WEBINARS

 

Clinical Research Regulations and Guidance Training - Live Webinars, Recordings & CDs

FDA Pre-Approval Inspection Readiness: Actionable Steps to Prepare for a BIMO Inspection

webinar-speaker   Nicole Tesar

webinar-time   60 Min

Product Id: 704640

This 60-minute training program is designed for those working in the field of clinical research either as a sponsor (pharmaceutical/biotech company) or a research site. The session will discuss key FDA inspection terminology, types of BIMO inspections, site inspection procedures, and sponsor inspection procedures. Attendees will understand when an inspection is likely to be scheduled and the current trends in findings.

Recording Available

 

Effective CDISC Clinical Data Acceptance Testing and Compliance

webinar-speaker   Sunil Gupta

webinar-time   75 Min

Product Id: 704687

This CDISC training program will enumerate clinical data issues, effective methods and SAS macros to identify data issues, and communicating and monitoring improvements in clinical data issues.

Recording Available

 

Achieving Research Compliance Through Risk Assessment

webinar-speaker   Sarah Fowler Dixon

webinar-time   60 Min

Product Id: 704689

This training program will analyze the importance of research risks defined in 21 CFR 50 and 45 CFR 46. It will delve into how research risks affect IRB approval and review based on allowable actions in 21 CFR 50. The program will also discuss the need for indemnification language in consent forms based on risk levels.

Recording Available

 

Recruitment and Informed Consent: The Cornerstone of Ethical Clinical Research

webinar-speaker   Jennifer Holcomb

webinar-time   60 Min

Product Id: 704289

At the end of this training program, participants will be able to differentiate between consent and assent, identify when to use the long form and when to use the short form, describe the consent process using best practices.

Recording Available

* Per Attendee $229

 

FDA IDE: Investigational Device Exemption - What You Need To Know

webinar-speaker   Kesley Tyson

webinar-time   60 Min

Product Id: 704639

This program will identify regulations and guidelines pertaining to investigational device exemptions. Participants will learn to translate regulations and guidelines into practical application. The program will also discuss the dos/don’ts for conducting device trial activities through real-life examples.

Recording Available

 

CDISC Cloud Computing in the Pharmaceutical Industry: Paradigm Shift in Project Management, Analysis and Validation

webinar-speaker   Sunil Gupta

webinar-time   75 Min

Product Id: 704674

This training program will help you better manage projects and offer practical tools to understand data content and quality. Attendees will learn to apply validation methods to reduce time to validate clinical summary tables. Attendees will also learn to apply advanced SAS programming techniques to standardize and automate the validation process.

Recording Available

 

Pharmaceutical Company Specific Records and Information Management Programs

webinar-speaker   Charlie Sodano

webinar-time   60 Min

Product Id: 704667

This training program will focus on creating a workable and effective records and information policy. It will also discuss establishing records and information management responsibilities, determining the locations of all information resources, planning long term archiving, and content and records management software considerations and options.

Recording Available

 

ICH Addendum and its Implication on Clinical Development

webinar-speaker   Beat Widler

webinar-time   60 Min

Product Id: 704636

This training program will discuss investigator oversight and responsibilities, records management including source data, trial data handling and procedures, quality and risk management, vendor oversight and subcontracting, risk-based monitoring and last but not least root cause analyses in case of non-compliances.

Recording Available

 

Quality Writing for Technical Communicators

webinar-speaker   Phil Vassallo

webinar-time   60 Min

Product Id: 704017

This training program will address the daunting task of conveying complex technical data clearly, concisely, and purposefully to technical and non-expert audiences alike. Writing examples from diverse technical fields makes this webinar highly relevant. The program will build a foundation for learning by identifying the qualities of effective writing and the roadblocks to overcoming them.

Recording Available

* Per Attendee $199

 

FDA Vs Health Canada

webinar-speaker   Angela Dunston

webinar-time   60 Min

Product Id: 703970

This training program will elucidate the similarities and differences between the FDA and Health Canada promulgations of regulations impact preparation. The course will also offer a review of the background and history behind the FDA and Health Canada.

Recording Available

* Per Attendee $249

 

Best Practices in Being ‘On Call’ for FDA Submission Audits in the CDISC Programming Environment

webinar-speaker   Sunil Gupta

webinar-time   75 Min

Product Id: 704594

This training program will assist anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. It will help attendees in determining how well your company is positioned to defend your FDA submission.

Recording Available

 

Creating FDA-compliant cGMP Training Program

webinar-speaker   Henry Urbach

webinar-time   60 Min

Product Id: 703401

This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.

Recording Available

* Per Attendee $179

 

Adverse Event Reporting: Site and Sponsor Reporting Requirements for Investigational Products

webinar-speaker   Nicole Tesar

webinar-time   60 Min

Product Id: 704534

This training program will help attendees understand what adverse events, serious adverse events and unanticipated problems are, and why reporting them is important to a study hypothesis and is key to keeping subjects safe while on a clinical trial. They will also learn the responsibilities of the sponsor, site/clinical investigator and regulatory agency in reporting adverse events.

Recording Available

 

Applying SAS Program Validation Techniques Using Proc Tabulate to QC Summary Tables

webinar-speaker   Sunil Gupta

webinar-time   70 Min

Product Id: 704539

This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, 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 21CFR Part 11 or Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this course.

Recording Available

 

FDA Inspection Preparedness

webinar-speaker   Susan Muhr Leister

webinar-time   60 Min

Product Id: 704221

This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.

Recording Available

* Per Attendee $229

 

New Part 11 Guidance for Clinical Trials: What This Means for You

webinar-speaker   Sarah Fowler Dixon

webinar-time   60 Min

Product Id: 702990

This training on 21 CFR Part 11 guidance for clinical trials will explain the new 21 CFR Part 11 regulations for electronic records and what that means for your organization and the clincial studies you conduct.

Recording Available

* Per Attendee $229

 

FDA Inspection Lessons Learned: Lack of Trial Oversight

webinar-speaker   Janet Ellen Holwell

webinar-time   90 Min

Product Id: 704263

This training program will critically assess the number of major and critical 2012 inspection findings related to trial oversight. Attendees will learn to identify regulatory requirements for appropriate delegation of duties and investigator oversight.

Recording Available

* Per Attendee $50

 

Making Sense of BSCs, Hoods, Isolators, RABs

webinar-speaker   Joseph Winslow

webinar-time   60 Min

Product Id: 704361

Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.

Recording Available

* Per Attendee $229

 

FDA and MHRA Pharmacovigilance Inspection Readiness and Management

webinar-speaker   Kathleen Humel

webinar-time   60 Min

Product Id: 704181

This discussion is geared for the pharmaceutical industry. It will provide pharmacovigilance (product safety) departments with solid ideas to help them prepare for and manage a health authority inspection. Medical information, research and development and quality and compliance groups in the pharmaceutical industry would benefit from tips discussed in this session as well.

Recording Available

* Per Attendee $50

 

Making All Data Count: FDA Acceptance of non-US Clinical Trials

webinar-speaker   Mukesh Kumar

webinar-time   90 Min

Product Id: 702281

This webinar on FDA acceptance of non-US clinical trials will discuss the current FDA requirements for using clinical data from non-IND/IDE clinical trials in support of an IND and/or marketing approval application.

Recording Available

* Per Attendee $229

 

 

 

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