ComplianceOnline

FDA Documentation and IT Regulatory Compliance Training - Live Webinars, Recordings & CDs

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
19
/ Jun
Wednesday-2019

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

  • Speaker: Sunil Gupta
  • Product ID: 704302
  • Duration: 90 Min
This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, 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 Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.
* Per Attendee
$249
Annual Current Good Manufacturing Practices (cGMP) Training
26
/ Jun
Wednesday-2019

Annual Current Good Manufacturing Practices (cGMP) Training

  • Speaker: Kelly Thomas
  • 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.
* Per Attendee
$199
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
28
/ Jun
Friday-2019

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

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705583
  • Duration: 60 Min
In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.
* Per Attendee
$229
Implementation and Management of GMP Data Integrity
3
/ Jul
Wednesday-2019

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. Also attendees will examples of data integrity pitfalls, • part 11 compliance data integrity issues, FDA citations related to data integrity and how to improve data integrity in a laboratory environment.
* Per Attendee
$249
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
10
/ Jul
Wednesday-2019

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

  • Speaker: David Nettleton
  • Product ID: 701582
  • Duration: 75 Min
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
* Per Attendee
$229
How to Prepare a Standard Operating Procedure (SOP)?
11
/ Jul
Thursday-2019

How to Prepare a Standard Operating Procedure (SOP)?

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705131
  • Duration: 60 Min
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
* Per Attendee
$229
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
7
/ Aug
Wednesday-2019

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

  • Speaker: David Nettleton
  • Product ID: 701687
  • Duration: 90 Min
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).
* Per Attendee
$229
CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)
21
/ Aug
Wednesday-2019

CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

  • Speaker: Sunil Gupta
  • Product ID: 704313
  • Duration: 90 Min
This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.
* Per Attendee
$249
Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
27
/ Aug
Tuesday-2019

Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

  • Speaker: Kenneth Christie
  • Product ID: 703635
  • Duration: 90 Min
This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.
* Per Attendee
$249
CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE
18
/ Sep
Wednesday-2019

CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

  • Speaker: Sunil Gupta
  • Product ID: 704316
  • Duration: 90 Min
This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide effective and practical solutions to address real-world issues.
* Per Attendee
$249
Recorded/CD
21 CFR 11 Compliance for Excel Spreadsheet

21 CFR 11 Compliance for Excel Spreadsheet

  • Speaker: Angela Bazigos
  • Product ID: 702450
  • Duration: 90 Min
This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Part 11 validation.
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
$299
Recorded/CD
New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

  • Speaker: Angela Bazigos
  • Product ID: 704529
  • Duration: 90 Min
This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.
CD/Recorded
$249
Recorded/CD
Software Validation and its 11 Key Documents

Software Validation and its 11 Key Documents

  • 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. 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.
CD/Recorded
$299
Recorded/CD
CDISC Mapping 2: ODM, MindMaps and References

CDISC Mapping 2: ODM, MindMaps and References

  • Speaker: Sunil Gupta
  • Product ID: 704208
  • Duration: 90 Min
This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.
CD/Recorded
$299
Recorded/CD
Writing Effective and compliant SOPs

Writing Effective and compliant SOPs

  • Speaker: Angela Bazigos
  • Product ID: 702429
  • Duration: 90 Min
This FDA compliant SOPs training will explain how to write, organize, and maintain Standard Operating Procedures (SOPs) and train personnel so that you can ensure FDA compliance in a way that is concise, reproducible and easy to follow.
CD/Recorded
$299
Recorded/CD
The Most Serious FDA 483s - How to Avoid Them

The Most Serious FDA 483s - How to Avoid Them

  • Speaker: John E Lincoln
  • Product ID: 702766
  • Duration: 90 Min
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.
CD/Recorded
$299
Recorded/CD
Current Concepts and Challenges in Cloud Compliance

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.
CD/Recorded
$299
Recorded/CD
Project Management for Computer Systems Validation

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.
CD/Recorded
$399
Recorded/CD
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

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.
CD/Recorded
$299
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