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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
Mobile Medical Applications for Devices: Trends, Bills and Guidance

Mobile Medical Applications for Devices: Trends, Bills and Guidance

  • Speaker: Kosta Makrodimitris
  • Product ID: 702459
  • Duration: 90 Min
This 90-minute webinar will help you understand the current landscape of the growing field of mobile medical applications and the current regulatory efforts to ensure that the related medical devices will not pose high risks for patient safety and promote innovations.
CD/Recorded
$229
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Recorded/CD
To Validate or Not To Validate: A Daily Question for the Pharmaceutical Scientist

To Validate or Not To Validate: A Daily Question for the Pharmaceutical Scientist

  • Speaker: Kim Huynh-Ba
  • Product ID: 702386
  • Duration: 90 Min
This 90-minute webinar will outline the common deficiencies in relation to method validation, for pharmaceutical products, outline regulatory requirements and the change control process needed to stay in compliance.
CD/Recorded
$0
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Recorded/CD
Biomarkers for Drug Development: The Emerging Regulatory Landscape

Biomarkers for Drug Development: The Emerging Regulatory Landscape

  • Speaker: Orest Hurko
  • Product ID: 702396
  • Duration: 60 Min
This training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.
CD/Recorded
$229
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Recorded/CD
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer

  • Speaker: Gregory Martin
  • Product ID: 702278
  • Duration: 120 Min
This 120-minute webinar on using the QbD Approach to Analytical Method Lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements.
CD/Recorded
$149
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Recorded/CD
Understanding Design Controls for Medical Devices

Understanding Design Controls for Medical Devices

  • Speaker: Jeff Kasoff
  • Product ID: 701285
  • Duration: 60 Min
This webinar will cover the basics of design controls for medical devices, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well.
CD/Recorded
$229
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Recorded/CD
Full Day Virtual Seminar: Reliability Engineering Fundamentals for Medical Devices

Full Day Virtual Seminar: Reliability Engineering Fundamentals for Medical Devices

  • Speaker: Dev Raheja
  • Product ID: 702054
  • Duration: 6 hrs
This 6-hr webinar on Reliability Engineering Fundamentals for Medical Devices will cover the science and techniques for designing highly reliable medical devices at lower cost and in lesser time.
CD/Recorded
$799
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Recorded/CD
4-hr Virtual Seminar: Design Reviews for Efficiency and Efficacy

4-hr Virtual Seminar: Design Reviews for Efficiency and Efficacy

  • Speaker: Dev Raheja
  • Product ID: 702028
  • Duration: 4 hrs
This 4 hour training will focus on best practices in design reviews and show how you can add high value to your products and processes by improving the performance while reducing the life cycle costs significantly.
CD/Recorded
$799
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Recorded/CD
Dry Powder Inhalers II: Enhancing bioavailability through product design

Dry Powder Inhalers II: Enhancing bioavailability through product design

  • Speaker: Claudio Cerati
  • Product ID: 702013
  • Duration: 85 Min
This webinar on Dry Powder Inhalers will focus on pharmaceutical active particle design, physical characteristics and its relationship with product behavior both in vitro and in vivo.
CD/Recorded
$499
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Recorded/CD
Product Risk Management under FDA and ISO 14971:2007

Product Risk Management under FDA and ISO 14971:2007

  • Speaker: John E Lincoln
  • Product ID: 701176
  • Duration: 60 Min
This Product risk management training/webinar for Medical devices will help in to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007. The US FDA is increasingly stating that many regulated activities should be “risk-based”. Major resource-consuming activities such as product and process / equipment / facility, and software validation, CAPA investigations, vendor audits can all be tailored to a risk based approach. This eliminates the current SOP-defined “one size fits all” approach, to a flexible, resource adjusted approach, less arbitrarily defined in an SOP, but yielding results targeted to real needs. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry. Then how to use this document to accomplish the above goals.
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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Recorded/CD
Viral Validation for Biopharmaceuticals

Viral Validation for Biopharmaceuticals

  • Speaker: Kathryn Martin Remington
  • Product ID: 700187
  • Duration: 60 Min
This Viral Validation webinar provide information on potential viral contaminants and their risks, expectations of regulatory agencies, effective methods of viral inactivation/removal, and important considerations in the design of a viral validation.
CD/Recorded
$249
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Recorded/CD
Risk Management Activities during Design Input

Risk Management Activities during Design Input

  • Speaker: Edwin L Bills
  • Product ID: 700526
  • Duration: 60 Min
Learn how to use tools such as Preliminary Hazard Analysis to eliminate expensive design changes that occur when problems are discovered during Design Verification and Design Validation. Risk Management Activities can lead to reduced cost and reduced time to market when conducted during the Design Input phase of product development. Learn how to use tools such as Preliminary Hazard Analysis to eliminate expensive design changes that occur when problems are discovered during Design Verification and Design Validation.
CD/Recorded
$149
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Recorded/CD
Common Problems and Mistakes in Method Validation in drug development process

Common Problems and Mistakes in Method Validation in drug development process

  • Speaker: Dr. Wise Blackman
  • Product ID: 700267
  • Duration: 60 Min
This Method Validation training in drug development process will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation. This web seminar will address frequently observed issues and problems with method validations.
CD/Recorded
$0
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Recorded/CD
How to set up a small-volume radiopharmaceuticals manufacturing facility

How to set up a small-volume radiopharmaceuticals manufacturing facility

  • Speaker: Shankar Seetharaman
  • Product ID: 700475
  • Duration: 60 Min
This Radiopharmaceuticals training will set out guidance and advice for those interested in setting up or improving an existing facility. Radiopharmaceutical manufacture is starting to begin a new phase as FDG now has a product licence
CD/Recorded
$249
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