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ISO 9000 & AUDITS WORLD CONFERENCE ABSTRACT 

Total Integrated Performance Excellence System

Presenter:

Kevin Griffin, Sr., Quality Engineer, Management IQ, Albuquerque, NM, USA

Co-Presenter: Dr. Robert Ringer; Assistant Center Director-Quality Assurance; VA Cooperative Studies Program; Albuquerque, NM, USA

Keywords:

Integrated standards: 9001, 20387, 21500; MBPEA Framework; Regulatory (CAP, GCP, cGMP, TJC)

Industry:

Healthcare

Level:

Intermediate

The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (PCC) supports and manages drug/device, regulatory, and patient safety-related aspects of multicenter clinical trials (MCTs). MCTs study the effectiveness and safety of drugs/devices in humans. The PCC participates in more than 100 clinical trials, lasting from months to 15 years, with 2,500 clinical sites, 500-50,000 patients, using 250 drugs/devices. The PCC operates in a highly-regulated environment and thrives through visionary leadership, strategic planning, innovation, focus on customers, employee engagement, and systems approach. It implements the ADLI model into its total integrated performance excellence system (TIPES). The PCC benchmarks against contract research organizations (CROs), industry, and government and outperforms them on key measures of customer and employee satisfaction, engagement, and financial and market outcomes.

TIPES provides a solid foundation for PCC activities, creating opportunities for innovation and intelligent risk-taking in its pursuit of strategic objectives. PCC innovations resulted in improved web-based software systems for site inventory control, drug distribution, and patient randomization and treatment assignments.

Two new capabilities include the PCC’s biorepository for biospecimen storage and direct-to-patient dispensing; thereby expanding its offerings and providing the foundation for future growth. MBPEA examiners and VA visitors frequently note that the PCC does not operate like a government bureaucracy, but more closely resembles the private sector in its entrepreneurial approaches.

The proposed presentation describes use of multiple standards and tools to support improvement and high performance in the following key areas:

  • Using the ISO 21500 Guidance on Project Management to integrate ISO principles with pharmaceutical project management
  • Deploying a robust QMS through an established electronic QMS (used by all staff) that supports customer care, documentation and records, CAPA, management review, internal audit, equipment/calibration, and vendor management processes
  • Leveraging learning, visionary leadership, Lean teams, and an annual Strategic Planning Employee Empowerment Day to increase employee empowerment
  • Establishing a coordinated process to evaluate risk and change that engages staff in strategic and routine decision making. A discussion emphasis will address the recent creation of our state-of-the-art biorepository
  • Creating a project-oriented organization that emphasizes interlocking committees, communications, and measures/evaluations of effectiveness and improvement
  • Developing a benchmark organization - the PCC is the first VA entity to register to multiple ISO standards/guidance and receive the MBPEA. The PCC has hosted several Quality Learning Days for other organizations
  • Continually seeking new challenges by identifying key processes and matching them to existing standards for continuous improvement and internal/external validation, benchmarks, and best practices (Lean)

Even with its highly regulated processes, the PCC consistently outperforms a key benchmark of productivity, revenue per employee, when compared with top CROs. The PCC created a QMS model that directly address each of its key goods and services:

1. Pharmaceutical project management services for MCTs: ISO 21500; International Committee on Harmonization Guidelines for Good Clinical Practice

2. Drug manufacturing and primary packaging of drugs and devices: ISO 9001

3. Drug assays at its on-site biopharmaceutics/pharmacokinetics laboratory: ISO 9001; CAP accreditation

4. Randomization, treatment assignments, and inventory control systems design and programming: ISO 9001; ICH/GCP

5. Regulatory monitoring and auditing of clinical trial sites: ISO 9001; ICH/GCP

6. Design and operations of the new PCC Biorepository: ISO 20387

The PCC Leadership made an early strategic determination to validate its progress through voluntary examination by external agencies, such as ISO, CAP, NIST, Gallup, and Quantum. These examinations are in addition to mandatory audits by customers and multiple regulatory agencies (FDA, DEA, VA Office of Research Oversight). Our quality journey began in 1992; key milestones in this journey included:

1992: DEA registration
1993: FDA cGMP registration
1995: CAP accreditation
1998: ICH/GCP compliance
2003: Registration to ISO 9001
2004: VA Robert W. Carey Award recipient, Quality New Mexico Zia Award recipient
2009: MBNQA recipient; ICH/GCP External Gap Analysis
2013: Integration of ISO 21500 into the QMS
2018: Registration upgrade to ISO 9001:2015

PCC success is demonstrated through re-certification to the ISO 9001 standard since 2003 and as recipient of the MBNQA in 2009. ISO 21500 has been integrated into the annual external ISO re-registration and surveillance audits. In 2018, the PCC began more formally integrating ISO 20387.

REGISTRATION OPEN 
Please select the relevant Registrant Type from: a) Conference & Workshops; b) Exhibits & Sponsorship; c) Speakers & Co-Speakers

SPEAKERS' CORNER
Submit your PowerPoint by
January 31, 2019
Speakers’ Orientation Meeting:
Sunday, March 10, 2019, 6 PM-7 PM
Please download the Speaker Instructions here

Conference Chair's Message

Robert Freeman

The 2019 ISO 9000 & AUDITS WORLD CONFERENCE is focused on providing you and your organization with the information and tools needed to continue this drive toward excellence. This year’s conference will not only continue to prove relevant topics with leading experts in their respective fields, but it is.....read more