WEBINARS

 

Clinical Regulatory Compliance Training - Live Webinars, Recordings & CDs

Software Validation and its 11 Key Documents

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 703097

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.

Recording Available

* Per Attendee $299

 

CDISC Mapping 2: ODM, MindMaps and References

webinar-speaker   Sunil Gupta

webinar-time   90 Min

Product Id: 704208

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.

Recording Available

* Per Attendee $299

 

Risk Based Monitoring for GCP Compliance

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 705052

This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.

Recording Available

* Per Attendee $299

 

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

webinar-speaker   Regina Fullin

webinar-time   60 Min

Product Id: 704304

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.

Recording Available

* Per Attendee $229

 

The Most Serious FDA 483s - How to Avoid Them

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 702766

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.

Recording Available

* Per Attendee $299

 

FDA Regulations for Environmental Monitoring (EM) Program

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 704377

This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.

Recording Available

* Per Attendee $299

 

Current Concepts and Challenges in Cloud Compliance

webinar-speaker   Angela Bazigos

webinar-time   90 Min

Product Id: 703739

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.

Recording Available

* Per Attendee $299

 

CDISC Mapping 1: Specifications and FDA Requirements

webinar-speaker   Sunil Gupta

webinar-time   90 Min

Product Id: 704152

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).

Recording Available

* Per Attendee $299

 

FDA Compliance and Clinical Trial Computer System Validation

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 705358

This webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system.

Recording Available

* Per Attendee $199

 

Data Governance for Computer Systems Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 704745

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.

Recording Available

* Per Attendee $199

 

Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

webinar-speaker   Gwen Wise Blackman

webinar-time   180 Min

Product Id: 705019

This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.

Recording Available

* Per Attendee $349

 

Extractables and Leachables in Early Phase Development

webinar-speaker   Wayland Rushing

webinar-time   60 Min

Product Id: 704517

This training program will offer insight into where extractables and leachables come from. Attendees will learn the regulatory expectations and trends for extractables and leachables in early phase development and learn which products may require E&L data in early phases. The program will also focus on how to design programs to meet the needs of early phase development – i.e. phase appropriate E&L programs.

Recording Available

* Per Attendee $179

 

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

webinar-speaker   Charlie Sodano

webinar-time   75 Min

Product Id: 703576

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.

Recording Available

* Per Attendee $249

 

Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?

webinar-speaker   Peggy Berry

webinar-time   60 Min

Product Id: 705349

This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.

Recording Available

* Per Attendee $10

 

How to undergo an FDA Inspection Successfully

webinar-speaker   Marie Morin

webinar-time   90 Min

Product Id: 705170

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.

Recording Available

* Per Attendee $249

 

Building a Vendor Qualification Program for FDA Regulated Industries

webinar-speaker   Jonathan M Lewis

webinar-time   60 Min

Product Id: 703467

This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.

Recording Available

* Per Attendee $249

 

Bioavailability and Bioequivalence Studies submitted in NDAs and INDs

webinar-speaker   Stephanie Cooke

webinar-time   90 Min

Product Id: 705506

Attendees that need to perform bioavailability (BA) and bioequivalence (BE) studies for INDs, NDAs or for NDA supplements should attend this training. They will learn the requirements of such studies, per 21 CFR 320 and all other relevant regulatory documents.

Recording Available

* Per Attendee $279

 

How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)

webinar-speaker   Angela Bazigos

webinar-time   90 Min

Product Id: 705488

Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?

Recording Available

 

Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance

webinar-speaker   Sarah Fowler Dixon

webinar-time   60 Min

Product Id: 705451

This webinar will provide an understanding of the data integrity and data lifecycle within the GxP environment. Attendees will learn best practices to comply with the current regulations and industry standards for electronic data integrity throughout the data lifecycle.

Recording Available

 

Issues related to informed consent in clinical trials

webinar-speaker   Sarah Fowler Dixon

webinar-time   60 Min

Product Id: 705453

This webinar will discuss some common literacy trends, issues with consent documents and tips to enhance the consent process.

Recording Available

 

 

 

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