Technical Writing
What you'll gain from this course
Ensure success within Manufacturing and Supply operations through well‑written documents prepared by all team members. Whether you have to create new instructions or change controls, complete deviation and investigation reports, or respond to inspection observations, clear and concise communication is crucial.
This course equips you with the skills to write technical documents that meet regulatory expectations – quickly, accurately, and audit‑ready.
Key Features
- Boost your professional confidence: become the go‑to expert in writing and reviewing regulatory documentation
- Save time and avoid rework: write clear, concise and coherent reports the first time
- Protect your organization: ensure regulatory submissions are accurate and defensible
- Build trust with regulators: confidently structure professional responses to Requests for Information and inspection findings
Course Tutor
Rob Hughes – Rob is a seasoned expert with decades of global experience in Quality Assurance and Regulatory Compliance. He has led Operations and Development QA organizations across the US, UK, Sweden and India. He established global PQS processes and standards for authorised product supply chains and set QA/GMP standards for API and product development across multiple sites for worldwide registration and supply.
Rob served as an integral member of the corporate Quality & Compliance Leadership Team covering all stages of the product lifecycle. Importantly for this course, Rob directed Quality Assurance and Dossier Management Operations, overseeing global QA standards and post‑approval regulatory dossiers. He chaired technical issue management and recall decisions worldwide, with full responsibility for all global recalls.
Learn from someone who’s been at the heart of regulatory decision‑making for a major operation.
Learning Outcomes
- Apply the key principles of technical writing – the 7 Cs of Technical Writing
- Critique poorly written PQS documents
- Understand procedures, change controls and deviations
- Create best‑in‑class written communications to regulators
- Develop responses to inspection findings and Notification of Defective Medicines
- Prepare regulatory submissions
Who Should Attend
Essentially, anyone whose role requires clear, concise and compliant written communication in a regulated environment.
- Manufacturing and Operations team members
Those involved in documenting processes, deviations and corrective actions. - Quality Assurance (QA) and Quality Control (QC) professionals
Those who frequently write or review deviation reports, change controls and responses to regulatory findings. - Regulatory Affairs specialists
Those who prepare and review submissions and need to ensure documents meet compliance standards. - Validation and Engineering teams
Those who produce technical reports that must be audit‑ready. - Supply Chain and Logistics personnel
Especially those who handle documentation for recalls or inspections. - Anyone involved in responding to regulatory inspections or audits
Including managers who write, review and approve documentation.
Need help choosing?
Our training advisors can help you find the perfect match.