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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
How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

  • Speaker: Michael Levin
  • Product ID: 704274
  • Duration: 60 Min
Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.
CD/Recorded
$229
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Recorded/CD
Making Sense of BSCs, Hoods, Isolators, RABs

Making Sense of BSCs, Hoods, Isolators, RABs

  • Speaker: Joseph Winslow
  • Product ID: 704361
  • Duration: 60 Min
Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.
CD/Recorded
$229
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Recorded/CD
Veterinary Drug Approval Process and FDA's Regulatory Oversight

Veterinary Drug Approval Process and FDA's Regulatory Oversight

  • Speaker: Karl M. Nobert
  • Product ID: 703971
  • Duration: 60 Min
This training program will provide attendees with an introduction to FDA’s veterinary drug approval process. It will also discuss key components of an appropriate animal field study needed to support new animal drug approval and explain how jurisdiction is split between various federal agencies in certain cases.
CD/Recorded
$0
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Recorded/CD
Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

  • Speaker: Steven Wachs
  • Product ID: 705020
  • Duration: 75 Mins
This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.
CD/Recorded
$0
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Recorded/CD
Product Risk Management under FDA and ISO 14971:2007

Product Risk Management under FDA and ISO 14971:2007

  • Speaker: John E Lincoln
  • Product ID: 701176
  • Duration: 60 Min
This Product risk management training/webinar for Medical devices will help in to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007. The US FDA is increasingly stating that many regulated activities should be “risk-based”. Major resource-consuming activities such as product and process / equipment / facility, and software validation, CAPA investigations, vendor audits can all be tailored to a risk based approach. This eliminates the current SOP-defined “one size fits all” approach, to a flexible, resource adjusted approach, less arbitrarily defined in an SOP, but yielding results targeted to real needs. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry. Then how to use this document to accomplish the above goals.
CD/Recorded
$0
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Recorded/CD
Maintaining a Sustainable and Compliant Design Validation System and Using FMEA for Device Manufacturers

Maintaining a Sustainable and Compliant Design Validation System and Using FMEA for Device Manufacturers

  • Speaker: David Dills
  • Product ID: 701074
  • Duration: 60 Min
This webinar will provide valuable assistance and guidance for medical device companies to ensure they have a well defined, deployed and enforceable design validation program. Did I make the right product and can I prove it is Design Validation! Device manufacturers need to establish and maintain procedures for validating the device design. Design validation has to be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation must ensure that the company’s device or devices conform to defined user needs and intended uses and will include testing of production units under actual or simulated use conditions.
CD/Recorded
$299
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Recorded/CD
Risk Management as applied to Design Control

Risk Management as applied to Design Control

  • Speaker: Nicolaas Besseling
  • Product ID: 701212
  • Duration: 60 Min
This Risk management training will guide you through how to integrate the elements of ISO14971 (Risk management for medical devices) in your design process.
CD/Recorded
$299
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Recorded/CD
Bringing Compliance to Design Control through Life Cycle Management of Older Medical Devices and Surgical Instruments

Bringing Compliance to Design Control through Life Cycle Management of Older Medical Devices and Surgical Instruments

  • Speaker: Rob Braido
  • Product ID: 701230
  • Duration: 60 Min
This Life cycle management training will provide valuable assistance and gives a process to product design history files and technical files up to date with the new standards through life cycle management.
CD/Recorded
$299
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Recorded/CD
Human Factors Standards and Guidance's for Medical Devices - which documents apply to my situation?

Human Factors Standards and Guidance's for Medical Devices - which documents apply to my situation?

  • Speaker: Robert A North
  • Product ID: 700861
  • Duration: 60 Min
This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device.
CD/Recorded
$299
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Recorded/CD
Key differences in Design Control Requirements between ISO13485:2003 and the FDA Quality System Regulation

Key differences in Design Control Requirements between ISO13485:2003 and the FDA Quality System Regulation

  • Speaker: Dennis Moore
  • Product ID: 700192
  • Duration: 60 Min
Detailed analyses of the sections of the QSR design control regulations that have requirements not present in the ISO 13485:2003 standard. Many companies are confidant that their ISO 13485:2003 design control system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 design control cites are written and warning Letters, seizures or worse ensue.
CD/Recorded
$249
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Recorded/CD
Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Risk Management

Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Risk Management

  • Speaker: Vinny Sastri
  • Product ID: 700537
  • Duration: 60 Min
This Failure Modes and Effects Analysis (FMEA) Webinar will give an overview and elements of an FMEA. The analysis of data outputs will also be discussed.
CD/Recorded
$249
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Recorded/CD
Design Controls Basics - From Design Inputs to Design Outputs and Effective Design Transfer

Design Controls Basics - From Design Inputs to Design Outputs and Effective Design Transfer

  • Speaker: Vinny Sastri
  • Product ID: 700536
  • Duration: 60 Min
This Design Controls Webinar will provide a overview of all the steps involved in design controls and explain and clarify and state specific requirements in the regulations.
CD/Recorded
$249
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Recorded/CD
Viral Validation for Biopharmaceuticals

Viral Validation for Biopharmaceuticals

  • Speaker: Kathryn Martin Remington
  • Product ID: 700187
  • Duration: 60 Min
This Viral Validation webinar provide information on potential viral contaminants and their risks, expectations of regulatory agencies, effective methods of viral inactivation/removal, and important considerations in the design of a viral validation.
CD/Recorded
$249
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Recorded/CD
Risk Management Activities during Design Input

Risk Management Activities during Design Input

  • Speaker: Edwin L Bills
  • Product ID: 700526
  • Duration: 60 Min
Learn how to use tools such as Preliminary Hazard Analysis to eliminate expensive design changes that occur when problems are discovered during Design Verification and Design Validation. Risk Management Activities can lead to reduced cost and reduced time to market when conducted during the Design Input phase of product development. Learn how to use tools such as Preliminary Hazard Analysis to eliminate expensive design changes that occur when problems are discovered during Design Verification and Design Validation.
CD/Recorded
$149
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Recorded/CD
Common Problems and Mistakes in Method Validation in drug development process

Common Problems and Mistakes in Method Validation in drug development process

  • Speaker: Dr. Wise Blackman
  • Product ID: 700267
  • Duration: 60 Min
This Method Validation training in drug development process will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation. This web seminar will address frequently observed issues and problems with method validations.
CD/Recorded
$0
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Recorded/CD
How to set up a small-volume radiopharmaceuticals manufacturing facility

How to set up a small-volume radiopharmaceuticals manufacturing facility

  • Speaker: Shankar Seetharaman
  • Product ID: 700475
  • Duration: 60 Min
This Radiopharmaceuticals training will set out guidance and advice for those interested in setting up or improving an existing facility. Radiopharmaceutical manufacture is starting to begin a new phase as FDG now has a product licence
CD/Recorded
$249
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Recorded/CD
Bringing FDA Pharmaceutical GMPs into the 21st Century

Bringing FDA Pharmaceutical GMPs into the 21st Century

  • Speaker: Tony Dunbar
  • Product ID: 700346
  • Duration: 60 Min
This Pharmaceutical training will review the key aspects of Pharmaceutical GMPs for the 21st Century and Quality Systems Approach to Pharmaceutical CGMP Regulations.
CD/Recorded
$129
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Recorded/CD
Outsourcing analytical and pharmaceutical development

Outsourcing analytical and pharmaceutical development

  • Speaker: Michael Gamlen
  • Product ID: 700231
  • Duration: 60 Min
This webinar is targeted at people responsible for outsourcing, and at contractors who wish to ensure they provide excellent services which will generate them repeat business.
CD/Recorded
$0
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Recorded/CD
CGMPs for Investigational Drugs and Biologics

CGMPs for Investigational Drugs and Biologics

  • Speaker: Barbara Immel
  • Product ID: 700234
  • Duration: 60 Min
The European Union has stated their requirements in Annex 13, while FDA has recently issued a controversial new phase 1 guidance Join us for a discussion of actual requirements, and both historic and current guidance document recommendations
CD/Recorded
$299
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Recorded/CD
Design Input: How to write requirements and modularize a product

Design Input: How to write requirements and modularize a product

  • Speaker: Richelle Helman
  • Product ID: 700223
  • Duration: 60 Min
In this design Input training we will define design input, review robust requirements development, assess the impact of user needs vs. patient needs and discuss options for timing your design reviews.
CD/Recorded
$99
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