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Home › Online Training ›  FDA Training

FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

Sub Categories: Risk Management | Packaging and Labeling | FDA Audit and Inspection | Drug and Device Approvals | FDA Validation | FDA 21 CFR Part 11 | Marketing and Promotion | Documentation and IT | Quality and Safety | Regulations & Guidances | Best Practices & GXPs
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Basic, Easy-to-Follow Pivot Tables Including an Introduction to Dashboards
22
/ Oct
Monday-2018

Basic, Easy-to-Follow Pivot Tables Including an Introduction to Dashboards

  • Speaker: Joe Weil
  • Product ID: 705044
  • Duration: 100 Min
This Excel training program will guide users in employing Pivot Table filters to analyze data, designing a Pivot Chart from a Pivot Table, developing Slicers for User Interactive Filters, and more. It will also take attendees through the first steps in dashboard design using Pivot Tables.
* Per Attendee
$179
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Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
22
/ Oct
Monday-2018

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

  • Speaker: Roger Cowan
  • Product ID: 703727
  • Duration: 60 Min
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.
* Per Attendee
$199
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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
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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.
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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
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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
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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
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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
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Steam Sterilization Microbiology and Autoclave Performance Qualification
24
/ Oct
Wednesday-2018

Steam Sterilization Microbiology and Autoclave Performance Qualification

  • Speaker: Danielle DeLucy
  • Product ID: 705027
  • Duration: 90 Min
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
* Per Attendee
$199
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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
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Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>
24
/ Oct
Wednesday-2018

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.
* Per Attendee
$199
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Challenges with ASC Insurance Contracting vs. Out of Network Billing
24
/ Oct
Wednesday-2018

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.
* Per Attendee
$179
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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
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Three Key Risk Assessments in Your ERM Program - ERM, IT, and Internal Controls
24
/ Oct
Wednesday-2018

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.
* Per Attendee
$199
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Basic Requirements for IQ, OQ and PQ Protocols
24
/ Oct
Wednesday-2018

Basic Requirements for IQ, OQ and PQ Protocols

  • Speaker: Kenneth Christie
  • Product ID: 704591
  • Duration: 60 Min
This training program will provide an outline of the typical protocols used for documentation of qualification activities, the type of information normally included in each and the common deficiencies cited when audited. It will highlight the importance of establishing specifications for all test challenges, proper documentation with regards to results obtained, how to address deviations encountered and how best to summarize results obtained.
* Per Attendee
$229
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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
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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.
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Recorded/CD
Fishbone Diagramming

Fishbone Diagramming

  • Speaker: Michael Abitz
  • Product ID: 705338
  • Duration: 90 Min
This webinar will teach you how to identify potential process problems and avoid process interactions through effective process mapping. It will cover steps to create a fishbone diagram including its purpose, advantages and how to present it.
CD/Recorded
$229
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Recorded/CD
Weed, Cocaine and Heroin: What it Means to Your Bank or Credit Union?

Weed, Cocaine and Heroin: What it Means to Your Bank or Credit Union?

  • Speaker: Doug Keipper
  • Product ID: 705440
  • Duration: 60 Min
This webinar will focus on the today’s marketplace for weed, cocaine and opioids including heroin. It will cover topics such as FinCEN’s expectations regarding Marijuana-related businesses, drug enforcement agency fact sheets, FBI and DEA documentary on opioid abuse, summary review of transactions and much more.
CD/Recorded
$229
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Recorded/CD
BREXIT – What's Changing for Life Science Product License Holders/Manufacturers and What You Need to Do Right Now?

BREXIT – What's Changing for Life Science Product License Holders/Manufacturers and What You Need to Do Right Now?

  • Speaker: Robert J Russell
  • Product ID: 705811
  • Duration: 90 Min
This webinar will discuss how to accurately assess the impact of Brexit up on your operations and existing licensed life products in the UK and EU. How to plan to becoming compliant on “what is known” and how to be agile as the rest of implications become clearer. Impact on Filing Registrations with EMA in Q1 2019, How Will the UK’s Withdrawal Effect the Sunset Clause.
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