ComplianceOnline

Energy and Utilities Regulatory Compliance Training - Live Webinars, Recordings & CDs

EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials and Drug Development
23
/ Oct
Tuesday-2018

EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials and Drug Development

  • Speaker: Laura Brown
  • Product ID: 705850
  • Duration: 90 Min
This webinar will discuss the new GDPR regulation requirements in the context of clinical trial data, how it applies to clinical trials and pharma industry, the personal data types including clinical trial data, what are the rights of clinical trials subjects, data access requests, informed consent, how to transfer clinical trial data outside EU, data breach reporting, penalties and how to put a data governance program and process to comply with GDPR regulations.
* Per Attendee
$169
Stunning Changes in FDA's Software Regulation
23
/ Oct
Tuesday-2018

Stunning Changes in FDA's Software Regulation

  • Speaker: Casper Uldriks
  • Product ID: 705820
  • Duration: 60 Min
This webinar will highlight the changing circumstances with respect to software regulations and FDA’s approach from a regulation to voluntary standard. How to understand the qualifications and terms of participation to clear its software for marketing, what to do in case of cybersecurity intrusion and how to update regulatory program as mobile apps are removed from FDA’s regulatory oversight.
Gaining and Re-establishing Control of Your Cleanroom
23
/ Oct
Tuesday-2018

Gaining and Re-establishing Control of Your Cleanroom

  • Speaker: Joy McElroy
  • Product ID: 705317
  • Duration: 60 Min
This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.
* Per Attendee
$199
Bank Secrecy Act (BSA) -  KYC, CTRs, SARs, Title 31, Compliance & New CDD Requirements
23
/ Oct
Tuesday-2018

Bank Secrecy Act (BSA) - KYC, CTRs, SARs, Title 31, Compliance & New CDD Requirements

  • Speaker: Jim George
  • Product ID: 705827
  • Duration: 60 Min
This BSA/AML webinar will discuss various compliance requirements for AML - KYC, CTRs, SARs, new customer due-diligence process and various strategies which money launderers are using now and how to detect and thwart it.
* Per Attendee
$169
A Primer on Acute Care Reimbursement: From DRGs to Bundled Payments
23
/ Oct
Tuesday-2018

A Primer on Acute Care Reimbursement: From DRGs to Bundled Payments

  • Speaker: Toni Cesta
  • Product ID: 705824
  • Duration: 60 Min
This webinar will help understand DRG system used as the structure for reimbursement under Medicare/Medicaid programs including review of DRG relative weights, case mix index, length of stay, medical record coding, managed care contracting, bundled payments and strategies to control cost and length of stay in bundled payment environment.
* Per Attendee
$199
3-Hr Virtual Seminar: Import and Export with Latin America: Argentina, Brazil and Venezuela
23
/ Oct
Tuesday-2018

3-Hr Virtual Seminar: Import and Export with Latin America: Argentina, Brazil and Venezuela

  • Speaker: Raymond Sullivan
  • Product ID: 704646
  • Duration: 3 hrs
This training program on Latin America import and export will detail the US requirements to export and import procedures to Latin America. It will also discuss commercial and customs document requirements, tariffs and applicable duties, countervailing and antidumping duties, and highlight the difference between automatic and non-automatic import licenses.
* Per Attendee
$299
3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods – Implementing Guidelines from FDA/EMA, USP and ICH
24
/ Oct
Wednesday-2018

3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods – Implementing Guidelines from FDA/EMA, USP and ICH

  • Speaker: Dr. Ludwig Huber
  • Product ID: 705753
  • Duration: 3 hrs
This 3-Hr webinar on “Validation and Verification of Analytical Methods” by Dr. Huber will discuss the recent changes in guidance from regulatory agencies (FDA/EMA, USP and ICH) on method validation and transfer, integrated validation, verification and validation of analytical procedures for equivalency testing and statistical evaluation. He will teach how to execute document development, how to demonstrate FDA and EU compliance to auditors and inspectors, how to explain company’s strategy for method validation, verification, transfer and equivalency testing etc.
* Per Attendee
$449
Pregnancy at Work: 2018 Enforcement Guidance with Pregnant Employees and New Parents
24
/ Oct
Wednesday-2018

Pregnancy at Work: 2018 Enforcement Guidance with Pregnant Employees and New Parents

  • Speaker: U Harold Levy
  • Product ID: 705773
  • Duration: 60 Min
This webinar will discuss differences between Pregnancy Discrimination Act (PDA) and the Family and Medical Leave Act (FMLA), disability and maternity leave, what benefits apply to new parents, what documentation required for pregnancy related absences, how to discipline a pregnant employee to avoid any kind of pregnancy discrimination complaints.
* Per Attendee
$159
3-hr Virtual Seminar: The ISO 13485 and ICH-10 Quality Manuals for the FDA Regulated Industry
25
/ Oct
Thursday-2018

3-hr Virtual Seminar: The ISO 13485 and ICH-10 Quality Manuals for the FDA Regulated Industry

  • Speaker: Howard Cooper
  • Product ID: 705843
  • Duration: 3 hrs
This webinar explains how the ISO 13485 (Medical Devices) & ICH Q10 (Pharmaceuticals) quality manuals create a systematic, formal and collaborative approach for establishing roles, authorities and responsibilities in the planning, development, and implementation of inter-functional cGMP procedures (i.e. Incoming Material Control, Change Control, & Design Control), required by FDA regulations. Particularly applicable are 21 CFR Parts 210-211, Parts 803, 810 & 820, & ICH Q7A. The Quality Manual (QM) synchronizes the law and regulations with quality principles, industry practice, and the writings of “quality gurus”. The organization of the QM’s Table of Contents predicts how well the company understands and practices quality concepts.
* Per Attendee
$299
Medicare's New Payment System for Laboratory Services - Competitive Landscape and Viability Strategies
25
/ Oct
Thursday-2018

