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Home › Online Training ›  Research & Development

Research and Development Training - Live Webinars, Recordings & CDs

ComplianceOnline's training programs for Research and Development professionals are designed to stimulate and manage innovation in the workplace. Improve the productivity of your R&D and foster excellence by learning concepts, methodologies, and the use of tools to strategically plan product development and to manage core competencies. Explore the courses developed by a multitude of experts for diverse, creative, intelligent, and independent R&D professionals.
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Recorded/CD
Pre-Market Submission Implications of FDA’s Human Factors Guidance and Device Priority List

Pre-Market Submission Implications of FDA’s Human Factors Guidance and Device Priority List

  • Speaker: Robert A North
  • Product ID: 704551
  • Duration: 90 Min
This training program will explore why human factors has become a vital part of the FDA’s medical device pre-market approval/clearance process. The FDA Center for Devices and Radiological Health (CDRH) recently issued two guidance documents on human factors that are key elements in determining pre-market submission strategies for manufacturers. In this webinar, attendees will learn how to provide clear and complete human factors submissions meeting the intent of these guidance.
CD/Recorded
$229
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Recorded/CD
Implementation of Rapid Microbial Methods for Air and Water Monitoring in Pharmaceutical Industry

Implementation of Rapid Microbial Methods for Air and Water Monitoring in Pharmaceutical Industry

  • Speaker: Igor Gorsky
  • Product ID: 704560
  • Duration: 2 hrs
This training program will dispel mistaken paradigms regarding the risk based approach to introduction of rapid microbial detection systems for water systems. Attendees will understand how to validate and transfer LIF method and how to validate LIF instrument against currently used methods.
CD/Recorded
$0
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Recorded/CD
Extractables and Leachables Testing for Polymeric Materials Used in Pharmaceutical Industry: An Introduction and Strategies in Current Practice

Extractables and Leachables Testing for Polymeric Materials Used in Pharmaceutical Industry: An Introduction and Strategies in Current Practice

  • Speaker: Armin Hauk
  • Product ID: 704340
  • Duration: 60 Min
This training program will offer participants an understanding of the concept of E&L (Extractables and Leachables) studies and about developing an E&L study in a reasonable and pragmatic way - based on regulatory requirements, guidelines and recommendations.
CD/Recorded
$169
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Recorded/CD
FDA Regulations on Usage of New Pharmaceutical Agents to Fight Infection

FDA Regulations on Usage of New Pharmaceutical Agents to Fight Infection

  • Speaker: Thomas Webster
  • Product ID: 704559
  • Duration: 2 hrs
This training program will discuss fundamentals of infection and the use of materials/drugs to fight infection, FDA regulatory approvals for drugs and materials used to fight infection, and future thoughts on approaches to fight infection.
CD/Recorded
$0
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Recorded/CD
Methods for Detecting Mycoplasma Contamination in the Manufacture of Pharmaceuticals and Biologics

Methods for Detecting Mycoplasma Contamination in the Manufacture of Pharmaceuticals and Biologics

  • Speaker: Michael Simonian
  • Product ID: 704185
  • Duration: 90 Min
This training program will help attendees understand the sources of mycoplasma contamination and how to minimize the occurrence of contamination. The regulatory standards for testing will be described as well as the methods of mycoplasma detection and the resources for testing. At the conclusion of this webinar, attendees will have knowledge of the importance of mycoplasma contamination testing and how to successfully perform the tests in their company’s setting.
CD/Recorded
$249
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Recorded/CD
Discussion of Revisions Contained in ISO 13485:2016

Discussion of Revisions Contained in ISO 13485:2016

  • Speaker: Edward Kimmelman
  • Product ID: 704506
  • Duration: 90 Min
The training program will prepare attendees to better understand the revisions to this standard as they read its requirements in detail. For those organizations that have a QMS that's compliant with ISO 13485:2003, you will benefit from this program as it will help you assess your preparations.
CD/Recorded
$169
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Recorded/CD
Educating and Training Staff to Manage Regulatory Records

Educating and Training Staff to Manage Regulatory Records

  • Speaker: Charlie Sodano
  • Product ID: 704493
  • Duration: 60 Min
This training program will explore why planning and implementing an information management solution can be a daunting task. Composing policies and procedures is a good start, followed by testing in small groups. But a lot of people are resistant to changing their work practices, especially if they have been working for an organization for a long time. The worst thing that can happen is that staff appears to be compliant with the new plan, but has found a way to continue their prior practices under the radar. The solution to this problem is a comprehensive initial and continuing educational plan.
CD/Recorded
$229
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Recorded/CD
FDA Inspection Preparedness

FDA Inspection Preparedness

  • Speaker: Susan Muhr Leister
  • Product ID: 704221
  • Duration: 60 Min
This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.
CD/Recorded
$229
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Recorded/CD
FDA’s New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

