Regulatory Oversight

Regulatory Oversight

In partnership with IQC (Irish Quality Centre), the Regulatory Oversight module teaches you how to write technical documents for regulatory reviews.

Course delivery: 19 June 2020

Price: €250

Location: Online

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Course Outline

The Regulatory Oversight course teaches you the techniques for clear and concise audience focused writing, with particular focus on writing documents for regulatory compliance. This course will benefit all regulated industries including medtech, financial services, healthcare, life sciences, technology and governmental departments.

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Information Gathering

Develop audience-centric content.

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Editing/Reviewing

Develop editing and reviewing cycles.

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Structure

Structure content effectively.

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Style Guides

Apply style guides to support consistency

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Grammar

Fix grammar/punctuation errors.

Regulatory Oversight

Develop content to support regulatory compliance

Our Expertise

Our courses are designed to give you practical hands-on experience in the most relevant areas of content development. We provide:

Expert Trainers

Our experienced trainers deliver the course in an open and engaging manner, encouraging discussion on your specific issues, and reinforcing the learning through collaborative exercises. You will not be bored!

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Industry Knowledge

Every day our team supports leading companies to solve their technical communication challenges. This ensures our course delivers the current best practices to support you to meet the challenges of your particular industry.

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Customisation

We engage with you to understand your needs and then tailor our training material to ensure any course we deliver contains the most appropriate content for you.

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Added Value

Beyond training, some of our other services include: technical or business writing, editing and proofreading, information design, or project management and consulting.

Book Your Place Today

Improve your writing, editing, and documentation skills.

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Testimonials

This is what people have been saying about TWi's training courses.

"The trainers were great. Very knowledgeable, friendly and no question was too much for them. Great course, would recommend.”

-Janssen Pharmaceuticals

 

From start to finish TWi delivered a highly professional service. The approach of the tailored coaching session met my learning needs and I’m looking forward to putting my writing skills into practice and creating clear, concise, and effective content.”

-Vivienne Kelly, COO of Compass Informatics

"I attended the TWI Effective Writing Skills course in June this year and found it very helpful. The course was a combination of presentation, example and exercises that kept me engaged throughout the day. "

-Anne Gannon, Novate Medical

 

This is what people have been saying about IQC's training courses.

"The high point for me was gaining the understanding that it is not just about compliance but also effectiveness and improvement activities forming a critical part of the QMS."

-Boston Scientific

 

"The tutor was excellent. I really enjoyed how interactive the course was. Between exercises, questions, workshops and presentations it was quite comprehensive."

-Cambus Medical

 

Benefits

Our Technical Writing: Regulatory Oversight course includes practical exercises, key takeaways, and additional resources that maximise learning outcomes, helping you to:

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Write more confidently.

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Create technical content that is easy to understand.

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Develop regulatory compliant documentation to support your audits

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Enhance content quality, consistency, and usability.

Trainers

Oonagh Montague is a communications expert with more than twenty years' experience as a journalist,  lecturer, and senior project manager. She teaches Effective Writing Skills, Storytelling for Business, Understanding Audiences, Writing and Presentation Skills, and Media Marketing to audiences ranging from IT, medtech, and pharmaceutical professionals to third level students and academics. She is an engaging and intuitive trainer, who specialises in the translation of technical material into clear language, and the presentation of new or complex ideas to a specified audience.

 

 

 

 

Philip Byrne has over 25 years experience in auditing and management of Quality, Environmental, Health and Safety Management Systems. He has worked in Pfizer Ireland Pharmaceuticals for nine years supporting the drug substance manufacturing facility, playing a key role in Training, Quality, Technical and overall GMP compliance. Philip also lectures at the Technological University Dublin and Griffith College (Regulatory Affairs and GMP, Technology Transfer, Validation and GMP Auditing).

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Regulatory Oversight

Date: 19 June 2020

Location: Online

Price: €250