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    • Live Courses/Webinars
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HomeManufacturing (GMP)Effective Writing for Investigation Authors and Reviewers

Effective Writing for Investigation Authors and Reviewers

Teachers
Monica Guzman
Category:
Manufacturing (GMP)/ Medical Device Training/ On-Demand Courses/ Quality/ Regulatory & Compliance/
Clear
Duration: 90-Minutes
On-Demand
Includes Bonus Handouts!
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

Most authors and reviewers of investigation reports find the process of drafting and reviewing reports to be arduous and time consuming. With many investigation reports being unsuitable for an audit, the concern for how to write reports that are clear and concise takes center stage. 

This Effective Writing for Investigation Authors and Reviewers webinar helps you write deviation reports that demonstrate a thorough investigation has been conducted. It also helps reviewers understand the principles of good writing to provide consistent feedback to authors and make recommendations that are useful in an audit environment. 

This training provides a back-to-basics approach to technical writing skills targeted to improve the quality and readability of reports while ensuring compliance and positive audit results.

Content emphasizes identifying readers’ needs, writing clear, concise sentences, and organizing ideas to highlight logic throughout different sections of deviation reports.

LEARNING OBJECTIVES

At the completion of this session, you will be able to:

Meet Readers’ Needs

• Identify different reader types and their needs.
• Anticipate and answer auditors’ questions.
• Document the root cause credibly.

Assemble Content

• Enter content in appropriate sections of the report (group activity).
• Place leads strategically.
• Present investigation steps and corrective actions clearly and concisely.
• Use formatting to increase readability.

Polish for Readable Style

• Avoid word overload and control sentence length (group activities).
• Use transitions, active voice verbs, and parallel structure.
• Provide a high-level summary.
• Proofread to ensure accuracy, correct grammar, punctuation, and spelling.

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone working in a GMP regulated environment on global or domestic scale that authors, reviews, or revises investigation reports. This includes personnel in:

  • Quality
  • Manufacturing
  • Engineering
  • Other functions that may be subject to regulatory audits

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Monica Guzman
Monica Guzman is an Executive Coach and Corporate Trainer with over 12 years in the learning and development field.

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Clear
Duration: 90-Minutes
On-Demand
Includes Bonus Handouts!

CATEGORIES

  • Coronavirus / COVID-19 (4)
  • Clinical Trials (GCP Training) (110)
  • Introductory Pharma Courses (18)
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  • Live Webinars (7)
  • Manufacturing (GMP) (92)
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  • Research & Development (80)
  • Special Packages (5)

Upcoming Live Courses

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The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

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  • 215-675-1800 (option 3)
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