WEBINARS

 

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

Implementation and Management of GMP Data Integrity

webinar-speaker   Danielle DeLucy

webinar-time   90 Min

Product Id: 705029

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

Recording Available

* Per Attendee $299

 

Software Validation and its 11 Key Documents

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 703097

This webinar focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.

Recording Available

* Per Attendee $299

 

Current Concepts and Challenges in Cloud Compliance

webinar-speaker   Angela Bazigos

webinar-time   90 Min

Product Id: 703739

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.

Recording Available

* Per Attendee $299

 

Data Governance for Computer Systems Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 704745

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.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 704848

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.

Recording Available

* Per Attendee $249

 

Computer System Validation and Part 11 Compliance

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705427

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.

Recording Available

 

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

webinar-speaker   Angela Bazigos

webinar-time   90 Min

Product Id: 703738

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.

Recording Available

* Per Attendee $249

 

How to Write Error Free and FDA Compliant Procedures

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704122

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.

Recording Available

* Per Attendee $249

 

Effective CDISC Clinical Data Acceptance Testing and Compliance

webinar-speaker   Sunil Gupta

webinar-time   75 Min

Product Id: 704687

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.

Recording Available

 

CDISC Cloud Computing in the Pharmaceutical Industry: Paradigm Shift in Project Management, Analysis and Validation

webinar-speaker   Sunil Gupta

webinar-time   75 Min

Product Id: 704674

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.

Recording Available

 

FDA Compliance and Laboratory Computer System Validation

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 704660

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.

Recording Available

 

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

webinar-speaker   Sunil Gupta

webinar-time   75 Min

Product Id: 704594

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.

Recording Available

 

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

webinar-speaker   Sunil Gupta

webinar-time   70 Min

Product Id: 704539

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.

Recording Available

 

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

webinar-speaker   Gaurav Walia

webinar-time   75 Min

Product Id: 704370

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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Philip Russ

webinar-time   90 Min

Product Id: 703355

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.

Recording Available

* Per Attendee $229

 

Using Electronic and Digital Signatures in Regulated Environments

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 702672

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.

Recording Available

* Per Attendee $229

 

FDA's cGMPs for the 21st Century Initiative

webinar-speaker   Betty Jones

webinar-time   60 Min

Product Id: 700620

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.

Recording Available

* Per Attendee $249

 

How to Buy COTS Software, and Audit and Validate Vendors

webinar-speaker   David Nettleton

webinar-time  

Product Id: 703820

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.

Recording Available

 

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

webinar-speaker   David Nettleton

webinar-time  

Product Id: 704734

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.

Recording Available

 

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

webinar-speaker   David Nettleton

webinar-time  

Product Id: 704533

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).

Recording Available

 

 

 

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