Documentation and Medical Writing Training for Pharmaceutical Regulatory Affairs Professionals

Regulatory documentation and medical writing are vital skills for regulatory affairs professionals. You need to write RA-specific SOPs and support due diligence reviews, protocol reviews, report reviews, and other regulatory documentation pertaining to quality, safety, and efficacy.

To develop a document that complies with regulatory requirements, you must combine writing abilities with subject matter knowledge and information from regulatory guidelines. Writing clearly, concisely, completely, and accurately can help you accelerate your career growth and organization’s business growth.

ComplianceOnline has engaged elite experts to provide detailed documentation and medical writing knowledge for you and your team through the following training bundle. This bundle is ideal for new and experienced regulatory affairs professionals who want to hone their documentation and medical writing skills.

See what’s covered in the training bundle

Introduction to FDA Good Documentation Practices
Avoid Documentation 'Time Bombs'
The common technical dossier - guidance on writing the overviews and summaries
Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?
CMC Considerations for INDs and NDAs for 505(b)(2) Products
How to write SOPs that Avoid Human Error

Introduction to FDA Good Documentation Practices

This FDA Good Documentation Practices training will introduce and explain the concept of Good Documentation Practices, and provide real-world examples of how to, and how not to, use GDPs.

Areas Covered in the Webinar:

• What are Good Documentation Practices?
• How and when to apply Good Documentation Practices
• How to complete documentation such as data collection forms and batch records
• How to attach raw data to forms and lab notebooks
• How to correct errors and ommissions in data entry
• How to sign, date and label data and records

Avoid Documentation 'Time Bombs'

This documentation training will explain regulatory ramification of communication done through Lab books, SOPs, DHF, technical files etc. and how to reduce it.

Areas Covered in the Webinar:

• The problems.
• Electronic "eternity".
• Hard copy headaches.
• Regulatory issues.
• Potential legal issues for non-lawyers.
• Solving the problem - steps to take.
• Monitoring effectiveness -- integration of corrective / preventive action.

The common technical dossier - guidance on writing the overviews and summaries

The webinar will address the compilation of Marketing Authorisation applications in the EU in accordance with the Common Technical Dossier (CTD) format.

Areas Covered in the Webinar:

• Organisation of the CTD – comparison with old MAA and NDA formats
• CTD Summaries and overviews
• Quality Overall Summary (QOS)
• Nonclinical Overview and Summaries
• Clinical Overview and Summaries

Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?

This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.

Areas Covered in the Webinar:

• Overview of the drug development program and source of relevant submission documents
• Discussion of the roles and responsibilities for CTD preparation
• Review of the CTD format requirements
• Discussion on the successful transition from other formats to the CTD
• Implementing tools for the project management of CTD preparation and publishing
• Technical requirements for an eCTD submission
• Document naming requirements
• Building the folder structure
• Performing “pre-publishing” work for each document
• Tools for tracking and managing eCTD content
• Performing quality checks on the eCTD
• Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)

CMC Considerations for INDs and NDAs for 505(b)(2) Products

This webinar will highlight the key elements of the Chemistry, Manufacturing and Controls (CMC) section of an IND and NDA application for a 505(b)(2) product using examples and case studies. It will also discuss role of Drug Master Files (DMFs), and cross reference authorizations.

Areas Covered in the Webinar:

• The 505(B)(2) regulation and guidance from the FDA
• Strategic considerations for CMC section in a 505(b)(2) application
• Role of DMFs
• Best practices for using cross-reference authorization
• Common errors in CMC section in 505(b)(2) applications and potential solutions
• Examples of successful strategies for developing such products

How to write SOPs that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.

Areas Covered in the Webinar:

• SOP writing outline
• Content development
• The rationale for procedure use
• Regulatory compliance background
• Universal purpose of procedures
• The Human Perspective
• Human Error as a root cause
• The thinking and reading process
• Common mistakes and causes
• How to create and maintain a procedure
• Goals of a procedure
• Good Procedure Writing practices (Terminology, Formats, layouts, mixed cases, steps content, familiar words, references, branching, conditional steps, the use of “Precautions”, “Warnings” and “Cautions,”
• Procedure styles
• Use of electronic information networks for procedure access.

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