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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
Pediatric Drug Development - Relevant FDA Laws and Changing Approach

Pediatric Drug Development - Relevant FDA Laws and Changing Approach

  • Speaker: Robert L Kunka
  • Product ID: 703567
  • Duration: 60 Min
This webinar on pediatric drug development will discuss relevant laws and FDA's approach to pharmaceutical and clinical development in pediatric patients.
CD/Recorded
$229
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Recorded/CD
Qualification Sample Size and Statistical Confidence for Pharma Process Performance Qualification (PPQ)

Qualification Sample Size and Statistical Confidence for Pharma Process Performance Qualification (PPQ)

  • Speaker: Marvin Iglehart
  • Product ID: 703579
  • Duration: 90 Min
This webinar will discuss the requirements and general expectations for Stage 2 – Process Qualification, the key concepts that lead to the basis of confidence level and/or statistical confidence and how to apply the concepts in practical use for validation, including acceptance criterion.
CD/Recorded
$229
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Recorded/CD
Quality System Development: Strength, Compliance and Efficiency through Value Stream Mapping

Quality System Development: Strength, Compliance and Efficiency through Value Stream Mapping

  • Speaker: Philip Russ
  • Product ID: 703490
  • Duration: 60 Min
This webinar will explain the principles of lean and value stream mapping. Attendees will learn how to apply lean concepts to continuous improvement work across the quality system.
CD/Recorded
$229
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Recorded/CD
Batch Production Record (BPR) and Device History Record (DHR) Review and Quality Assessment

Batch Production Record (BPR) and Device History Record (DHR) Review and Quality Assessment

  • Speaker: Jerry Dalfors
  • Product ID: 703560
  • Duration: 90 Min
This webinar will provide the typical elements required to be included in the Batch Production Record and the Device History Record in order to accomplish a quality and cost effective review and quality assessment based on current regulatory expectations.
CD/Recorded
$229
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Recorded/CD
Steps to Design and Develop an Effective Closed Loop Change Control System

Steps to Design and Develop an Effective Closed Loop Change Control System

  • Speaker: Michael Kagan
  • Product ID: 703489
  • Duration: 90 Min
This webinar will discuss how to design an effective change control system – electronic as well as paper-based – with traceability and closed loop verification built into the process.
CD/Recorded
$229
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Recorded/CD
Understanding CFR Part 210-211 Requirements for Drug Products

Understanding CFR Part 210-211 Requirements for Drug Products

  • Speaker: Jamie Jamshidi
  • Product ID: 700931
  • Duration: 90 Min
This webinar will discuss in detail all parts of the regulations set forth in part 210 and in parts 211 of 21 CFR chapters. Attendees will learn how to comply with these regulations.
CD/Recorded
$229
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Recorded/CD
The Use and Mis-use of FMEA in Medical Device Risk Management

The Use and Mis-use of FMEA in Medical Device Risk Management

  • Speaker: Edwin L Bills
  • Product ID: 700621
  • Duration: 60 Min
The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process. Most medical device manufacturers use FMEA as a part of their risk management system. Most medical device manufacturers use FMEA as a part of their risk management system.
CD/Recorded
$149
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Recorded/CD
Regulatory Records Primer: Decoding the Requirements for Medical Device and Pharmaceutical Manufacturers

Regulatory Records Primer: Decoding the Requirements for Medical Device and Pharmaceutical Manufacturers

  • Speaker: Les Schnoll
  • Product ID: 703433
  • Duration: 90 Min
This webinar will explain FDA regulatory records requirements for medical devices and finished pharmaceuticals. It will cover statutory requirement, required content, format, purpose, retention, and structure for regulatory records for both medical devices and pharmaceuticals.
CD/Recorded
$50
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Recorded/CD
Supplier Quality Management: Implement it Now or Pay for it Later

Supplier Quality Management: Implement it Now or Pay for it Later

  • Speaker: Les Schnoll
  • Product ID: 703357
  • Duration: 90 Min
This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.
CD/Recorded
$229
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Recorded/CD
Are you prepared for a regulatory audit from FDA or any other regulatory body?

Are you prepared for a regulatory audit from FDA or any other regulatory body?

