ComplianceOnline

Regulatory Affairs Training - Live Webinars, Recordings & CDs

Software Validation and its 11 Key Documents
17
/ Apr
Wednesday-2019

Software Validation and its 11 Key Documents

  • Speaker: John E Lincoln
  • Product ID: 703097
  • Duration: 90 Min
This webinar focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) 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. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.
* Per Attendee
$249
The Complexity and Interplay Among ADAAA, FMLA, and Worker's Comp (WC) - How Do They Work Together, or Not?
17
/ Apr
Wednesday-2019

The Complexity and Interplay Among ADAAA, FMLA, and Worker's Comp (WC) - How Do They Work Together, or Not?

  • Speaker: Dr. Susan Strauss
  • Product ID: 704959
  • Duration: 120 Min
The webinar training will address ADAAA, FMLA, and Worker’s Comp laws that HR is responsible for upholding. When the laws are not followed, it increases the liability for the organization and interferes with a fair and equitable work environment for employees.
* Per Attendee
$199
Sarbanes-Oxley Act Section 404: How to Establish an Effective Internal Controls System
18
/ Apr
Thursday-2019

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.
* Per Attendee
$199
Multistate Taxation - Fundamentals and Best Practices for Handling Multistate employees
19
/ Apr
Friday-2019

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.
* Per Attendee
$199
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
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
New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

  • Speaker: Angela Bazigos
  • Product ID: 704529
  • Duration: 90 Min
This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.
CD/Recorded
$249
Recorded/CD
How to Conduct Annual Product Reviews to Achieve GMP Compliance

How to Conduct Annual Product Reviews to Achieve GMP Compliance

  • Speaker: Danielle DeLucy
  • Product ID: 704993
  • Duration: 60 Min
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.
CD/Recorded
$299
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