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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
Selection and Management of Contract Vendors

Selection and Management of Contract Vendors

  • Speaker: Peggy Berry
  • Product ID: 704884
  • Duration: 90 Min
This webinar will discuss approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.
CD/Recorded
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Recorded/CD
Device Design and Risk Management

Device Design and Risk Management

  • Speaker: Daniel O Leary
  • Product ID: 704561
  • Duration: 90 Min
As medical device requirements and expectations increase, coupled with strengthened standards, the design project must seek every opportunity to leverage activities in the area to satisfy requirements in other areas. This reduces the total work and helps make these processes more efficient. By attending this presentation, you will learn techniques to improve your device design project.
CD/Recorded
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Recorded/CD
Prove 21 CFR 820 Compliance Using Requirements Traceability

Prove 21 CFR 820 Compliance Using Requirements Traceability

  • Speaker: Russell Pizzuto
  • Product ID: 704935
  • Duration: 90 Min
This webinar will demonstrate how to use requirements tractability to systematically connect Engineering, Manufacturing and Risk Management processes, and how to systematically collect the objective evidence necessary to prove 21 CFR 820 compliance to the FDA.
CD/Recorded
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Recorded/CD
Critical Elements of Quality Risk Management Relating to FDA Compliance

Critical Elements of Quality Risk Management Relating to FDA Compliance

  • Speaker: Danielle DeLucy
  • Product ID: 704829
  • Duration: 60 Min
This training program will discuss risk management and outline the requirements for applying risk management to the quality system. It will also discuss how to conduct and implement risk management practices at your firm and review communication techniques to highlight the benefits of risk management.
CD/Recorded
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Recorded/CD
4-hr Virtual Seminar: The Quality Manual Ensuring Regulatory Requirements

4-hr Virtual Seminar: The Quality Manual Ensuring Regulatory Requirements

  • Speaker: Howard Cooper
  • Product ID: 704915
  • Duration: 4 hrs
This 4-hr webinar will focus on product lifecycle concepts that are applicable to all of the FDA regulated industries. Learn the objectives, purpose and scope of the quality manual and how to can be adapted to each different business environment.
CD/Recorded
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Recorded/CD
Integrating ISO 14971 Risk Analysis into the Product Development Process

Integrating ISO 14971 Risk Analysis into the Product Development Process

  • Speaker: Russell Pizzuto
  • Product ID: 704926
  • Duration: 90 Min
This Webinar will present the best practices for integrating medical device risk analysis into a quality system. This integrated processes spans new product development, design change, production, and post market surveillance for the lifecycle of the device. Objective evidence produced by the integrated processes can be used to demonstrate risk analysis compliance to 21 CFR 820 and ISO 14971 during an audit.
CD/Recorded
$249
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Recorded/CD
Type 2 DMFs for Active Pharmaceutical Ingredients (APIs)

Type 2 DMFs for Active Pharmaceutical Ingredients (APIs)

  • Speaker: Peggy Berry
  • Product ID: 704882
  • Duration: 90 Min
This webinar will discuss approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in the Drug Master File – in support of Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.
CD/Recorded
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Recorded/CD
USP Hot Topics: What's Hot Now and How to Track Coming Changes and Influence USP

USP Hot Topics: What's Hot Now and How to Track Coming Changes and Influence USP

  • Speaker: Gregory Martin
  • Product ID: 703521
  • Duration: 90 Min
This webinar will provide insight into some of the hottest topics at USP which will have the greatest impact on pharmaceutical laboratories. It will provide a comprehensive overview of the major changes in the USP that have been proposed or implemented in the last year and describe strategies for keeping abreast of coming changes and how you can influence them.
CD/Recorded
$249
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Recorded/CD
Creating the ISO 14971:2007: Developing the Risk Management File

Creating the ISO 14971:2007: Developing the Risk Management File

  • Speaker: Daniel O Leary
  • Product ID: 704855
  • Duration: 90 Min
This presentation gives you the essential information you need to write a successful plan. Many companies try to implement Risk Management using an inadequate Risk Management Plan. They often leave out required items or add additional, but unnecessary information. The Risk Management Plan is key to an efficacious project to ensure your device is safe and meets the regulatory requirements.
CD/Recorded
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Recorded/CD
Learning Design Controls through review of FDA 483 Observations

Learning Design Controls through review of FDA 483 Observations

  • Speaker: Mercedes Massana
  • Product ID: 704805
  • Duration: 75 Min
This webinar will provide participants with key knowledge of medical device design controls by analyzing FDA 483 observations and learning what the agency is looking for with respect to each design control element.
CD/Recorded
$229
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Recorded/CD
FDA Regulation, 3D Printing and Medical Devices