Medicare's New Payment System for Laboratory Services - Competitive Landscape and Viability Strategies

  • Speaker: Dennis Weissman
  • Product ID: 705828
  • Duration: 60 Min
This webinar will discuss how Protecting Access to Medicare Act (PAMA) is resetting competition between independent and hospital outreach labs, how PAMA will affect lab rates for other payers and what outreach lab programs can do to retain more advantageous reimbursements from commercial payer.
* Per Attendee
$169
Proving and Pricing Subcontractor Delay Claims
25
/ Oct
Thursday-2018

Proving and Pricing Subcontractor Delay Claims

  • Speaker: Jim Zack
  • Product ID: 704584
  • Duration: 90 Min
This webinar will discuss causes of subcontractor delay and impact claims. Attendees will be exposed to contractual issues surrounding subcontractor delay claims and learn the theories of recovery a subcontractor can employ when pursuing a delay claim against the General Contractor. The program will identify practical problems concerning subcontractor delay claims from the project owner’s viewpoint and discusses what damages may flow from subcontractor delay claims and the recoverability of such damages.
* Per Attendee
$149
Extractables and Leachables in Early Phase Development
25
/ Oct
Thursday-2018

Extractables and Leachables in Early Phase Development

  • Speaker: Wayland Rushing
  • Product ID: 704517
  • Duration: 60 Min
This training program will offer insight into where extractables and leachables come from. Attendees will learn the regulatory expectations and trends for extractables and leachables in early phase development and learn which products may require E&L data in early phases. The program will also focus on how to design programs to meet the needs of early phase development – i.e. phase appropriate E&L programs.
* Per Attendee
$229
Workplace Violence Prevention Programs Including Active Shooter Scenarios
25
/ Oct
Thursday-2018

Workplace Violence Prevention Programs Including Active Shooter Scenarios

  • Speaker: Joe Keenan
  • Product ID: 705522
  • Duration: 90 Min
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.
* Per Attendee
$149
Auditing and examining Travel and Entertainment Expenses: Expense Reimbursement Fraud
26
/ Oct
Friday-2018

Auditing and examining Travel and Entertainment Expenses: Expense Reimbursement Fraud

  • Speaker: Lynn Fountain
  • Product ID: 703767
  • Duration: 90 Min
This training program will address why internal controls over travel and entertainment (T&E) expenditures are a critical component of the control environment. Although the topic of travel and entertainment abuse is not one that management likes to address, it is a very important indicator of the adequacy of a company’s control environment.
* Per Attendee
$199
2018 New Privacy Officer Training - Module 1
29
/ Oct
Monday-2018

2018 New Privacy Officer Training - Module 1

  • Speaker: Nanette Awad
  • Product ID: 705832
  • Duration: 75 Min
HIPAA Privacy Officer Training will provide a comprehensive overview of all ongoing activities of a Privacy Program related to the development, implementation, maintenance of, and adherence to the organization’s policies and procedures covering the privacy of, and access to, patient health information in compliance with federal and state laws and the healthcare organization’s information privacy practices.
* Per Attendee
$199
Recorded/CD
Recognizing and Managing Emerging Operational Risks

Recognizing and Managing Emerging Operational Risks

  • Speaker: Daniel Clark
  • Product ID: 705588
  • Duration: 60 Min
This webinar reviews the different definitions behind the concept of emerging risks, the different types of operational risks impacting firms today. Then, the webinar moves on to the principles of monitoring and mitigating some of these emerging risks, highlighting useful principles of risk identification and risk management.
CD/Recorded
$199
Recorded/CD
Data Integrity of GxP/GMP Data: e-Discovery and Crisis Preparedness

Data Integrity of GxP/GMP Data: e-Discovery and Crisis Preparedness

  • Speaker: Eleonora Babayants
  • Product ID: 705781
  • Duration: 90 Min
Learn how to secure, manage and govern data as well as IT systems in compliance with GxP/GMP requirements and be able to pass quality audit. Understand GMP requirements for IT systems, data security and data governance procedures, e-discovery and crisis preparedness plan and how to implement it in time.
Recorded/CD
Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>

Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>

  • Speaker: Gregory Martin
  • Product ID: 705325
  • Duration: 90 Min
This webinar provides understanding of the requirements for residual solvents addressed in ICH, USP, EP and JP and focus on the recent changes to USP <467>. It will also help attendees utilize strategies to minimize the testing and resources required to meet the requirements.
CD/Recorded
$249
Recorded/CD
Challenges with ASC Insurance Contracting vs. Out of Network Billing

Challenges with ASC Insurance Contracting vs. Out of Network Billing

  • Speaker: Stephanie Thomas
  • Product ID: 705676
  • Duration: 60 Min
This webinar will discover the top trends ASC facilities are facing with contracting with Medicare and third party payers. You will get the tips and tricks to ensure your negotiations are successful. You will learn to weigh the pros and cons of contracting to decide if out-of-network billing may be the best route for your business.
CD/Recorded
$229
Recorded/CD
Three Key Risk Assessments in Your ERM Program - ERM, IT, and Internal Controls

Three Key Risk Assessments in Your ERM Program - ERM, IT, and Internal Controls

  • Speaker: Marci Malzahn
  • Product ID: 705777
  • Duration: 90 Min
This risk assessment webinar will discuss how to do perform risk assessments for ERM, IT and Internal control function of your organization. Attendees will learn how to create/develop risk assessments, how to complete the ERM Risk Assessment using the ERM Risk Assessment Matrix. And how to complete the general IT Risk Assessment as well as a thorough Risk Assessment for your Internal Controls.
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