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Home › Online Training ›Biotechnology Training ›  Biologics and Biosimilars

Biologics and Biosimilars Regulatory Compliance Training - Live Webinars, Recordings & CDs

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How to Conduct an ASTM E 2018 Compliant Property Condition Assessment
15
/ Oct
Monday-2018

How to Conduct an ASTM E 2018 Compliant Property Condition Assessment

  • Speaker: Keith Warwick
  • Product ID: 705369
  • Duration: 60 Min
Learn how to conduct a property condition assessment (PCA), schedule the field work, conduct the field work, and write the final report. The course will present techniques for developing cost estimates within a reasonable time frame. It will also discuss each of the components of ASTM E 2018 - 15 Standard Guide for Property Condition Assessments.
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Transfer of Analytical Methods According to the USP Chapter <1224>
15
/ Oct
Monday-2018

Transfer of Analytical Methods According to the USP Chapter <1224>

  • Speaker: Dr. Ludwig Huber
  • Product ID: 701971
  • Duration: 75 Min
This webinar will explain the final version of USP Chapter <1224> and FDA guidance for conducting and documenting method transfer between laboratories and sites, and provide tools for effective implementation.
* Per Attendee
$199
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Red Flags of Money Laundering
16
/ Oct
Tuesday-2018

Red Flags of Money Laundering

  • Speaker: William Schlameuss
  • Product ID: 703417
  • Duration: 60 Min
This webinar will explain what money laundering is, various types of money laundering including structuring, micro-structuring and cuckoo smurfing. Attendees will learn how to identify the red flags of money laundering in an account within your institution.
* Per Attendee
$199
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How to Deal with Toxic Behaviours in Healthcare to Improve Patient Safety and Team Performance
17
/ Oct
Wednesday-2018

How to Deal with Toxic Behaviours in Healthcare to Improve Patient Safety and Team Performance

  • Speaker: Mitchell Kusy
  • Product ID: 705840
  • Duration: 60 Min
In this Webinar you will learn how to find out toxic people those reduces patient safety, what is their modus operandi, and how to deal with them in terms of feedback, proactive and reactive strategies so that there is improvement of patient safety & team performance. How to spot such people and avoid hiring them.
* Per Attendee
$149
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Outlook: It's Time to Get Organized
17
/ Oct
Wednesday-2018

Outlook: It's Time to Get Organized

  • Speaker: Mike Thomas
  • Product ID: 705589
  • Duration: 60 Min
In this session you'll learn how, used in the right way, Outlook can save you time, help you to gain more control, improve your response time and allow you to keep up with the never-ending stream of critical actions and due dates!
* Per Attendee
$149
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OTC Drug Regulations
17
/ Oct
Wednesday-2018

OTC Drug Regulations

  • Speaker: Loren Gelber
  • Product ID: 705446
  • Duration: 60 Min
This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.
* Per Attendee
$229
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Fair Debt Collection Practices Act - FDCPA, FCRA, Easily-Broken HIPAA, Civil Liability, Bad Check Laws, Promissory Notes, Mini-Miranda Warning
17
/ Oct
Wednesday-2018

Fair Debt Collection Practices Act - FDCPA, FCRA, Easily-Broken HIPAA, Civil Liability, Bad Check Laws, Promissory Notes, Mini-Miranda Warning

  • Speaker: David Sanders
  • Product ID: 704686
  • Duration: 90 Min
In this fast-paced and informative training program, attendees will learn exactly what violates the Fair Debt Collection Practices Act (FDCPA) and other laws that lead to costly fines and judgments. The program will also overview consumer vs. commercial bankruptcy and the differences between Chapter 7, 11 and 13.
* Per Attendee
$199
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Accounts Payable Fraud - Detecting and Preventing AP Fraud
17
/ Oct
Wednesday-2018

Accounts Payable Fraud - Detecting and Preventing AP Fraud

  • Speaker: Peter Goldmann
  • Product ID: 702441
  • Duration: 100 Min
This webinar will guide you through the critical steps in ensuring strong controls for the accounts payable (AP) function and provide practical 'how to' guidance for minimizing your organization’s exposure to AP fraudsters.
* Per Attendee
$199
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Establishing a Medical Device Security Program
18
/ Oct
Thursday-2018

Establishing a Medical Device Security Program

  • Speaker: Robert Mai
  • Product ID: 705841
  • Duration: 60 Min
In this medical devices security webinar you will learn how to establish a Product Security Program that help your organization to put the right people, processes, and technology in one place to solve the changing landscape of connected medical devices and the risks that are associated with the new environment. It will also highlight the medical device security leading best practices the industry has been implementing to not only meet regulatory requirements but also increasing customer’s needs.
* Per Attendee
$199
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ICD-10-CM Official Guidelines for Coding and Reporting - FY 2019
18
/ Oct
Thursday-2018

