ComplianceOnline

FDA 21 CFR Part 11 Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.
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
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
Implementation and Management of GMP Data Integrity

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in CGMP for US FDA regulated industry. Data integrity and security infractions are not only 21 CFR Part 11 issues but also severe CGMP violations.
CD/Recorded
$249
Recorded/CD
Computer System Validation and Part 11 Compliance

Computer System Validation and Part 11 Compliance

  • Speaker: Joy McElroy
  • Product ID: 705427
  • Duration: 60 Min
This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.
Recorded/CD
Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts

Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts

  • Speaker: Angela Bazigos
  • Product ID: 703738
  • Duration: 90 Min
This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.
CD/Recorded
$249
Recorded/CD
How to Write Error Free and FDA Compliant Procedures

How to Write Error Free and FDA Compliant Procedures

  • Speaker: Ginette M Collazo
  • Product ID: 704122
  • Duration: 90 Min
This training program will focus on the importance of procedures. Attendees will learn why people avoid procedures and understand common human errors and deviations related to the use of procedures.
CD/Recorded
$249
Recorded/CD
Effective CDISC Clinical Data Acceptance Testing and Compliance

Effective CDISC Clinical Data Acceptance Testing and Compliance

  • Speaker: Sunil Gupta
  • Product ID: 704687
  • Duration: 75 Min
This CDISC training program will enumerate clinical data issues, effective methods and SAS macros to identify data issues, and communicating and monitoring improvements in clinical data issues.
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.
Recorded/CD
FDA Compliance and Laboratory Computer System Validation

FDA Compliance and Laboratory Computer System Validation

  • Speaker: Carolyn Troiano
  • Product ID: 704660
  • Duration: 60 Min
Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework. They will have received the guidance on industry best practices necessary to develop a compliant and cost-effective validation program. They will understand the steps for validating laboratory systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. Attendees will gain a good grasp of how to leverage these practices across all systems by creating a standardized program.
Recorded/CD
Best Practices in Being ‘On Call’ for FDA Submission Audits in the CDISC Programming Environment

Best Practices in Being ‘On Call’ for FDA Submission Audits in the CDISC Programming Environment

  • Speaker: Sunil Gupta
  • Product ID: 704594
  • Duration: 75 Min
This training program will assist anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. It will help attendees in determining how well your company is positioned to defend your FDA submission.
Recorded/CD
Applying SAS Program Validation Techniques Using Proc Tabulate to QC Summary Tables

Applying SAS Program Validation Techniques Using Proc Tabulate to QC Summary Tables

  • Speaker: Sunil Gupta
  • Product ID: 704539
  • Duration: 70 Min
This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be 21CFR Part 11 or Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this course.
Recorded/CD
Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance

Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance

  • Speaker: Gaurav Walia
  • Product ID: 704370
  • Duration: 75 Min
This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.
CD/Recorded
$229
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
Recorded/CD
The 11 Must-have Documents of Software Verification and Validation

The 11 Must-have Documents of Software Verification and Validation

  • Speaker: John E Lincoln
  • Product ID: 703097
  • Duration: 90 Min
This webinar focuses on the verification and validation planning and execution of software after basic developmental testing and de-bug. A suggested 11-element FDA model will be evaluated, implemented, with V&V documentation and test case examples.
CD/Recorded
$229
Recorded/CD
Using Electronic and Digital Signatures in Regulated Environments

Using Electronic and Digital Signatures in Regulated Environments

  • Speaker: Dr. Ludwig Huber
  • Product ID: 702672
  • Duration: 75 Min
This webinar will familiarize you with FDA requirements for electronic and digital signatures, and the agency's inspection and enforcement practices. Particpants will recieve complimentary hand-outs for easy implementation.
CD/Recorded
$229
Recorded/CD
FDA's cGMPs for the 21st Century Initiative

FDA's cGMPs for the 21st Century Initiative

  • Speaker: Betty Jones
  • Product ID: 700620
  • Duration: 60 Min
This FDA’s cGMPs training/webinar will provide and insider’s view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches.
CD/Recorded
$249
Recorded/CD
How to Buy COTS Software, and Audit and Validate Vendors

How to Buy COTS Software, and Audit and Validate Vendors

  • Speaker: David Nettleton
  • Product ID: 703820
  • Duration:
This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.
Recorded/CD
The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications

The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications

  • Speaker: David Nettleton
  • Product ID: 704734
  • Duration:
This training program will identify data and systems subject to Part 11 and Annex 11. It will also decode what the regulations mean and illustrate the current computer system industry standards for security, data transfer, and audit trails.
Recorded/CD
21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s

21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s

  • Speaker: David Nettleton
  • Product ID: 704533
  • Duration:
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
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