Writing for Compliance: Regulatory & GxP Writing for Life Sciences

In regulated life sciences environments, the quality of your writing can directly impact compliance, inspections, and patient safety. This course equips you with the practical skills to develop clear, concise, and audit-ready documentation while building a strong foundation in GxP writing principles and exploring emerging topics.

Whether you're new to regulatory writing or looking to sharpen your skills, you'll leave better prepared to produce high-quality documentation, reduce compliance risk, and make an immediate impact in your organization.

Program Details:

Length: 4 weeks

Time Needed

Four weeks of online learning (synchronous and asynchronous)
Approximately 16 total hours of instruction

Cost

MCPHS Alumni: $1,200 (Please email professionalstudies@mcphs.edu for your unique discount code)
Early Registration (by Dec 31): $1,350
Standard Registration (after Dec 31): $1,500

Program Roadmap:

Participate in the 5-module program over four weeks with a blended format designed for working professionals
Demonstrate ability to produce compliant, audit ready documentation, signaling job readiness and credibility, especially for early career professionals
Apply these skills within your current role or strengthen positioning for adjacent opportunities

Learning Outcomes

Apply core GxP documentation principles, including clarity, traceability, consistency, and audit readiness, to real-world writing scenarios.
Produce clear, structured, and compliant documentation across various formats, including SOP’s, deviations, CAPA’s, and regulatory content
Organize technical and operational information into effective, inspection-ready formats that support quality systems
Use AI and writing tools in regulated environments while maintaining data integrity, authorship accountability, and compliance standards

Who should enroll?

This course is designed for professionals responsible for writing, reviewing, or contributing to regulated documentation in life sciences environments and need to strengthen clarity, consistency, and compliance in their work.

Our students are:

Medical/Technical writing professionals
Quality assurance, manufacturing, and operations professionals
Regulatory affairs and regulatory operations professionals
Clinical operations and research professionals
Early career professionals in the life sciences

Curriculum

Module 1: Foundations of GxP Documentation and Compliance Writing
Module 2: Writing SOPs and Controlled Documents for Clarity and Consistency
Module 3: Deviations and Investigation Writing in Practice
Module 4: CAPAs, Risk Documentation, and Corrective Action Communication
Module 5: Regulatory Writing, Audit Readiness, and Responsible Use of AI

Faculty

Patricia Hernan Miller, MBA

Pat Miller is a pragmatic and strategic quality assurance and regulatory compliance professional with over 30 years of leadership experience in Pharmaceutical and Biotechnology GxP (GLP, GCP, cGMP, Quality Management Systems, Data Integrity, Inspection Readiness, computer system validation, and CAPA Management) and ISO certifications (ISO 13485, 9001). She has successfully developed and presented GxP compliance courses for internal company and industry organizations (including online training for the Society of Quality Assurance) and has contributed to multiple DIA and SQA publications. Pat earned her MBA from the Fuqua School of Business at Duke University, a Certificate of Pharmaceutical Law from Seton Hall, and her undergraduate degree with a double major of Psychology and Biology from the University of North Carolina at Chapel Hill.