FDA Regulation, 3D Printing and Medical Devices

  • Speaker: Rachelle D Souza
  • Product ID: 704846
  • Duration: 75 Min
This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices.
CD/Recorded
$229
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Recorded/CD
Extractables and Leachables - Biopharma Polymeric Devices

Extractables and Leachables - Biopharma Polymeric Devices

  • Speaker: Mark Trotter
  • Product ID: 704798
  • Duration: 90 Min
This webinar training will examine the key topics concerning the use of polymeric single-use products in biopharm processes. It will offer a basic understanding of industry standards and regulatory compliance. The training program is designed for the experienced as well as those new to biopharmaceutical processes and need to know current requirements for determination of extractables and leachables in biopharm processes.
CD/Recorded
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Recorded/CD
Comparing the Pharmaceutical and Medical Device Product Lifecycles

Comparing the Pharmaceutical and Medical Device Product Lifecycles

  • Speaker: Howard Cooper
  • Product ID: 704853
  • Duration: 120 Min
This webinar will help you gain a greater understanding of regulatory and compliance requirements and how the early product lifecycle requirements establish the basic groundwork as a foundation from product development to commercialization continuing to out commercialization and product discontinuation.
CD/Recorded
$249
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Recorded/CD
Lyophilization: What you Need to Know, Validation and Regulatory Approaches

Lyophilization: What you Need to Know, Validation and Regulatory Approaches

  • Speaker: John R Godshalk
  • Product ID: 704845
  • Duration: 60 Min
In this webinar, attendees will learn how lyophilization cycles are developed, how lyophilizers work and how they are controlled and what is important to FDA and other regulatory bodies in the inspection of lyophilizers and in the validation process.
CD/Recorded
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Recorded/CD
Sterilizing Grade and Prefilter

Sterilizing Grade and Prefilter

  • Speaker: Mark Trotter
  • Product ID: 704703
  • Duration: 90 Min
This training program will review the latest industry filtration technologies and standards with an overview of regulatory requirements. It will also discuss why and how to determine which filter, the media, and pore ratings that are appropriate for various filtration applications. The program is designed for experienced as well as those new to biopharmaceutical processes. The need-to-know current requirements for specifying sterilizing grade and prefilters in biopharm processes will also be discussed.
CD/Recorded
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Recorded/CD
CDISC Cloud Computing in the Pharmaceutical Industry: Paradigm Shift in Project Management, Analysis and Validation

CDISC Cloud Computing in the Pharmaceutical Industry: Paradigm Shift in Project Management, Analysis and Validation

  • Speaker: Sunil Gupta
  • Product ID: 704674
  • Duration: 75 Min
This training program will help you better manage projects and offer practical tools to understand data content and quality. Attendees will learn to apply validation methods to reduce time to validate clinical summary tables. Attendees will also learn to apply advanced SAS programming techniques to standardize and automate the validation process.
CD/Recorded
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Recorded/CD
Biomarkers in Drug Development

Biomarkers in Drug Development

  • Speaker: Juan Leal
  • Product ID: 704068
  • Duration: 60 Min
This webinar will help attendees obtain the fundamentals of the science, clinical operations and clinical regulatory aspects of biomarker(s) identification, validation and application in clinical trials.
CD/Recorded
$229
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Recorded/CD
Combination Products - The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products

Combination Products - The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products

  • Speaker: Angela Dunston
  • Product ID: 704623
  • Duration: 120 Min
This training program will analyze the general considerations for cGMP compliance and review the cGMP requirements in 21 CFR 4.4(b). The program will also discuss applications of cGMP requirements for specific types of combination products.
CD/Recorded
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Recorded/CD
Single-Use Systems and Technologies

Single-Use Systems and Technologies

  • Speaker: Mark Trotter
  • Product ID: 704609
  • Duration: 90 Min
This training program will examine the many facets of disposable bioprocessing systems that incorporate a wide scope of polymeric single-use products. Single-use disposable technologies, from upstream to downstream processes, will be reviewed as related to the use of polymeric devices. Specific attention will be given to the related applications used in the production of biopharmaceuticals and pharmaceuticals.
CD/Recorded
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Recorded/CD
Technology Transfer and Validation for Medical Devices and Pharmaceuticals: The Link between Development, Validation and Commercial Production

Technology Transfer and Validation for Medical Devices and Pharmaceuticals: The Link between Development, Validation and Commercial Production

  • Speaker: Carlos Rodriguez Garcia
  • Product ID: 704248
  • Duration: 60 Min
The parallel requirements for medical devices and pharmaceuticals are incorporated into this comprehensive webinar that delineates the foundation for technology transfer and validation, encompassing regulatory requirements and voluntary guidance.
CD/Recorded
$279
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