ComplianceOnline

Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

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
Effective Training Practices for FDA Compliance
24
/ Jan
Thursday-2019

Effective Training Practices for FDA Compliance

  • Speaker: Dr. Ludwig Huber
  • Product ID: 701243
  • Duration: 75 Min
This FDA compliance webinar will help the attendees develop an effective training program and training plans for an organization. Attendees will learn GxP training requirements in US and EU.
* 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
Root Cause Analysis - The Heart of Corrective Action
30
/ Jan
Wednesday-2019

Root Cause Analysis - The Heart of Corrective Action

  • Speaker: Betty Lane
  • Product ID: 703391
  • Duration: 60 Min
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
* 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
$229
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
$229
Understanding and Implementing a Quality by Design (QbD) Program
13
/ Feb
Wednesday-2019

Understanding and Implementing a Quality by Design (QbD) Program

  • Speaker: Steven Laurenz
  • Product ID: 705001
  • Duration: 60 Min
This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.
* Per Attendee
$199
Hazard Analysis and Product Risk Management Under ISO 14971 and ICH Q9
13
/ Feb
Wednesday-2019

Hazard Analysis and Product Risk Management Under ISO 14971 and ICH Q9

  • Speaker: John E Lincoln
  • Product ID: 701693
  • Duration: 60 Min
In this product risk management webinar attendees will understand the key requirements of ISO 14971 (2007 and 2012) and ICH Q9. Also attendees will learn how to develop and implement product risk management planning through ISO 14971 & ICH Q9 to increase the product safety and reduced liability.
* Per Attendee
$199
Process Capability for Normal and Non-Normal
13
/ Feb
Wednesday-2019

Process Capability for Normal and Non-Normal

  • Speaker: Steven Wachs
  • Product ID: 705020
  • Duration: 90 Min
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.
* Per Attendee
$229
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
14
/ Feb
Thursday-2019

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

  • Speaker: Dr. Ludwig Huber
  • Product ID: 701242
  • Duration: 75 Min
This excel validation training / webinar will demonstrate how to design spreadsheets for Part 11/GxP /SOX/HIPAA compliance. And how to document planning, specifications, installation, testing and changes to meet FDA requirements.
* Per Attendee
$199
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
14
/ Feb
Thursday-2019

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705583
  • Duration: 60 Min
In this webinar you will gain a basic to moderate knowledge of definition, purpose, importance of GDP, General rules of GDP, GDP as applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029> introduction “Good Documentation Guidelines”, A very brief introduction to European Union (EU) GDP, and finally its enforcement along with some observation samples from FDA.
* Per Attendee
$199
Surviving an FDA Sponsor Inspection - Training for Success
19
/ Feb
Tuesday-2019

Surviving an FDA Sponsor Inspection - Training for Success

  • Speaker: Stephen Schwartz
  • Product ID: 704516
  • Duration: 105 Min
This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.
* Per Attendee
$199
Sample Quality Control for Molecular Diagnostics
20
/ Feb
Wednesday-2019

Sample Quality Control for Molecular Diagnostics

  • Speaker: Todd Graham
  • Product ID: 705222
  • Duration: 60 Min
In this webinar attendees will learn the key issues and sample requirements (collection methods, sample inhibition and sample volume) for molecular diagnostics and the tools (PCR, DNA fluorescent assays & NGS assays) you need to deal with your laboratories challenges in clinical laboratory.
* Per Attendee
$199
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
20
/ Feb
Wednesday-2019

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

  • Speaker: Charity Ogunsanya
  • Product ID: 703885
  • Duration: 90 Min
This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.
* Per Attendee
$199
Current Concepts and Challenges in Cloud Compliance
21
/ Feb
Thursday-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.
* Per Attendee
$199
Recorded/CD
Technical Writing for Medical Products: SOPs, Investigations and Change Records

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.
CD/Recorded
$279
Recorded/CD
Cell Based Assays: Development and Validation

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.
Recorded/CD
Human Factors Engineering in New Product Development

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.
CD/Recorded
$249
Recorded/CD
Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

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.
CD/Recorded
$249
Recorded/CD
Verification vs. Validation in FDA Regulated Industries

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.
CD/Recorded
$249
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