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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
Reimbursement Requirements for Designing Innovative Devices

Reimbursement Requirements for Designing Innovative Devices

  • Speaker: Tom Kramer
  • Product ID: 704625
  • Duration: 60 Min
This training program will highlight key metrics needed to convince reimbursement panels of design compliance and discuss how best to implement practices in your development process that ensure acceptance by reimbursement groups.
CD/Recorded
$0
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Recorded/CD
Perceptions of The Health Risks of Cosmetics, and What it means to Their Regulation

Perceptions of The Health Risks of Cosmetics, and What it means to Their Regulation

  • Speaker: Rob Ross Fichtner
  • Product ID: 704955
  • Duration: 90 Min
This webinar will discuss some of the major issues in the regulation of cosmetics. Upon completion of the session attendees will learn how regulators regulate cosmetics compared to other categories, fine line between cosmetics and drugs, and future directions for cosmetic regulations.
CD/Recorded
$179
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Recorded/CD
Project Risk Management

Project Risk Management

  • Speaker: Mario Mosse
  • Product ID: 705015
  • Duration: 90 Min
Project risk management includes the processes of conducting risk management planning, identification, analysis, action planning, and controlling risk on a project. This training program will analyze the objectives of project risk management - to increase the likelihood and impact of positive outcomes while decreasing the likelihood and impact of negative events affecting the success of the project.
CD/Recorded
$229
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Recorded/CD
Project Management Essentials: The 8 Keys to Successfully Completing Every Project On-Time and On Budget

Project Management Essentials: The 8 Keys to Successfully Completing Every Project On-Time and On Budget

  • Speaker: Christopher R DeVany
  • Product ID: 705013
  • Duration: 90 Min
This training program will help attendees grasp the essentials of project management and plan effectively for identifying project needs. It will also discuss practices for keeping content, process, and structure on track to produce positive outcomes.
CD/Recorded
$0
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Recorded/CD
The 21 Elements of a 510(k)

The 21 Elements of a 510(k)

  • Speaker: John E Lincoln
  • Product ID: 702323
  • Duration: 90 Min
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product requirements and documentation necessary to file a 510(k). The 510(k), in any of its three allowable formats, with up to 21 required elements. A brief discussion of how to address device changes and when to file a new 510(k). Consideration of the U.S. FDA's current K-97-1 Memo / guidance document on 510(k) Device Modifications: Deciding When to submit a 510(k) for a Change to an Existing Device, to provide tools to document such decisions.
CD/Recorded
$279
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Recorded/CD
Creating a Good Design History File (DHF) for Audit Success

Creating a Good Design History File (DHF) for Audit Success

  • Speaker: Mercedes Massana
  • Product ID: 701978
  • Duration: 60 Min
This DHF regulatory compliance training will discuss the structure of a good Design History File, elements to look for when auditing a DHF and how to address issues. It will provide the information necessary to maintain a good DHF that will help manufacturers during a regulatory compliance audit.
CD/Recorded
$279
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Recorded/CD
Equipment Qualification Basics

Equipment Qualification Basics

  • Speaker: Joy McElroy
  • Product ID: 704403
  • Duration: 90 Min
This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.
CD/Recorded
$249
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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
$0
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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
$0
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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
$0
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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
$0
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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
$0
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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
$0
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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
$0
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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
$0
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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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