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Pharm-Olam Audit Academy

Delivering Accredited Competency in Clinical Research Auditing 

Program Details

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Pharm-Olam is changing the way that companies in the pharmaceutical industry handle audits and the training of auditors. We developed our accredited Audit Academy to eliminate duplicate efforts in auditing and help the companies involved save time and money by standardizing the audit process.

 

An auditor trained to an accredited standard provides a foundational competency to their organization. From a supply chain perspective, this gives me assurance.

- Dan BurgessChief Compliance Officer, Pharm-Olam 

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Become a Certified Auditor

Audits are a standard part of the pharmaceutical and CRO industries, but the quality of the control systems in place had not been consistent. Pharm-Olam systematized that process. Our Audit Academy program has been accredited through collaboration with the International Accrediting Organization for Clinical Research (IAOCR) resulting in an opportunity to achieve the status of Internationally Qualified Clinical Research Auditor. As such, Pharm-Olam are the authority for auditor competence in the pharmaceutical CRO industry. 

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Added Value

Qualified Pharm-Olam vendors who employ an Internationally Qualified Clinical Research Auditor are enabled to implement direct compliance reporting to their customers. This can improve a customer's ability to maintain oversight and facilitate lowering the overall cost of quality. Being an Internationally Qualified Clinical Research Auditor allows global recognition. A qualification which establishes your competence through knowledge, expertise and experience within the multi-faceted field of audit. 

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Our Training Program Methodology

Aligned to competencies which require trainees to demonstrate the ability to: 

Operate within a well defined Quality Management System (QMS)
Perform audits through strategic planning, conduct and reporting phases
Apply the appropriate regulatory requirements
Promote quality assurance through effective audit finding identification and closure through case management

Program Details

While leveraging existing experience, the program runs over a 12-week timeline with approximately two hours of contact per week; inclusive of live theory sessions, knowledge assessments and immersive evidence-based simulations.

The practical training:

  • Completion of an audit simulation which requires you to do an exercise based on audit activities using mock data/scenarios.
  • There are 6 exercises in total
  • Each exercise takes between 30 minutes and 60 minutes to complete. Total time to complete = approx. 5.5 hours
  • When each exercise is completed and submitted for marking there may be the requirement for you to do some additional work to meet the required criteria for passing to the accreditation standard
  • You will have the option to do the simulation exercises after the 8 hours of theoretical training or you can do them concurrently with the theoretical training after the completion of the related topic, providing an expedited option.

The theoretical training:

  • 8 live interactive webinars
  • 1 webinar per week of between 1 and 1.5 hours each
  • An assessment of approx. 6 questions to be taken after each session on-line which take about 15 mins
  • You will have access to a recording to the webinar and the slides on-line after each session should you miss a session or want to recap on the content

The practical training:

  • Completion of an audit simulation which requires you to do an exercise based on audit activities using mock data/scenarios.
  • There are 6 exercises in total
  • Each exercise takes between 30 minutes and 60 minutes to complete. Total time to complete = approx. 5.5 hours
  • When each exercise is completed and submitted for marking there may be the requirement for you to do some additional work to meet the required criteria for passing to the accreditation standard
  • You will have the option to do the simulation exercises after the 8 hours of theoretical training or you can do them concurrently with the theoretical training after the completion of the related topic, providing an expedited option.

With certified training and recruitment across sectors, a diversity of knowledge is achieved which reinforces the foundations of a quality auditor. 

  Nate Martin, Vendor Manager, Pharm-Olam 

Join the Next Generation of Pharmaceutical CRO Auditors

Build a verifiable foundation of quality at your organization with the Audit Academy. To learn more, click here to read our brochure or sign up below. 

Program Costs

1 complementary seat to current qualified Pharm-Olam vendors and sponsors 

Base rate $1500; Academic rates are available 

Upcoming Dates

Cohort: 4th May 2020 – 24th July 2020 

 

Program Costs

1 complementary seat to current qualified Pharm-Olam vendors and sponsors 

Base rate $1500; Academic rates are available 

 

Thank you for your interest in Audit Academy. Registration for the May 2020 cohort has closed.