ICD-10-CM Official Guidelines for Coding and Reporting - FY 2019

  • Speaker: Pamela Joslin
  • Product ID: 705826
  • Duration: 60 Min
This webinar will discuss overviews of each of the four sections of 2019 ICD-10-CM Guidelines for Coding and Reporting. These are the guidelines that payers use when processing your claims. It will teach how accurate ICD-10 reporting ties to patient encounter, reimbursement and reporting, how to use chapter 7, how to use the A, D, S & documentation requirements. Expert will give examples of commonly used guidelines, such as sequencing, code first, code also, etiology and manifestation.
* Per Attendee
$199
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Medical Devices: Navigating FDA Requirements for Non-US Organizations
18
/ Oct
Thursday-2018

Medical Devices: Navigating FDA Requirements for Non-US Organizations

  • Speaker: Jonathan Lee
  • Product ID: 705823
  • Duration: 90 Min
This webinar will give an understanding of various processes and compliance requirements for US market entry by non-US medical device manufacturer. It will teach how to comply with pre-market requirements, how to get submission & product clearance/approval, what are various activities to be done post market entry of products (surveillance, reporting, audit, correction & removal).
* Per Attendee
$199
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Payment System Policy: FFIEC, Risk Management and Fraud Control
18
/ Oct
Thursday-2018

Payment System Policy: FFIEC, Risk Management and Fraud Control

  • Speaker: Ray Graber
  • Product ID: 705810
  • Duration: 90 Min
This webinar is designed to provide understanding of payment system risk policy, how to do risk assessment and mitigate risk, what can be an optimal organizational structure to manage payment strategy.
* Per Attendee
$159
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The U.S. Food and Drug Administration’s Regulation of Pet Food: Complying with FDA’s Rules for the Marketing and Sale of Dog and Cat Food
18
/ Oct
Thursday-2018

The U.S. Food and Drug Administration’s Regulation of Pet Food: Complying with FDA’s Rules for the Marketing and Sale of Dog and Cat Food

  • Speaker: Karl M. Nobert
  • Product ID: 702224
  • Duration: 90 Min
This webinar will provide an introduction to FDA rules governing manufacturing, testing, labeling and marketing of pet food in the U.S. In addition to facility inspections and product recalls, the webinar will summarize and assess FDA’s enforcement activity in the U.S. pet food market paying particular attention to enforcement trends and risks.
* Per Attendee
$199
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4-Hr Virtual Training: Introduction to Design of Experiments
18
/ Oct
Thursday-2018

4-Hr Virtual Training: Introduction to Design of Experiments

  • Speaker: Steven Wachs
  • Product ID: 704847
  • Duration: 4 hrs
In this training program, attendees will understand when and why to apply DOE (design of experiments). They will also learn to identify and interpret significant factor effects and 2-factor interactions and develop predictive models to explain and optimize process/product behavior. Applying efficient fractional factorial designs in screening experiments will also be discussed.
* Per Attendee
$399
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"Front-End, Middle, and Back-End" Approach to Credit Management
19
/ Oct
Friday-2018

"Front-End, Middle, and Back-End" Approach to Credit Management

  • Speaker: David L Osburn
  • Product ID: 705808
  • Duration: 60 Min
This credit management webinar will discuss the credit analysis process, how to do financial statement analysis and how to do effective cash management using various tools and techniques and how to use various collection techniques (manage legal issues and using negotiation skills) and overall how to manage the collection process.
* Per Attendee
$169
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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
Successful Water System Sanitization

Successful Water System Sanitization

  • Speaker: T.C Soli
  • Product ID: 705825
  • Duration: 60 Min
This webinar will discuss common problems of sanitization process, the causes of sanitization failures and teach how to troubleshoot and take remedial actions with respect to material, construction methods, biofilm removal process and timing of sanitization.
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Recorded/CD
How To Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities

How To Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities

  • Speaker: Javier Kuong
  • Product ID: 700095
  • Duration: 120 Min
This training will provide valuable knowledge on what companies need to do to establish an "effective" Compliance Office that leads to conceiving, developing and implementing successful GRC programs and provides top level coordinating leadership for governance, risk management and compliance issues across the enterprise.
CD/Recorded
$249
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Recorded/CD
The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016

The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016

  • Speaker: John E Lincoln
  • Product ID: 705111
  • Duration: 90 Min
This webinar will focus on the IEC standard and its key requirements: “IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices”. It will touch on “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”. Another webinar will focus on Part 2, and re-evaluate key portions of Part-1.
CD/Recorded
$249
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