How to improve your SOP writing, investigation reports, CAPA Reports, Summary Reports
Well writtenSummary reports, investigation reports, documents, technical SOPs help employees understand information the first time they read or hear it. Who doesn’t want to improve compliance, shorten induction time and reduce deviations caused by confusing procedures?
If you are asked to write SOPs as part of your job role, would you like some straightforward guidance on where to start and how to write? Are your documents caught in a cycle of endless revisions, taking months to gain approval after the review date? Do you find yourself slogging through convoluted language to extract the information you need? Are issues of Data Integrity causing challenges? Are you grappling with writer's block?
This training course has been meticulously crafted to address these concerns and enhance your skills in crafting clear and effective Standard Operating Procedures (SOPs), data collection forms, and various other documents.
By the end of the course, participants will have the ability to:
- Draft SOPs that offer unequivocal instructions.
- Develop data collection forms that prioritize Data Integrity.
- Create documents that are submission-ready upon the first review.
- Produce reports containing the precise and pertinent information needed.
Ultimately, the course aims to instill confidence in writing SOPs, data collection forms, and other
documentation that is not only easily comprehensible but also readily applicable.
Day 1 Content
- Pruning the ‘deadwood’
- Reducing complexity
- Using process mapping to structure documents
- Writing clear instructional documents (e.g. SOPs)
- Preparing data collection forms
- Writing concise reports
Day 2 Content
- Writing Effective Documents
- Identify the proper sequence of actions
- Employ consistency from document to document
- Construct an SOP in the appropriate format
- Hands-on Writing Sessions
- Using skills attained, create and/or edit SOP documents
- Write Investigation Reports (Deviations, CAPA, OOS reports)
- Design a SMART data Collection Form
- Effective writing of Summary Reports (Validation, Technical reports)
Participants
This course is suitable for anyone who writes or reviews workplace documents, whether you are new to this or have been writing for years. It covers fundamental principles of good technical writing as well as current trends in, and tools for, SOP writing. The applicability of this course extends beyond the life sciences industries to any business where documents play a fundamental role.
Format and Course Length
The course will be delivered as an online virtual-classroom training session.
Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.
The training will be delivered as 2 full day sessions with breaks.
PDF Certificates will be provided to participants electronically.
What Do I Need?
Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.
Sessions
| Sessions | Dates | Times |
| Day 1 | 5 September 2024 | 8:45am join for 9am-5pm |
| Day 2 | 6 September 2024 | 8:45am join for 9am-5pm |
Times are based on Singapore time (SGT): UTC +8:00.
Participants to join at 8:45am in advance of a 9:00am start to address any technical issues.
Fee
- SGD $1400 (excluding tax) per participant
- A 10% discount applies to 3 or more participants from the same company
Course Registration and Payment of Fee
To register, please contact Biju Kishor at biju.kishor@seerpharma.com.au
Contact us for clarification or to discuss your interest in this course.
