ComplianceOnline
Current Concepts and Challenges in Cloud Compliance
7
/ Jan
Monday-2019

Current Concepts and Challenges in Cloud Compliance

  • Speaker: Angela Bazigos
  • Product ID: 703739
  • Duration: 90 Min
Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
Supplier Audits and Management
9
/ Jan
Wednesday-2019

Supplier Audits and Management

  • Speaker: Susanne Manz
  • Product ID: 705915
  • Duration: 90 Min
This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for managing your suppliers. You’ll learn about the essential elements of purchasing control and supplier audit. We’ll discuss the process steps for supplier control and how it relates to other parts of your QMS including receiving and acceptance activities. Also attendees will learn how to prevent quality and compliance problems by having a strong system for supplier audit and management! A well-designed supplier audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk.
* Per Attendee
$199
Verification vs. Validation in FDA Regulated Industries
10
/ Jan
Thursday-2019

Verification vs. Validation in FDA Regulated Industries

  • Speaker: John Chapman
  • Product ID: 700828
  • Duration: 60 Min
This webinar on verification vs. validation will help you to understand the differences between, and benefits of, verification and validation in both design and process operations in regulated industries. Learn about the risks and complications involved with the application of sound verification and validation principles.
* Per Attendee
$199
Human Factors Engineering in New Product Development
15
/ Jan
Tuesday-2019

Human Factors Engineering in New Product Development

  • Speaker: Tom Kramer
  • Product ID: 705153
  • Duration: 120 Min
This webinar will define human factors engineering and its role in the success of new product development. The session will use real world examples to demonstrate how human factors engineering makes a significant.
* Per Attendee
$199
Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration
15
/ Jan
Tuesday-2019

Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

  • Speaker: Jose Mora
  • Product ID: 703396
  • Duration: 90 Min
This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to controlled document system for a life sciences manufacturing plant.
* Per Attendee
$199
Cell Based Assays: Development and Validation
16
/ Jan
Wednesday-2019

Cell Based Assays: Development and Validation

  • Speaker: Michael Simonian
  • Product ID: 704528
  • Duration: 60 Min
This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.
* Per Attendee
$199
Technical Writing for Medical Products: SOPs, Investigations and Change Records
17
/ Jan
Thursday-2019

Technical Writing for Medical Products: SOPs, Investigations and Change Records

  • Speaker: Regina Fullin
  • Product ID: 704304
  • Duration: 120 Min
In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.
* Per Attendee
$229
Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971
17
/ Jan
Thursday-2019

Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971

  • Speaker: Tanvir Mahmud
  • Product ID: 702422
  • Duration: 90 Min
This 90-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.
* Per Attendee
$199
Data Governance for Computer Systems Regulated by FDA
23
/ Jan
Wednesday-2019

Data Governance for Computer Systems Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 704745
  • Duration: 60 Min
In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.
* Per Attendee
$199
ISO 13485:2016 - What are the hot topics and changes?
28
/ Jan
Monday-2019

ISO 13485:2016 - What are the hot topics and changes?

  • Speaker: Frank Stein
  • Product ID: 705864
  • Duration: 90 Min
In this quality management system webinar attendees will learn the recent changes to ISO 13485:2016 standard in step by step process and how to implement these changes in their current quality management system to pass the quality management audit. Also attendees will gain knowledge on how to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems.
* Per Attendee
$199
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
30
/ Jan
Wednesday-2019

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

  • Speaker: Robert J Russell
  • Product ID: 705370
  • Duration: 90 Min
This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.
* Per Attendee
$199
Confidence/Reliability & Tolerance Calculations for Extremely Non-Normal Data
31
/ Jan
Thursday-2019

Confidence/Reliability & Tolerance Calculations for Extremely Non-Normal Data

  • Speaker: John N Zorich
  • Product ID: 705908
  • Duration: 90 Min
Standard methods of statistical analysis of process capabilities require normally distributed data or transformations to normality. When that is impossible, due to data having a bimodal or other distribution, the only practical alternative to calculating a high level of confidence/reliability or an acceptable Tolerance limit is to use Reliability Plotting.
* Per Attendee
$199
Complaint Handling, MDR's & Recalls
7
/ Feb
Thursday-2019

Complaint Handling, MDR's & Recalls

  • Speaker: John Chapman
  • Product ID: 700830
  • Duration: 60 Min
This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.
* Per Attendee
$199
Confidence/Reliability Calculations of Product and Product Capability
12
/ Feb
Tuesday-2019

Confidence/Reliability Calculations of Product and Product Capability

  • Speaker: John N Zorich
  • Product ID: 705912
  • Duration: 90 Min
In this webinar attendees will learn the specific easy-to-use formulas for calculating what % a population or process is "in-specification" (= % Reliability). This webinar focuses on explaining which formulas to use for what type of data, and when/how to perform transformations to normality prior to using such formulas.
* Per Attendee
$199
Understanding FDA Design Verification and Validation Requirements for Medical Devices
12
/ Feb
Tuesday-2019

Understanding FDA Design Verification and Validation Requirements for Medical Devices

  • Speaker: Meena Chettiar
  • Product ID: 705331
  • Duration: 75 Min
This webinar will help you understand specific product verification and validation requirements for medical devices to comply with ISO 13485: 2016 and FDA quality system regulations. It will focus on the topics such as product development process, traceability and risk management at all stages, design outputs and documentation in DMR and DHR, design verification and design validation activity cycles and more.
* Per Attendee
$179
Recorded/CD
Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment

Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment

  • Speaker: Gerry O Dell
  • Product ID: 701929
  • Duration: 90 Min
This webinar will address the most current (regulatory) expectations for cleaning validation of reusable medical devices that are performed in support of the instructions in the instruction for use (IFU).
CD/Recorded
$249
Recorded/CD
How to write SOP's that Avoid Human Error

How to write SOP's that Avoid Human Error

  • Speaker: Ginette M Collazo
  • Product ID: 704418
  • Duration: 90 Min
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
CD/Recorded
$249
Recorded/CD
Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

  • Speaker: John E Lincoln
  • Product ID: 704848
  • Duration: 90 Min
A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.
CD/Recorded
$249
Recorded/CD
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

  • Speaker: Jose Mora
  • Product ID: 705692
  • Duration: 90 Min
CD/Recorded
$249
Recorded/CD
Cost of Quality - Application in Medical Devices Companies

Cost of Quality - Application in Medical Devices Companies

  • Speaker: Yuval Shapiro
  • Product ID: 705869
  • Duration: 60 Min
This quality management system webinar will discuss how to implement effectively a Cost of Quality System (Data collection, Analysis and Metrics) using the mechanism of 6Sigma DMAIC. Also this presentation will address costs of failure and costs of appraisal.
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