Medical Device Management

Confidential Sep-**** Page * of *

Peter Ackerman

President and Managing Partner

Advanced Medicals Consortium, LLC

**** ********* **** *** #***, Ten Fortune Park, Indianapolis IN, 46268 1624 Vuelta Place Santa Fe, New Mexico 87501

10620 Treena Street, Ste# 230, San Diego, CA, 92131 Px: 866-***-**** Cx: 978-***-****

mailto:*****.********@**************************.*** Advanced Medicals Consortium, LLC

President and Managing Partner

March 2007 – Present

Consultant to the following companies: Ethicon, Cordis, International Bio-Resources (IBR), Talecris Biotherapeutics, Renovar, Tecan, SeetTek, Symbios Medicals, American Red Cross, 5D Information Systems, eTherapeutics, Life Technologies/Invitrogen, Roche Diagnostics, Beckman Coulter, Fisher & Paykel Healthcare, Anesthesia Safety Products, Exact Sciences, DePuySynthes (JnJ) & Amgen

Lead consultant implementing Change Management, Life Cycle Management, CAPA and Change Control methodologies harmonizing organizational strategy and goals departmentally within engineering groups for several biotechnology companies developing and commercialized Combination Products under remediation activities

Create, Implement and audit Design Control and Device History Files (DHF) processes, executing required corrections within biotechnology companies with commercialized Combination Products under remediation activities

Develop, implement and train organizations on FDA QSR 21CFR820 specifically on Design Controls (820.30), Production & Process Controls (820.75), Corrective & Preventative Actions (820.100), Post-Marketing Surveillance (21CFR822), Risk Management (820.30, ISO 14971, 31000), Software Verification & Validation ( 820.30, IEC 62304, IEEE 12207), Complaint Files (820.198)

Software Development Life-Cycle (SDLC) development, documentation, implementation and training of R&D staff, development and technical teams for class II & III medical devices, (IVDs, Implantables and Diagnostics)

Work with senior QA & Regulatory staff to develop, document, implement and train on risk management policies and procedures, Clinical SOPs and correspondence with Agency pertaining to regulatory submissions

Develop regulatory strategy for site during remediation efforts, leading and advising senior management with implementation. Prepared sites for Agency inspections through hands-on training, testing and internal inspections following QSIT & Compliance Policy Guidance

Advised Regulatory staff on pre-clinical and clinical processes and documentation in support of submission(s), Pre-IDE, PMNs, PMAs and DeNovo utilizing eCTDs and STED for submissions to Regulatory Agencies;

Develop and authored designation and supporting documentation for regulatory submissions, 510(k), IDE’s, PMA’s and combination products, for Agency & International Technical /Notifying Bodies required by medical device clients (FDA, MHRA, CMDCAS(SOR/98-282), MHLW);

Developed, trained and implemented multiple teams in Design, Process, Product and Service Failure Mode & Effects Analysis (xFMEAs) across the site. Developed and trained xFMEA leads for the site. Managing the overall steering committee for xFMEA

Lead multi-disciplined teams using PMBOK processes, both on and off site, with visibility to C-level management on $10Mln-$125Mln projects for class II & III medical device projects

Created and presented training courses/modules in xFMEA, Risk Management, Hazard Analysis, current Good Manufacturing Practices, Corrective & Preventative Actions, Auditing for inspections and Post-marketing Surveillance & Vigilance

Lead Auditor for cGMP inspections. Developed SOPs for Facility Inspections, preparation for EIRs and responses to Agency and Third-Party Audits. Scheduled internal audits, prepared teams, SMEs and senior leadership. Formatted: Not Highlight

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Liaison with Agency and Notifying Bodies during client inspections, Pre-meetings, Facility registrations, submissions and regulatory responses

Senior Project Manager for Global Remediation Project ($125Mln budget US & EU Facilities) Production & Process Controls, 21CFR820.70, Co-lead for workstream

Senior Project Management with start-up organizations leading QMS & PMO development, PM functions and Cost Analysis, Resource Management, Capabilities and Competencies Assessments, Interdependencies Assessments reported to SVP and C-Level stakeholders delivering project requirements to schedule