  • Speaker: Philip Russ
  • Product ID: 703355
  • Duration: 90 Min
This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.
CD/Recorded
$229
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Recorded/CD
How To Translate Academic and Discovery Assays Into GLP Compliant Assays

How To Translate Academic and Discovery Assays Into GLP Compliant Assays

  • Speaker: Todd Graham
  • Product ID: 703275
  • Duration: 60 Min
This GLP compliant assay training will help attendees deal with the challenges and pitfalls that may occur when translating assays as demonstrated in the scientific literature or through internal discovery efforts.
CD/Recorded
$229
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Recorded/CD
Driving Quality and Compliance in Drug Development Through the FDA End-of-Phase 2A Meeting

Driving Quality and Compliance in Drug Development Through the FDA End-of-Phase 2A Meeting

  • Speaker: Roger Toothaker
  • Product ID: 703214
  • Duration: 60 Min
This training on FDA compliance will provide the attendees with an understanding of FDA expectations regarding end-of-phase 2A meeting guidance. Attendees will learn the best practices to comply with the intent of the guidance and to achieve a higher quality outcome from the meeting.
CD/Recorded
$229
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Recorded/CD
Drug Master Files: New Requirements under GDUFA

Drug Master Files: New Requirements under GDUFA

  • Speaker: Camille Davis Thornton
  • Product ID: 703209
  • Duration: 60 Min
This training on Generic Drug User Fee Amendments of 2012 will discuss the new requirements under GDUFA and effect of GDUFA on the Drug Master File (DMF) process.
CD/Recorded
$229
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Recorded/CD
FDA's Oversight of Mobile Medical Applications (''apps'') for Use on Smartphones and Similar Mobile Devices

FDA's Oversight of Mobile Medical Applications (''apps'') for Use on Smartphones and Similar Mobile Devices

  • Speaker: Karl M. Nobert
  • Product ID: 702270
  • Duration: 90 Min
This training on FDA regulation of mobile medical applications is designed to provide attendees with an overview of the U.S. Food and Drug Administration's oversight of certain medical and healthcare mobile medical applications ("apps") designed for use on smartphones and other mobile computing devices. Attendees will learn to distinguish between those apps requiring FDA review and those not subject to regulatory oversight.
CD/Recorded
$229
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Recorded/CD
Writing your Company's Safety Plan: I2P2 (Illness and Injury Prevention Plans) - What you Need to Know and Do

Writing your Company's Safety Plan: I2P2 (Illness and Injury Prevention Plans) - What you Need to Know and Do

  • Speaker: Don Dressler
  • Product ID: 702464
  • Duration: 60 Min
This webinar will be a basic, nuts and bolts program leading participants through the process of creating a written safety plan for evacuation, fire, hazard communication and Others, that complies with OSHA requirements.
CD/Recorded
$149
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Recorded/CD
Conformance of Design History Files for Mature Medical Devices

Conformance of Design History Files for Mature Medical Devices

  • Speaker: Rob Braido
  • Product ID: 702411
  • Duration: 60 Min
This webinar on Design History Files (DHF) will provide a step-by-step procedure for all medical device companies that are considering the need to bring their product design history files up to date with the current standards.
CD/Recorded
$229
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Recorded/CD
2-in-1 Virtual Seminar: FDA's Strategic Priorities and Supplier Control Requirements

2-in-1 Virtual Seminar: FDA's Strategic Priorities and Supplier Control Requirements

  • Speaker: John E Lincoln
  • Product ID: 703052
  • Duration: 3.5 hrs
This virtual seminar will start by evaluating important areas for regulated companies to focus in 2013-2014, based on the U.S. FDA’s recent "Strategic Priorities" initiative. The second-half of the session will discuss how FDA's global initiatives affect supplier chain management and vendor audits and how you can prepare to address them.
CD/Recorded
$499
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Recorded/CD
Dispelling the Myths About Clinical Standardization

Dispelling the Myths About Clinical Standardization

  • Speaker: Kit Howard
  • Product ID: 702494
  • Duration: 90 Min
This 90-minute webinar will examine the many myths that get in the way of clinical standards adoption and demonstrate how complying with required standards benefits both the FDA and sponsors.
CD/Recorded
$229
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Recorded/CD
Process Validation for Medical Devices - The Regulatory Approach

Process Validation for Medical Devices - The Regulatory Approach

  • Speaker: Dan OLeary
  • Product ID: 702673
  • Duration: 90 Min
This medical device process validation training will use recent warning letters to explain the regulatory requirements for process validation and what FDA Investigators look for. It will cover process validation components (IQ, OQ, and PQ), and the content of protocols and reports.
CD/Recorded
$229
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Recorded/CD
Essentials of Sterilizing Grade Filter Validation

Essentials of Sterilizing Grade Filter Validation

  • Speaker: Maik Jornitz
  • Product ID: 701654
  • Duration: 75 Min
This webinar on sterilizing grade filter validation will describe the essential requirements and steps for process validation of sterilizing grade filters. It will discuss multiple guidance documents in regard to sterilizing grade filtration and their interpretation.
CD/Recorded
$229
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