding of the issues concerning the pricing of contractor delay damages. Contractors will gain knowledge about the various methods of calculating extended field office overhead costs. Owners will learn some contractual methods for predetermining this element of delay costs in order to prevent the need for end of the job audits or disputes over such costs.
* Per Attendee
$149
Inexpensive Food Safety and Traceability Solutions Using Process and Quality Control Concepts
30
/ Apr
Tuesday-2019

Inexpensive Food Safety and Traceability Solutions Using Process and Quality Control Concepts

  • Speaker: John Ryan
  • Product ID: 701866
  • Duration: 60 Min
This Food Safety system webinar focus on how effectively basic process and quality control concepts that can be implemented in time in any food handling operation.
* Per Attendee
$199
USA Import Compliance Program and Written Procedures
30
/ Apr
Tuesday-2019

USA Import Compliance Program and Written Procedures

  • Speaker: Jan Seal
  • Product ID: 705467
  • Duration: 90 Min
Learn how to pass a focused assessment by the US CBPs Regulatory Audit Division, reduce your risk of non-compliance with import requirements and evaluation of internal controls.
* Per Attendee
$199
Handling OOS Test Results and Completing Robust Investigations
2
/ May
Thursday-2019

Handling OOS Test Results and Completing Robust Investigations

  • Speaker: Danielle DeLucy
  • Product ID: 704351
  • Duration: 90 Min
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
* Per Attendee
$199
Handling Payroll Overpayments Correctly
2
/ May
Thursday-2019

Handling Payroll Overpayments Correctly

  • Speaker: Vicki M. Lambert
  • Product ID: 703942
  • Duration: 90 Min
This training program will examine the FLSA requirements on recouping overpayments including the 1998 opinion letter that spells out these requirements. It will also focus on issues such as exempt employee status, minimum wage and overtime rules for nonexempt employees must be considered when recovering overpayments from employees. Additionally, it will review the wage and hour laws of several states and the factors that determine if an overpayment can be recouped.
* Per Attendee
$199
Compliance Measures for Case Managers
2
/ May
Thursday-2019

Compliance Measures for Case Managers

  • Speaker: Toni Cesta
  • Product ID: 705318
  • Duration: 60 Min
This program will review the compliance issues that most greatly impact your practice such as the 2-midnight rule, the NOTICE Act, HINNs, the important message from Medicare and others. The Joint Commission is now monitoring these issues when they have deemed status from Medicare, so your compliance is critical to a good Joint Commission survey outcome. This program will help you to identify where you may have compliance practice gaps as well as how to fix them.
* Per Attendee
$199
Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements
7
/ May
Tuesday-2019

Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

  • Speaker: John E Lincoln
  • Product ID: 701898
  • Duration: 90 Min
This 90-minute webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities, differences, interrelationships, and similarities.
* Per Attendee
$199
Recorded/CD
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705583
  • Duration: 60 Min
In this webinar you will gain a basic to moderate knowledge of definition, purpose, importance of GDP, General rules of GDP, GDP as applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029> introduction “Good Documentation Guidelines”, A very brief introduction to European Union (EU) GDP, and finally its enforcement along with some observation samples from FDA.
CD/Recorded
$299
Recorded/CD
Documentation of Medical Necessity - Focus for OIG and other auditors

Documentation of Medical Necessity - Focus for OIG and other auditors

  • Speaker: Laura S Hargraves
  • Product ID: 705139
  • Duration: 60 Min
This medical necessity documentation webinar will cover all the key information needed to support your efforts to document and demonstrate Medical Necessity of services.
CD/Recorded
$249
Recorded/CD
21 CFR 11 Compliance for Excel Spreadsheet

21 CFR 11 Compliance for Excel Spreadsheet

  • Speaker: Angela Bazigos
  • Product ID: 702450
  • Duration: 90 Min
This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Part 11 validation.
CD/Recorded
$249
Recorded/CD
Multistate Taxation - Fundamentals and Best Practices for Handling Multistate employees

Multistate Taxation - Fundamentals and Best Practices for Handling Multistate employees

  • Speaker: Vicki M. Lambert
  • Product ID: 702984
  • Duration: 90 Min
Attend this webinar to learn payroll best practices (handling of state taxes, wage and hour law, and garnishments) when an employee lives in one state and works in another, or works in two or more states simultaneously. This Includes determining liability as an employer, reciprocal agreements, resident and nonresident taxation, Form W-4 equivalents, state unemployment insurance, wage and hour law requirements and garnishment withholding.
CD/Recorded
$249
Recorded/CD
Sarbanes-Oxley Act Section 404: How to Establish an Effective Internal Controls System

Sarbanes-Oxley Act Section 404: How to Establish an Effective Internal Controls System

  • Speaker: David Sanders
  • Product ID: 704395
  • Duration: 90 Min
This webinar will enhance your knowledge of SOX Section 404 (Sarbanes-Oxley Act Section 404) by helping you understand the elements of an internal controls system. Internal controls are a key part of any organization's continued growth, performance and success. With fraud at an all-time high, a well-designed internal control structure will enhance operations by improving your department's overall security and effectiveness. SOX Section 404 mandates that all publicly-traded companies must establish internal controls and procedures for financial reporting and must document, test and maintain those controls and procedures to ensure their effectiveness.
CD/Recorded
$249
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