ComplianceOnline

FDA Documentation and IT 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.
Verification vs. Validation in Regulated Industries
10
/ Jan
Thursday-2019

Verification vs. Validation in 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
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
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
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
Project Management for Computer Systems Validation
26
/ Feb
Tuesday-2019

Project Management for Computer Systems Validation

  • Speaker: Angela Bazigos
  • Product ID: 702493
  • Duration: 90 Min
This computer system validation training will highlight the principles of project management that can be applied to 21 CFR Part 11 compliance for Computer Systems Validation and show how you can use project management tenets to deliver on time and on budget, while meeting FDA regulatory compliance 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
Validation and Use of Cloud Computing in FDA Regulated Environments

Validation and Use of Cloud Computing in FDA Regulated Environments

  • Speaker: Dr. Ludwig Huber
  • Product ID: 703423
  • Duration: 75 Min
This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.
CD/Recorded
$249
Recorded/CD
The FDA Inspection Process: From SOP to 483

The FDA Inspection Process: From SOP to 483

  • Speaker: Jeff Kasoff
  • Product ID: 700269
  • Duration: 60 Min
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
CD/Recorded
$375
Recorded/CD
Annual Current Good Manufacturing Practices (cGMP) Training

Annual Current Good Manufacturing Practices (cGMP) Training

  • Speaker: Shana Dressel
  • Product ID: 705422
  • Duration: 60 Min
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
CD/Recorded
$249
Recorded/CD
Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation

Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation

  • Speaker: Dr. Ludwig Huber
  • Product ID: 701547
  • Duration: 75 Min
This webinar focuses on 21 CFR Part 11 requirements stipulated by the FDA. It will also guide attendees on writing corrective and preventive action plans as follow up to 483s.
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
Japan: Regulatory Compliance Requirements for Life Science Products

Japan: Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 702979
  • Duration: 90 Min
This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
CD/Recorded
$249
Recorded/CD
How to Transition from Paper to Electronic Records in a Regulatory Environment

How to Transition from Paper to Electronic Records in a Regulatory Environment

  • Speaker: Charlie Sodano
  • Product ID: 703576
  • Duration: 75 Min
This webinar will cover effective and efficient ways to transition from paper to electronic records in a regulated environment. It will address compliance issues, complexity in decision making and implications specific to the pharmaceutical industry.
CD/Recorded
$249
Recorded/CD
Good Documentation Guideline (Chapter <1029> USP)

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
CD/Recorded
$249
Recorded/CD
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

  • Speaker: Joy McElroy
  • Product ID: 704531
  • Duration: 120 Min
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.
CD/Recorded
$249
Recorded/CD
How to undergo an FDA Inspection Successfully

How to undergo an FDA Inspection Successfully

  • Speaker: Marie Morin
  • Product ID: 705170
  • Duration: 90 Min
This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.
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
Understanding and Implementing USP <1058>: Analytical Instrument Qualification

Understanding and Implementing USP <1058>: Analytical Instrument Qualification

  • Speaker: Dr. Ludwig Huber
  • Product ID: 700067
  • Duration: 75 Min
This Analytical Instrument Qualification training will guide you through Understanding of draft for analytical instrument qualification - Essential steps and recommendations for firmware and software validation.
CD/Recorded
$249
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