Specialized SVP & C-Level dashboards reporting metrics associated with advancing market position, resource management, budgets, capital expenditures and Balanced Scorecard

Develop regulatory strategy and classification for Product Registrations with USFDA

Super User with Sparta TrackWise, EDM Quality, LIMS and EtQ Quality (additional information available) Safis Solutions, LLC - Indianapolis, IN Director of Compliance and Quality Services (QA) Dec 2005 – March 2007

Senior Quality Assurance/Regulatory Affairs director responsible for managing change, assessing risk, and implementing regulatory strategy for clients in the life sciences industries (Biologics, Biopharmaceuticals, and Medical Device).

Developed and implemented regulatory strategies with clients Quality Management Systems (QMS) its development and implementation, to comply with FDA’s CFR 210, 211, 600’s, 820, 1270 & 1271, along with developing their Corrective and Preventative Action, Post-Marketing Surveillance, and Risk Assessment & Management procedures;

Sr. RA consultant for companies, developing design controls and design dossier for master design records, qualifying vendors and suppliers, change-control boards and design review, for preparing and submitting documentation(submission) to regulatory agencies and notifying bodies, including eCTD’s and electronic submissions;

Managed regulatory process with small start-up companies leading their strategy with FDA and achieving submission designation;

Developed and managed client relationships with senior staff and cross-functional teams with developing business, manufacturing and regulatory strategies to comply with regulatory bodies;

Directed and managed testing group (15 resources) for fortune 500 Biotherapeutics Company achieving Donor Management Software and National Donor Deferral Registry compliance prior to opening donor centers.

Managed a team of 5 technical resources developing quality & regulatory strategy and technical documentation for two Class II 510(k) submissions for a Proton Therapy center; SON Medical, LLC - Ashland, MA Director RA/QA Consultant August 2004 – March 2008

Senior Regulatory Affairs consultant, to ensure continual regulatory compliance with notified bodies requirements for clients.

Senior QA engineer provided engineering support during technology transfer process, design controls and with quality unit for testing verification & validation with fortune 500 Medical Device company;

Sr. SQA with Tecan USA validating In Vitro Diagnostics laboratory assaying equipment. Senior software quality assurance consultant for client’s validation & compliance requirements in both Pharmaceutical (Laboratory Analytics) and Medical Device (Class II IVD’s), including implementing SDLC processes for software development;

Lead ISO (9000 & 13485) compliance audits.

Developed CAPA & PMS policies and procedures for clients. Provide client support with entire validation & testing life cycle from requirements elicitation/review through User Acceptance Testing for compliance with various standards for verification & validation (21CFRp11), IOP/Q’s for equipment validation;

Lead analysis and compliance with Medical Device Directive 93/42/EEC for clients;

Reviewed and managed documentation packages for various regulatory submission and quality systems;

Business development analyst for medical device clients located nationally & internationally; Confidential Sep-2015 Page 3 of 5

Flexware Innovation – Fishers, IN Sr. Validation Engineer November 2003 – November 2005

Consulted for Eli Lilly & Company in Indianapolis providing software verification, validation & documentation support to their Parenteral plant and engineering groups (lyophilization, WFI, Laboratory Analytics).

Achieved compliance for companies manufacturing equipment (legacy systems & new equipment) within Lilly’s Parenteral plant and laboratory facilities;

Managed and completed several validation projects to Lilly’s master validation plan and deliverables;

Provide client support with entire validation & testing life cycle from requirements elicitation/review through User Acceptance Testing (following GAMP &SDLC) for compliance with various standards for verification & validation (21CFRp11);

Concurrently assisted as Senior SQA for medical device clients testing In-Vitro diagnostic test kits & assaying equipment (21CFR820), including 820.3- design controls laboratory assaying (IVD) equipment and Laboratory analytical equipment, following ISO 9001 standards and FDA (CLIA), ISPE (GAMP) guidance, IOP/Q’s for equipment validation;

Created, managed and submitted documentation packages for various regulatory and validation processes for laboratory quality systems;

Developed Software Life-Cycle (SDLC) controls for IVD manufacturing; MEDIcept Corporation – Boston, MA Sr. SQA & Validation Engineer August 2002 – November 2003

Regulatory Affairs consultant for medical device clients assessing agency compliance for Class II, IVD’s and QMS for CFR820 and ISO 9001.

