ComplianceOnline

Documentation and Data Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
24
/ Apr
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
Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities
25
/ Apr
Thursday-2019

Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities

  • Speaker: Robert J Russell
  • Product ID: 701367
  • Duration: 90 Min
This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.
* Per Attendee
$249
CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)
29
/ May
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
How to Prepare a Standard Operating Procedure (SOP)?
31
/ May
Friday-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
U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics
4
/ Jun
Tuesday-2019

U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics

  • Speaker: Norma Skolnik
  • Product ID: 704371
  • Duration: 60 Min
In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues.
* Per Attendee
$199
FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More
13
/ Jun
Thursday-2019

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

  • Speaker: Danielle DeLucy
  • Product ID: 704659
  • Duration: 60 Min
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
* Per Attendee
$229
CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE
19
/ Jun
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
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
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
How to Conduct Annual Product Reviews to Achieve GMP Compliance

How to Conduct Annual Product Reviews to Achieve GMP Compliance

  • Speaker: Danielle DeLucy
  • Product ID: 704993
  • Duration: 60 Min
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.
CD/Recorded
$299
Recorded/CD
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer

  • Speaker: Gregory Martin
  • Product ID: 703644
  • Duration: 90 Min
This training on using the QbD approach to analytical method lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. The webinar presenter will use case studies to illustrate each stage in the process.
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
FDA Regulations for Marketing OTC Drugs and New Legislation

FDA Regulations for Marketing OTC Drugs and New Legislation

  • Speaker: Norma Skolnik
  • Product ID: 704145
  • Duration: 60 Min
This training program will illustrate why it’s essential to understand FDA regulations and OTC labeling requirements to market OTC drugs in the U.S.
CD/Recorded
$299
Recorded/CD
Technical Writing for Medical Products: SOPs, Investigations and Change Records

Technical Writing for Medical Products: SOPs, Investigations and Change Records

  • Speaker: Regina Fullin
  • Product ID: 704304
  • Duration: 60 Min
In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.
CD/Recorded
$299
Recorded/CD
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

  • Speaker: Roger Cowan
  • Product ID: 703476
  • Duration: 60 Min
This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.
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
CDISC Mapping 1: Specifications and FDA Requirements

CDISC Mapping 1: Specifications and FDA Requirements

  • Speaker: Sunil Gupta
  • Product ID: 704152
  • Duration: 90 Min
This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).
CD/Recorded
$299
Recorded/CD
Understanding and Implementing a Quality by Design (QbD) Program

Understanding and Implementing a Quality by Design (QbD) Program

  • Speaker: Steven Laurenz
  • Product ID: 705001
  • Duration: 60 Min
This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.
CD/Recorded
$299
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