GMP2001 Intermediate –
Good Manufacturing Practices (GMP) Level II

GMP2001 Intermediate – Good Manufacturing Practices (GMP) Level II

This intermediate course provides an in-depth examination of Quality Management System (QMS) in the pharmaceutical, biopharmaceutical, and medical devices industries. The course is designed to address the need for a working knowledge of designing and developing a strong and compliant quality system. The course will cover topics such as Quality Assurance (QA) and Quality Control (QC) concepts, Quality Risk Management (QRM), and Quality by Design (QbD). Students will gain an understanding of the regulatory requirements and guidelines for QMS, including current Good Manufacturing Practices (cGMP) and ISO standards.

Through case studies and student workshops, students will develop practical skills in using quality management tools such as change management, failure investigation, laboratory control system, validation system, and stability program. The course will also cover process validation, equipment qualification, and cleaning validation.

Upon completion of the course, graduates will have a sound and applicable knowledge of QMS and will be able to perform their job responsibilities confidently. This course is suitable for individuals who have a basic understanding of GMP and are looking to expand their knowledge and skills in QMS in order to advance their careers in the life sciences industry.

Learning Points:

  • GMP compliance practice, law, and ethics
  • Health Canada and FDA guidelines
  • Regulation vs. guidelines
  • Quality system tools
  • Document Management System (QMS)
  • Batch records, SOPs, record of training, instrument logs,
  • Electronic records
  • Laboratory control and instrument maintenance and qualification
  • Retesting and OOS investigation
  • Analytical systems and procedures
  • Laboratory Documentation: SOPs, instrument logs, raw data, electronic records
  • Out-of -Spec, OOS/OOT reports, and failure investigation
  • Change control and deviation
  • Compliant stability system
  • Validation requirements, cleaning, process, and equipment validation
  • Sterile manufacturing
  • Complaints & ADR
  • Self-inspection program & third-party audits
  • Regulatory authorities audit process, expectations, and responses

Registration Fee: $895+HST (CAD)

GMP2001 Intermediate – Good Manufacturing Practices (GMP) Level II

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A Transformative Journey

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

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

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

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

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

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

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

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

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

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

Saeeda Hasan

Clinical Research Graduate