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Home › Online Training ›  Biotechnology Training

Biotech Regulatory Compliance Training - Live Webinars, Recordings & CDs

Sub Categories: Testing and Validation | Documentation and IT | Contamination Control | Quality & Safety | Technologies and Processes | Blood and Blood Products | Tissue and Tissue Products | Cellular and Gene Therapy | Biologics and Biosimilars | Regulations & Guidances
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Building a World Class Accounts Payable Operation: P2P, AP
19
/ Oct
Friday-2018

Building a World Class Accounts Payable Operation: P2P, AP

  • Speaker: Brian G Rosenberg
  • Product ID: 703979
  • Duration: 60 Min
This training program will help attendees examine if their AP department matches world-class standards. Attendees will learn key success factors to an optimal accounts payable operation. They will also gain in depth knowledge on the must-have technologies for any AP operation and learn how to design processes to fully leverage those capabilities. The webinar will also discuss balancing controls with efficiency and how to create a fraud-proof department. Attendees will learn about the most important metrics for any AP department and how to develop strategies to improve those metrics.
* Per Attendee
$179
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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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BREXIT – What's Changing for Life Science Product License Holders/Manufacturers and What You Need to Do Right Now?
23
/ Oct
Tuesday-2018

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.
* Per Attendee
$199
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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.
* Per Attendee
$299
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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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Fishbone Diagramming
23
/ Oct
Tuesday-2018

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.
* Per Attendee
$179
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Weed, Cocaine and Heroin: What it Means to Your Bank or Credit Union?
23
/ Oct
Tuesday-2018

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.
* 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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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
Safe Use of Ladders and Proper Climbing Practices; Fall Protection on Aerial Lifts; Proper Use of Staging

Safe Use of Ladders and Proper Climbing Practices; Fall Protection on Aerial Lifts; Proper Use of Staging

  • Speaker: John J Meola
  • Product ID: 705493
  • Duration: 90 Min
This webinar will review the best practices associated with use of ladders of all types, including the selection, inspection, storage and transport of ladders, along with safe practice when erecting, climbing, working from and descending a ladder. It will also discuss the process and practices related with aerial lifts and working from buckets on an extended boom.
CD/Recorded
$179
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Recorded/CD
Proposed NACHA Operating Rules - Hear the Latest NEWS in the Rules Space

Proposed NACHA Operating Rules - Hear the Latest NEWS in the Rules Space

  • Speaker: Donna K Olheiser
  • Product ID: 705835
  • Duration: 60 Min
This NACHA Operating Rules training session will provide the details on the proposed changes that potentially may be happening in the future. How it is going to impact you and what can you do about it.
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Recorded/CD
How to Effectively Manage a Construction Project

How to Effectively Manage a Construction Project

  • Speaker: Keith Warwick
  • Product ID: 704858
  • Duration: 90 Min
This webinar training will explain the process to effectively manage construction projects. The Instructor will discuss reviews of plans and specification, inspection program, order of operations, identification of hazards and safety controls.
CD/Recorded
$199
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