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Clinical Regulatory Compliance Training - Live Webinars, Recordings & CDs

/ Dec

Wednesday-2018

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

Speaker: Gwen Wise Blackman
Product ID: 705019
Duration: 180 Min

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.

* Per Attendee
$299

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/ Jan

Wednesday-2019

Data Governance for Computer Systems Regulated by FDA

Speaker: Carolyn Troiano
Product ID: 704745
Duration: 60 Min

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.

* Per Attendee
$199

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/ Jan

Wednesday-2019

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Speaker: Robert J Russell
Product ID: 705370
Duration: 90 Min

This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.

* Per Attendee
$199

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Recorded/CD

Extractables and Leachables in Early Phase Development

Speaker: Wayland Rushing
Product ID: 704517
Duration: 60 Min

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.

CD/Recorded
$279

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Recorded/CD

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.

CD/Recorded
$279

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Recorded/CD

Implementation and Management of GMP Data Integrity

Speaker: Danielle DeLucy
Product ID: 705029
Duration: 90 Min

Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in CGMP for US FDA regulated industry. Data integrity and security infractions are not only 21 CFR Part 11 issues but also severe CGMP violations.

CD/Recorded
$249

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Recorded/CD

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.

CD/Recorded
$249

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Recorded/CD

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

Speaker: Charlie Sodano
Product ID: 703576
Duration: 75 Min

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.

CD/Recorded
$249

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