FDA’s New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

  • Speaker: Angela Dunston
  • Product ID: 704431
  • Duration: 90 Min
This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).
CD/Recorded
$179
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Recorded/CD
Using Analysis of Variance - A Practical Approach

Using Analysis of Variance - A Practical Approach

  • Speaker: Daniel O Leary
  • Product ID: 703824
  • Duration: 60 Min
This training program will illustrate the underlying idea that makes ANOVA work. It will also offer an understanding of the data collection issues you should plan and how to get access to ANOVA in Excel.
CD/Recorded
$229
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Recorded/CD
How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

  • Speaker: Michael Levin
  • Product ID: 704274
  • Duration: 60 Min
Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.
CD/Recorded
$229
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Recorded/CD
Making Sense of BSCs, Hoods, Isolators, RABs

Making Sense of BSCs, Hoods, Isolators, RABs

  • Speaker: Joseph Winslow
  • Product ID: 704361
  • Duration: 60 Min
Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.
CD/Recorded
$229
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Recorded/CD
Veterinary Drug Approval Process and FDA's Regulatory Oversight

Veterinary Drug Approval Process and FDA's Regulatory Oversight

  • Speaker: Karl M. Nobert
  • Product ID: 703971
  • Duration: 60 Min
This training program will provide attendees with an introduction to FDA’s veterinary drug approval process. It will also discuss key components of an appropriate animal field study needed to support new animal drug approval and explain how jurisdiction is split between various federal agencies in certain cases.
CD/Recorded
$0
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Recorded/CD
Maintaining a Sustainable and Compliant Design Validation System and Using FMEA for Device Manufacturers

Maintaining a Sustainable and Compliant Design Validation System and Using FMEA for Device Manufacturers

  • Speaker: David Dills
  • Product ID: 701074
  • Duration: 60 Min
This webinar will provide valuable assistance and guidance for medical device companies to ensure they have a well defined, deployed and enforceable design validation program. Did I make the right product and can I prove it is Design Validation! Device manufacturers need to establish and maintain procedures for validating the device design. Design validation has to be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation must ensure that the company’s device or devices conform to defined user needs and intended uses and will include testing of production units under actual or simulated use conditions.
CD/Recorded
$299
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Recorded/CD
Risk Management as applied to Design Control

Risk Management as applied to Design Control

  • Speaker: Nicolaas Besseling
  • Product ID: 701212
  • Duration: 60 Min
This Risk management training will guide you through how to integrate the elements of ISO14971 (Risk management for medical devices) in your design process.
CD/Recorded
$299
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Recorded/CD
Bringing Compliance to Design Control through Life Cycle Management of Older Medical Devices and Surgical Instruments

Bringing Compliance to Design Control through Life Cycle Management of Older Medical Devices and Surgical Instruments

  • Speaker: Rob Braido
  • Product ID: 701230
  • Duration: 60 Min
This Life cycle management training will provide valuable assistance and gives a process to product design history files and technical files up to date with the new standards through life cycle management.
CD/Recorded
$299
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Recorded/CD
Human Factors Standards and Guidance's for Medical Devices - which documents apply to my situation?

Human Factors Standards and Guidance's for Medical Devices - which documents apply to my situation?

  • Speaker: Robert A North
  • Product ID: 700861
  • Duration: 60 Min
This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device.
CD/Recorded
$299
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Recorded/CD
Key differences in Design Control Requirements between ISO13485:2003 and the FDA Quality System Regulation

Key differences in Design Control Requirements between ISO13485:2003 and the FDA Quality System Regulation

  • Speaker: Dennis Moore
  • Product ID: 700192
  • Duration: 60 Min
Detailed analyses of the sections of the QSR design control regulations that have requirements not present in the ISO 13485:2003 standard. Many companies are confidant that their ISO 13485:2003 design control system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 design control cites are written and warning Letters, seizures or worse ensue.
CD/Recorded
$249
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Recorded/CD
Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Risk Management

Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Risk Management

  • Speaker: Vinny Sastri
  • Product ID: 700537
  • Duration: 60 Min
This Failure Modes and Effects Analysis (FMEA) Webinar will give an overview and elements of an FMEA. The analysis of data outputs will also be discussed.
CD/Recorded
$249
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Recorded/CD
Design Controls Basics - From Design Inputs to Design Outputs and Effective Design Transfer

Design Controls Basics - From Design Inputs to Design Outputs and Effective Design Transfer

  • Speaker: Vinny Sastri
  • Product ID: 700536
  • Duration: 60 Min
This Design Controls Webinar will provide a overview of all the steps involved in design controls and explain and clarify and state specific requirements in the regulations.
CD/Recorded
$249
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