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Attadale Partners, LLC Life Science Chief Executive Officer Forum a Q1 Productions Conference Jacksonville, Florida January 31-February 1, 2013
January 31, 2013 © Attadale Partners, LLC 2013 1 Attadale Partners is a management consultancy focused on enhancing our client’s competitive position through the improvement of operational and management process. Who Are We? Our clients are some of the most accomplished and successful organizations in the world. They demand experience, insight and tangible results from their consulting partners. This is why they choose Attadale and why we enjoy an envious client retention ratio.
January 31, 2013 © Attadale Partners, LLC 2013 2 Serving The Healthcare Value Chain Pharmaceutical Medical Device Quality Management Systems Complaints, CAPA, Validations Healthcare Provider Competitive Analysis Direct to Consumer Healthcare Payor Operational Efficiency Customer Value Analysis
January 31, 2013 © Attadale Partners, LLC 2013 3 Quality Management Systems (QMS) Are Critical Data confirms that the most frequently cited 483 observations were for lack of adequate procedures for Corrective and Preventive Actions (CAPA) (#1) and Complaints (#2) Data confirms that there is a heavy emphasis on complaint handling for the drug sector, although not top two box Does not appear to be any changes in approach – CAPA and Complaints remain key inspection areas FDA is still using the QSIT approach so will continue to examine entire Quality System as a routine Smaller-medium firms may not be aware of the complexities of meeting cGMP CAPA & Complaint requirements if they do not follow warning letter activities on a regular basis Quality Management Systems serve a vital role in the effective and efficient management of a Pharmaceutical or Medical Device company. In addition, a well designed and management quality system is critical for Agency audits. FDA 2012 Turbo data
January 31, 2013 © Attadale Partners, LLC 2013 4 Relevant Expertise Matrix Attadale staff bring cross-industry experience designing, implementing and managing Quality Management Systems (QMS) within life science and other industries. In addition to QMS experience, we maintain operational certifications supporting the efficient and successful implementation of large-scale, global change programs. Quality Certification ExperiencecGMP Industry Experience Operational Certifications ISO 9001 Complaints Process Medical Device PMP Certification TS 16949 CAPA Process RSU Device6σ Green Belt A-SPICE Validation Process Pharmaceutical6σ Black Belt HACCP Tier I & II Automotive Supplier Current active project or a project completed in 2012
January 31, 2013 © Attadale Partners, LLC 2013 5 Sample Life Science Projects Developed global Complaints Management model and designed detailed implementation plan Design Validation Management Tracking process, including requirements for a software tool, and manage global deployment Lead the process for the harmonization of 3000+ quality documents in a merger integration initiative Analyze the operational and financial impact of insourcing or outsourcing of global payroll, and develop recommendations and next steps Developed the future state process and RFI/RFQ for the global installation of a new HR Management system. Design organization structure for the Quality department for a Medical Device manufacturer Analyze process, organization and functional requirements for a CAPA quality system for a Medical Device manufacturer Co-develop Quality strategic plan for medical device manufacturer
January 31, 2013 © Attadale Partners, LLC 2013 6 Guiding Principles Results driven. We partner with our clients to analyze, design and implement improvements in core business operations designed to increase operational efficiency, effectiveness and alignment with the corporate vision and strategy. Our recommendations drive results you can measure. Problem solvers. We understand that each client is unique and each engagement is different. We identify the commonality, acknowledge the difference and leverage our experience to solve problems by combining thought leadership, external practices and previous experience. This approach translates into quicker results. Focused. We are not everything to everyone. We focus on Insurance and Health Care (Life Science and Providers) industries. We are not auditors, nor system integrators. We focus on implementing organization, process and tools to help our clients realize their strategy and beat their competition. Independent. Attadale is member-owned, free from the constraints imposed by external stakeholders, enabling us to focus on the long-term. We maintain appropriate alliances for technical subject matter expertise, but are not contractually or financially in partnership with software or other solution providers. This means our recommendations are impartial and right for your needs, not our needs. Experienced. We understand experience and expertise are not the same – fortunately for our clients we have both and understand the difference. While Attadale Partners was founded in 2007, our staff average more than 20 years experience as both industry practitioners and consultants. This reduces our learning curve and broadens the quality of results for our clients. We believe our success is driven wholly by our clients’ success. We are selfless in the pursuit of the right answer – Client, Attadale, Consultant.
January 31, 2013 © Attadale Partners, LLC 2013 7 Select Biographies Geoffrey Colgan Mr. Colgan founded Attadale Partners in 2007 and currently serves as the Managing Partner for Attadale. Prior to founding Attadale, Geoff consulted to Insurance and Life Science companies as a Principle at Charter Consulting and in progressive roles with Gemini Consulting. Geoff worked in Insurance Operations with Sun Alliance Life Assurance in Australia, before coming to the United States. In addition to his Firm responsibilities, Geoff is a member of the Illinois Chamber of Commerce Healthcare Council, is Chairman of his children’s school board and is active in the Australian expatriate community. Geoff lives in Chicago with his wife and four daughters. Geoff received an MBA from the University of Notre Dame, magna cum laude, and a Bachelor of Economics from the University of Western Australia. Elizabeth Tanner Liz brings more than 30 years of business experience in Life Sciences. Liz’s focus has been on complaint management and Corrective and Preventive Action (CAPA) initiatives where she has been responsible for a major corporation’s global programs. Her experience in interacting with regulatory agencies from around the world gives her unique insight into balancing day to day business needs while meeting each government’s compliance requirements. Liz is recognized for her ability to listen to her customers needs and translate their requirements into sustainable working processes. Her expertise in interacting with clients from around the world results in strong working relationships and high credibility with her team and customers. Liz earned her BA from Mundelein College in Chicago. She was an active member of the Midwest Complaint Organization. Biographies
January 31, 2013 © Attadale Partners, LLC 2013 8 Geoffrey Colgan Office847.330.6310 Cell847.226.0067 Fax847.253.4671 firstname.lastname@example.org 10 N. Martingale Rd, Suite 400, Schaumburg, IL 60173 Experience. Operations. Success. Attadale Partners is a management consultancy focused on enhancing our client’s competitive position through the improvement of operational and management process. Elizabeth Tanner Office847.330.6310 Cell224.234.7646 Fax847.253.4671 email@example.com 10 N. Martingale Road, Suite 400, Schaumburg, IL 60173
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