This course provides a comprehensive understanding of Chemistry, Manufacturing, and Controls (CMC) in the pharmaceutical industry, including the product life cycle, manufacturing processes and controls, analytical procedures, and regulatory requirements.
Students will learn about the pharmaceutical product life cycle and the role of CMC in each stage of the cycle. The course will cover the manufacturing processes and controls involved in the production of pharmaceutical products, including the development and validation of manufacturing processes and the management of manufacturing changes.
In addition, the course will address the analytical procedure sections of pharmaceutical products, including method development and validation, and the importance of analytical testing during the manufacturing process.
The course will also cover the International Conference on Harmonization (ICH), the Common Technical Document (CTD) Quality Overall Summary (QOS) and CTD Module 3 requirements overview. Students will gain an understanding of the requirements for CMC submissions, including the structure and content of CMC documents and the importance of compliance with regulatory guidelines.
Furthermore, the course will provide a detailed overview of the full ICH stability storage and testing requirements for pharmaceutical products, including the requirements for stability studies, storage conditions, and testing intervals.
Learning Points:
This course is ideal for students interested in pursuing a career in pharmaceutical manufacturing, regulatory affairs, or related fields. The course is also relevant for professionals working in the pharmaceutical industry who want to expand their knowledge of CMC and its impact on drug development and commercialization.
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
