The course outlines technical and regulatory aspects of clinical study documentation handling and SOP development. Students will learn how to organize the documents and run regulatory and clinical study administratory communication, write technical and research reports, letters, and other documents.
The course will cover the various components of an SOP, including purpose, scope, responsibilities, procedures, and documentation. Students will learn how to develop and implement SOPs that are compliant with GCP and national guidelines.
Students will learn how to write and manage different technical, business and scientific documents, research reports, and letters applying the principles of Good Documentation Practice (GDP). The course also approaches several language, structure, style, and content issues in technical writing. Students will also learn about the clinical research quality objectives, quality requirements, and quality systems.
Upon completion of the course, students will have a comprehensive understanding of clinical research SOP development and will be able to apply this knowledge to real-world situations in the clinical research industry. They will also be able to develop effective SOPs that meet regulatory requirements and ensure the safety and well-being of study participants.
The instructors are industry-experienced in a supportive learning environment. Field-related internships give students real-world experience. Students also receive ongoing job search assistance and career services from AAPS.
Sedigheh Fadaye Vatan
Pharmaceutical Quality Assurance and Regulatory Affairs Graduate
Taking the AAPS Cannabis Management, Quality & Laboratory course was the one of the best decisions for my career. They are all extremely knowledgeable in their field, with real life experiences to share.
Orenda Von Gernet
Cannabis – Management, Quality and Laboratory Graduate
I enrolled in the QA/QC program and midway through the program I successfully landed a 6-month internship at Teva Pharmaceuticals. Upon completing my program part-time, I got a full-time position with PerkinElmer.
Lukman Nahle
Pharmaceutical Quality Assurance and Quality Control Graduate
I am very happy that I chose AAPS as my next academic endeavor after graduating University. The course was very useful in teaching me the things that I will need to know when entering the Cannabis industry.
Zachary Petkov
Cannabis – Management, Quality and Laboratory Graduate
Coming to AAPS to pursue my PG Diploma in CRDSP has been one of the best career decisions. I’ve received my offer letter to join as Project Management Associate at Axiom real-time metrics solutions, On.
Remya Pushparajan Subha
Clinical Research Graduate
The food safety and quality program at AAPS provided me with the knowledge required for the Canadian food industry. As a newcomer to Canada, I really appreciated the welcoming vibe the college offered.
Dania Hariri
Food, Technology, Safety and Quality Graduate
I was newcomer in Canada from Nepal. I enrolled in PG Diploma in Pharmaceutical QC/QA/RA course which i think was the best. After 3 weeks of hard work into co-op days, I was offered a full-time job.
Yushma Shakya
Pharmaceutical Quality Assurance and Quality Control Graduate
I am excited to share my employment news. I am now working as Quality Assurance Manager and I couldn’t have done it without your help and encouragement. I want to specifically thank all the AAPS instructors.
Abolfazl Darashti
Food, Technology, Safety and Quality Graduate
Thank you to everyone at AAPS for helping me in my postgraduate training. I am now really excited to be working at the McKesson Corporation (Fortune Top 500 Company) as a Health Services Case Manager.
Amjad Atrash
Clinical Research Graduate
I am happy to share that I have received a job as a Clinical Research Recruiter at BioPharma Services Inc. It was a hard and persistent job but I couldn’t have done it without the AAPS support.
Saeeda Hasan
Clinical Research Graduate
