AUD4010 Advanced Auditing (Level II)

AUD4010 Advanced Auditing (Level II)

This advanced course provides an in-depth examination of pharmaceutical auditing for individuals working in the life sciences industry. The course is designed to address the need for a working knowledge of auditing principles, techniques, and methodologies in a highly regulated industry. The course will cover topics such as audit planning and preparation, audit techniques and methodologies, documentation and record-keeping, and corrective and preventive actions (CAPAs).

Through lectures, case studies, and interactive discussions, students will gain a practical and comprehensive understanding of the audit process, including conducting complex audits, interpreting audit findings, and implementing effective CAPAs. The course will also cover advanced topics such as risk management, data integrity, and supplier auditing.

Students will have the opportunity to develop practical skills through hands-on exercises and simulations, including conducting mock audits and presenting findings to a panel of experts. Graduates will have a strong understanding of how to design, plan, and conduct effective audits, including the ability to evaluate risks, identify compliance issues, and develop and implement effective CAPAs.

Upon completion of the course, graduates will have a thorough understanding of pharmaceutical auditing and will be able to perform their job responsibilities confidently.

Learning Points:

  • The QA unit responsibilities and internal audits
  • Regulatory inspections
  • Audit of document management system
  • Audit of change control process
  • Most common observed deficiencies in the change control process
  • Investigation of deviations and incidents reports
  • Audit of validation of utility systems
  • Auditor’s review of water and HVAC systems (CBER guidelines) for inspection of water systems
  • GMP requirements for segregation of operations.
  • Audit of materials, product, waste and personnel flow
  • Auditing of aseptic operations
  • Supplier audit and vendor qualification program
  • Biological starting materials audit
  • Auditing microbiological laboratories
  • Quality control, analytical, and research and development laboratory audits
  • Auditing of contract manufacturers
  • Environmental Monitoring program.
  • Audit of the stability program
  • Audit of the complaints system
  • Product recalls process audit

This course is suitable for individuals who have a basic understanding of auditing principles and are looking to expand their knowledge and skills to advance their careers in quality assurance, quality control, or regulatory affairs in the pharmaceutical, biotech, or medical device industries.

Registration Fee: $920+HST (CAD)

AUD4010 Advanced Auditing (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