Webinars

Webinars

RoseTECH Consulting offers training in a webinar format. The “live” webinar format allows for interaction, and Q&A, between the trainer and the attendees.  As with the onsite training, signed dated training certificates are awarded to all attendees completing the training.

Below is a list of  onsite and webinar training topics that RoseTECH offers.
(Scroll down for descriptions)

  • GLP Amendments, Deviations and Unforeseen Circumstances:
    The Good, the Bad and the Ugly

  • The Brass Tacks of GLP:
    Practical Understanding of the Fundamentals As Never Before Explained

  • Overview of GLP Regulatory Requirements for Documentation

  •  Study Director  Roles & Responsibilities …it’s not just 21 CFR Part 58.33

  • Good Recordkeeping Practices

  • GLP Study Reconstructibility – Protocol Through Final Report

  • Effective Writing of Protocols, Amendments, Deviations, &Study Reports

  • GLP Standard Operating Procedures 

GLP Amendments, Deviations and Unforeseen Circumstances:
The Good, the Bad and the Ugly

All experimental data generated in a GLP study, including observations of unanticipated responses, are required to be accurately recorded and verified. Proper documentation of deviations and events is crucial to the reconstructability of a GLP study and the quality and compliance of the study report. Documentation of protocol and SOP deviations and unexpected events can be problematic if not handled properly, and can impact the integrity of the study.  This session defines amendments, deviations and unforeseen circumstances, the similarities and differences, and presents strategies for the prevention and/or minimization of the potential for the occurrence of unnecessary deviations, as well as proper documentation of the inevitable. Effective tactics to enhancing proper GLP-compliant documentation and handling of deviations are discussed and includes approaches to reducing the stigma of deviations so as to foster good communication between study personnel and study director when deviations and unusual events do occur.

The Brass Tacks of GLP – Practical Understanding of the Fundamentals As Never Before Explained

This session takes a different approach to learning and understanding the GLPs.  There are basically six fundamental principles of GLP – Control/Accountability; Clear Study Design/Objectives; Prevention of Contamination, Mix-up or Deterioration; Data Quality & Integrity; Accurate Results/Conclusions; and ultimately RECONSTRUCTIBILITY.  Acknowledgement of the premises of GLPs fundamental principles lays the foundation to allow us to incorporate GLPs instinctively into our everyday functions.

Overview of GLP Regulatory Requirements for Documentation

This session includes of brief history of why GLP regulations exist and covers the types of written documents and records required by GLPs as well as the good documentation requirements specified in the regulations.  Topics covered include: study protocols, protocol amendments, and pros and cons of putting study procedures in SOPs vs. protocols.

Study Director  Roles & Responsibilities …it’s not just 21 CFR Part 58.33

Overview of FDA/EPA/ and OECD Good Laboratory Practice Standards with a focus on the regulatory requirements and responsibilities of a GLP Study Director & Principal Investigator.   In addition to technical and regulatory qualifications, other skills important for effective study direction will be covered.

 Good Recordkeeping Practices

This session covers general good record-keeping practices, documentation of raw data, manual and electronic data recording rules, complying with 21 CFR 11 requirements, proper error corrections, and record-keeping Dos and Don’ts.

GLP Study Reconstructibility – Protocol Through Final Report

Reconstructibility is the ultimate reason for good documentation and impacts the validity, integrity and compliance of GLP studies.  Reconstructible documentation is imperative to the quality and compliance of a GLP study.  This session covers quality documentation including protocols, amendments, deviations, raw data and study documentation, and final reports. 

Effective Writing of Protocols, Amendments, Deviations, and Study Reports

Clear, concise writing is a key to study reconstructibility.  This session covers protocol, protocol amendment, and report writing and effective documentation of deviations and unexpected circumstances, with a focus on writing for the “reader” and includes technical writing “helpful hints” and report organization skills to produce well-written documents.  This session covers the required components of GLP protocols, amendments and reports.  It stresses the importance of writing detailed, yet flexible protocols, and how to avoid “protocol pitfalls” that lead to unnecessary deviations and amendments.  This session covers the required components of GLP study reports, and how to write reports with clear, concise, and accurate results and conclusions, including how to tactfully and truthfully deal with problematic results. “Real” examples of poor wording are shown for illustration.

GLP Standard Operating Procedures

This session covers the types of SOPs required by the GLP regulations, explicitly and implicitly.  It also will discuss SOP format and content and the importance of “Say What You Do and Do What You Say”.  SOP deviations are also covered.