ComplianceOnline

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.

Recorded/CD
How to Establish and Maintain a Design History File for a Medical Device

How to Establish and Maintain a Design History File for a Medical Device

  • Speaker: Mary Nunnally
  • Product ID: 705287
  • Duration: 60 Min
This device compliance training will offer a basic understanding of the records required to fulfill requirements of both US FDA 21 CFR 820 and ISO 13485:2016 for establishment and maintenance of a Design History File (DHF). It will also help attendees understand what document control means for DHF records.
CD/Recorded
$229
Recorded/CD
Using Open Access - Finding Trustworthy Online Resources

Using Open Access - Finding Trustworthy Online Resources

  • Speaker: Anne E Maczulak
  • Product ID: 705322
  • Duration: 90 Min
This webinar will focus on most trustworthy open access resources. It will also provide tips on how to gain access to hard-to-find materials by paying high subscription or membership fees.
CD/Recorded
$0
Recorded/CD
Three Ways Home Healthcare is Changing the Medical Device Game

Three Ways Home Healthcare is Changing the Medical Device Game

  • Speaker: Tom Kramer
  • Product ID: 705228
  • Duration: 60 Min
This medical device training program will provide an understanding of creative methodologies to solve design and development challenges of connected solutions for patient monitoring, scheduling, tracking, or drug delivery. It will demonstrate how consumer technologies vary by level of complexity and how they can be used in healthcare.
CD/Recorded
$0
Recorded/CD
Vendor Qualification for Quality Services

Vendor Qualification for Quality Services

  • Speaker: Todd Graham
  • Product ID: 705285
  • Duration: 60 Min
This webinar will teach you how and when to implement complimentary activities to an outsourced quality function and how to integrate this information into a fully-functioning program.
CD/Recorded
$0
Recorded/CD
Bio-Relevant Drug Dissolution Testing: A New Simple and Practical Approach

Bio-Relevant Drug Dissolution Testing: A New Simple and Practical Approach

  • Speaker: Saeed Qureshi
  • Product ID: 705256
  • Duration: 120 Min
This training program will highlight the current difficulties in conducting the dissolution tests, and then providing a simple and practical solution so that products could be evaluated appropriately and efficiently.
CD/Recorded
$279
Recorded/CD
Medical Device vs. Consumer Device: Leveraging Technology to Help Patients and Caregivers

Medical Device vs. Consumer Device: Leveraging Technology to Help Patients and Caregivers

  • Speaker: Tom Kramer
  • Product ID: 705223
  • Duration: 60 Min
This training program will provide an understanding of key areas of design focus for medical wearables. Attendees will learn best practices to implement product development plan that apply to medical devices.
CD/Recorded
$0
Recorded/CD
Preparing Stability Protocols for Development and Commercial Products

Preparing Stability Protocols for Development and Commercial Products

  • Speaker: Peggy Berry
  • Product ID: 704459
  • Duration: 90 Min
This training program will discuss the requirements of ICH and the FDA for stability protocol content and format, including special stability studies required for approval.
CD/Recorded
$279
Recorded/CD
Linear Regression Analysis for Medical Device Manufacturing

Linear Regression Analysis for Medical Device Manufacturing

  • Speaker: Daniel O Leary
  • Product ID: 705108
  • Duration: 90 Min
Analyzing processes to understand their operation and implementing improvement is a necessary element in any quality system, but is especially important in medical devices. One of the more important tools is linear regression. Using Excel, you can get the information you need for process improvement.
CD/Recorded
$0
Recorded/CD
Quality Control for Microbiological Media and Reagents

Quality Control for Microbiological Media and Reagents

  • Speaker: Todd Graham
  • Product ID: 705060
  • Duration: 60 Min
This webinar will give you the tools you need to maintain a quality supply of media and reagents in a variety of microbiology laboratories. A thorough understanding of the variety of challenges necessary in maintain quality media and reagents will be brought to the fore. This will allow you to perform microbiology testing with confidence.
CD/Recorded
$169
Recorded/CD
Strategies to Conduct a Successful Method Transfer according to FDA Expectations

Strategies to Conduct a Successful Method Transfer according to FDA Expectations

  • Speaker: Kim Huynh-Ba
  • Product ID: 705059
  • Duration: 90 Min
This webinar discusses how to execute meaningful Method Transfers by selecting appropriate analytical performance characteristics and acceptance criteria, documentation of the transfer process and how to avoid failures.
CD/Recorded
$0
Recorded/CD
Implementing a Modern Pharmaceutical Quality System

Implementing a Modern Pharmaceutical Quality System

  • Speaker: Steven Laurenz
  • Product ID: 705055
  • Duration: 60 Min
This presentation explores the basic concepts making up an ICH Q10 Quality System approach and steps to properly implement the concepts.
CD/Recorded
$0
Recorded/CD
Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

  • Speaker: Henry Urbach
  • Product ID: 705072
  • Duration: 90 Min
This webinar you will discuss how to help your organization get a better handle on what is an “objectionable microorganism, ” exactly how “objectionable” it really is and what you can do to minimize the risk if you find one in your process or product.
CD/Recorded
$249
Recorded/CD
Risk-based Approach to Biopharmaceutical Method Transfers

Risk-based Approach to Biopharmaceutical Method Transfers

  • Speaker: Jeffrey Staecker
  • Product ID: 705049
  • Duration: 60 Min
This Webinar will discuss how non-compendial biopharmaceutical analytical method transfers can leverage a risk-based approach to address Quality and Regulator concerns. Method transfers using a statistical equivalence approach with tight criteria as frequently suggested by regulators makes it difficult to transfer methods and can result in a high transfer failure rate.
CD/Recorded
$0
Recorded/CD
Compliance with Brexit's Impact on the Global Pharmaceutical industry

Compliance with Brexit's Impact on the Global Pharmaceutical industry

  • Speaker: Laura Brown
  • Product ID: 705047
  • Duration: 60 Min
Pharmaceutical companies will need to develop strategies for their drug programmes to deal with Brexit. This webinar will provide an essential understanding to help develop a strategy for managing Brexit.
CD/Recorded
$0
Recorded/CD
Quality by Design

Quality by Design

  • Speaker: Heath Rushing
  • Product ID: 705051
  • Duration: 60 Min
This training program will guide attendees in implementing QbD principles from discovery through product discontinuation. It will also illustrate applying statistics to set specifications and validate measurement systems (assays) and discuss utilizing risk management tools to identify and prioritize potential critical process parameters.
CD/Recorded
$0
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
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
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
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
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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