ComplianceOnline
FDA's Ambitious Regulation of Social Media
24
/ Jun
Monday-2019

FDA's Ambitious Regulation of Social Media

  • Speaker: Casper Uldriks
  • Product ID: 703853
  • Duration: 60 Min
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
* Per Attendee
$229
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
Laboratory Investigations Relating to Sample Re-Analysis: Covering the Basics Before Being Called Out
28
/ Jun
Friday-2019

Laboratory Investigations Relating to Sample Re-Analysis: Covering the Basics Before Being Called Out

  • Speaker: Edward O Connor
  • Product ID: 701439
  • Duration: 60 Min
This webinar on laboratory investigation will provide guidance on procedures used in investigating unexpected results for non-clinical and clinical trials and will discuss several suggested procedures, avoiding unnecessary re-analysis.
* 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. 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.
* Per Attendee
$249
Use of Wearable Devices in Clinical Trials
11
/ Jul
Thursday-2019

Use of Wearable Devices in Clinical Trials

  • Speaker: Barry Peterson
  • Product ID: 706061
  • Duration: 60 Min
This webinar will provide a basic understanding of how devices work, how to identify quality devices, how to get the most value from the information collected, and how to be well positioned for the growth in this field. The new mobile devices guidelines provided by the Clinical Trials Transformation Initiative (CTTI, a private/public partnership initiated by Duke University and the FDA) will be reviewed.
* 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
Bioanalytical Methods Validation
12
/ Jul
Friday-2019

Bioanalytical Methods Validation

  • Speaker: Edward O Connor
  • Product ID: 701769
  • Duration: 60 Min
This training on bio-analytical methods validation will help you understand the clear, consistent and compliant approaches for instrumental, ligand binding, and cell based methods. A comparison of EMEA and FDA guidances will be presented.
* Per Attendee
$229
Requirements for Running Clinical Trials in Pediatrics for the EU
12
/ Jul
Friday-2019

Requirements for Running Clinical Trials in Pediatrics for the EU

  • Speaker: Laura Brown
  • Product ID: 701983
  • Duration: 60 Min
This training will cover compliance requirements for running clinical trials in pediatrics, particularly in the EU to comply with the EU ethical considerations guidance for running clinical trials in pediatrics.
* Per Attendee
$229
How to Establish and Maintain a Compliant, Practical Clinical Quality Management System in a Changing Organization
18
/ Jul
Thursday-2019

How to Establish and Maintain a Compliant, Practical Clinical Quality Management System in a Changing Organization

  • Speaker: Penelope Przekop
  • Product ID: 706062
  • Duration: 90 Min
Global regulators require your company to have a robust QMS, regardless of company size, situation, or outsourcing strategy. In this webinar, learn how to establish and maintain a compliant and practical Clinical Quality System during process improvement efforts and/or company growth that can be clearly understood, communicated, and embraced from the top to bottom of your organization.
* Per Attendee
$249
The Impact of ICH E6 R2
13
/ Aug
Tuesday-2019

The Impact of ICH E6 R2

  • Speaker: Pam Dellea Giltner
  • Product ID: 706064
  • Duration: 60 Min
This webinar will discuss the overall impact of the updated GCP ICH E6 (R2) Addendum and what this means for you, your company and selected vendors.
* Per Attendee
$229
Surviving an FDA Sponsor Inspection - Training for Success
20
/ Aug
Tuesday-2019

Surviving an FDA Sponsor Inspection - Training for Success

  • Speaker: Stephen Schwartz
  • Product ID: 704516
  • Duration: 105 Min
This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.
* Per Attendee
$249
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
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
Developing Practical and Successful GCP and GVP Audit & Inspection CAPAs

Developing Practical and Successful GCP and GVP Audit & Inspection CAPAs

  • Speaker: Penelope Przekop
  • Product ID: 706072
  • Duration: 90 Min
This Webinar will focus on how to use SMART goals as a framework to draft submission-ready GCP and/or GVP CAPAs that not only adequately address observations but are also practical given your organization’s unique goals and challenges. Anecdotes and examples will be provided to lend context, and tools shared to give you the confidence to write successful CAPAs.
Recorded/CD
Good Clinical Practice R2 addendum only

Good Clinical Practice R2 addendum only

  • Speaker: Linda Hopkinson
  • Product ID: 706088
  • Duration: 90 Min
This webinar will provide you with a recap into what is Good Clinical Practice (GCP) and help you understand why the Revision 2 addendum was required. It will allow you to understand the implications of this revision for clinical research trials and gain the knowledge to fully comply with ICH GCP. It will provide an overview of what additions were added in the R2 addendum.
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
How to Manage Your Vendors in Clinical Research

How to Manage Your Vendors in Clinical Research

  • Speaker: Pam Dellea Giltner
  • Product ID: 705958
  • Duration: 90 Min
This vendor management webinar will show you how to choose the right vendor, onboarding and set up, manage vendor performance, manage issues and ensure compliance with current FDA regulations and ICH guidelines and have a smooth-running clinical study.
CD/Recorded
$299
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
Project Management for Auditors - Improving audit productivity for GCP, GMP and GLP

Project Management for Auditors - Improving audit productivity for GCP, GMP and GLP

  • Speaker: Laura Brown
  • Product ID: 701982
  • Duration: 60 Min
This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.
CD/Recorded
$299
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
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