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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
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
$0
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Recorded/CD
4-Hr Virtual Training: Key Factors to Write an Effective Standard Operating Procedure and Work Instructions

4-Hr Virtual Training: Key Factors to Write an Effective Standard Operating Procedure and Work Instructions

  • Speaker: Joy McElroy
  • Product ID: 704778
  • Duration: 4 hrs
This training program will guide attendees in writing effective Standard Operating Procedures and Work Instructions. It will also discuss how to assess and write to the audience and how to review and revise SOPs and Work Instructions.
CD/Recorded
$0
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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
$0
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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
$0
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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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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
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Recorded/CD
Risk Based Design Control

Risk Based Design Control

  • Speaker: Edwin Waldbusser
  • Product ID: 704548
  • Duration: 60 Min
This training program will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. The program will also help in getting projects completed on time and within budget.
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
$229
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Recorded/CD
3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 704356
  • Duration: 3 hrs
This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.
CD/Recorded
$429
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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
$229
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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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