ComplianceOnline

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

Japan: Regulatory Compliance Requirements for Life Science Products
23
/ Aug
Friday-2019

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.
* 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
Avoid Documentation 'Time Bombs'
11
/ Sep
Wednesday-2019

Avoid Documentation 'Time Bombs'

  • Speaker: John E Lincoln
  • Product ID: 701407
  • Duration: 60 Min
This documentation training will explain regulatory ramification of communication done through Lab books, SOPs, DHF, technical files etc and how to reduce it.
* Per Attendee
$229
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
19
/ Sep
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, 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
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
8
/ Oct
Tuesday-2019

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.
* Per Attendee
$299
Good Documentation Guideline (Chapter <1029> USP)
24
/ Oct
Thursday-2019

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.
* Per Attendee
$229
How to Prepare a Standard Operating Procedure (SOP)?
19
/ Nov
Tuesday-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
4-Hr Virtual Training: How to Respond to an FDA Investigation
4
/ Dec
Wednesday-2019

4-Hr Virtual Training: How to Respond to an FDA Investigation

  • Speaker: Joy McElroy
  • Product ID: 704549
  • Duration: 4 hrs
This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.
* Per Attendee
$399
Recorded/CD
CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

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.
CD/Recorded
$299
Recorded/CD
CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

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.
CD/Recorded
$299
Recorded/CD
Annual Current Good Manufacturing Practices (cGMP) Training

Annual Current Good Manufacturing Practices (cGMP) Training

  • Speaker: David L Chesney
  • 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
Implementation and Management of GMP Data Integrity

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. 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.
CD/Recorded
$299
Recorded/CD
CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

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.
CD/Recorded
$299
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
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
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