CR027 GCP and GVP Inspections and Audits

CR027 GCP and GVP Inspections and Audits

The GCP and GVP Inspections and Audits course is designed to provide an in-depth understanding of the regulatory requirements and best practices for conducting Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) inspections and audits. The course will cover the roles and responsibilities of inspectors and auditors, as well as the process for planning, conducting, and reporting on inspections and audits. Participants will gain knowledge on how to prepare for inspections and audits, including conducting a gap analysis and developing a corrective action plan. The course will also cover how to effectively conduct interviews and review documentation during inspections and audits. By the end of this course, participants will have a thorough understanding of how to maintain compliance with GCP and GVP regulations and guidelines and be equipped with the tools and knowledge needed to prepare for and successfully conduct inspections and audits.

Key Learning Points:
  • Audit VS. Inspection
  • Audit Plan and Design
  • Documentation Review and Analysis
  • How to Prepare for Audits and Inspections
  • Corrective Action and Preventive Action (CAPA), Follow-up and Closure
  • Common Inspection Findings
  • CAPA Plan development

Registration Fee: $995+HST (CAD)

CR027 GCP and GVP Inspections and Audits

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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