SQA engineer for several start-up medical device companies, providing senior software quality assurance achieving verification and validation for class II, III devices and compliance with Medical Device Directive 93/42/EEC;

Senior software test engineer consulting for Level 3 communications provide testing verification, validation, and documentation support for the next generation of system scanners (Terminal, Airport, Baggage and Human), based on NRC compliance and regulations;

Business development analyst assisting medical device clients regionally & nationally; Advanced Digital Motion – Shrewsbury, MA Sr. Manufacturing Manager August 1998 – June 2002

Engineering manager leading software development, business management, and operational management for automation clients in multiple industries (Aerospace, Automotive, Medical, Sports Equipment).

Led internal software development, test & validation efforts for clients in manufacturing environments;

Managed development and implementation of CE marking process for manufacturing of cryogenic storage systems, in collaborations with BSI technical body;

Business development with clients locally, regionally & nationally;

Developed IQ, OQ processes for acceptance testing of automation equipment;

Developed, managed, implemented project management principles with sponsorship and charter through completion (I, P, E, C&M, C phases)

Automated Assemblies/ Nypro Medical – Clinton, MA Manufacturing Engineer June 1997 - August 1998

Assisted managing technical groups building high-speed precision robotic workstations for the automotive and medical device industries.

Established with technical groups standards for equipment manufacturing, testing and reliability following ASTM, IEEE, ISO standards

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Developed and implemented testing standards for electrical control panel, sub-assembly and finished equipment

Developed, managed and implemented quality standards in electrical & mechanical assembly departments, leading process improvements under six sigma processes Uromed Corporation – Needham, MA Manufacturing Engineer & Robotics Technician May 1996 - June 1997

Senior Manufacturing Engineering Technician, responsible for assisting in manufacturing processes for class II & III medical devices.

New Equipment verification & validation (IQ,OQ,PQ’s);

User Acceptance Testing;

Quality by Design processes in manufacturing;

Statistical methodologies for process improvements; Polaroid Corporation – Norwood, MA Manufacturing Engineer & Robotics Technician June 1992 - May 1996

Manufacturing Engineering Technician working with electrical, instrumentation and mechanical engineering teams in the development, implementation and process improvement of high speed precision robotic workstations used in manufacturing custom lens, camera, optical coatings, and circuit boards.

Trained and implemented six sigma and JIT manufacturing to internal customers

Trained and work on Total Quality Management team in Optics

Trained and implemented quality process for line robotic system (repair, replace, rebuild and customize) Certifications:

American Society for Quality, Certified Quality Auditor (CQA) Exp 12/2017 American Society for Quality, Certified Manger of Quality /Organizational Excellence (CMQ/OE) Exp 12/2018 Software Engineering Institute CMMI (Intermediate) leading to SCAMPI auditor (2012) Software Engineering Institute, Risk Management (Continuous) (2006, 2009, 2012) Total Quality Management (ANOVA, SPC, & Six Sigma) (1996, 2000) Training Forums:

AAMI S3 Challenge March 2014

Society of Quality Assurance (SQA) Risk Management for the GMP World, April 2008 American Society for Quality, (ASQ) Biomedical Midwest Forum 2007 /2008 Great Lakes Software Excellence Conference, Integration Testing November 8, 2007 IQAA, Quality Enrichment Conference, Integration Testing October 13, 2006 Professional Organizations (active memberships, workgroups & committees) Association for the Advancement of Medical Instrumentation, AAMI Association for Computing Machinery, ACM, SigSoft group American Society for Quality, ASQ (Midwest Biomedical Forum, Great Lakes committee, IndyASQ) Institute for Electrical and Electronic Engineering, IEEE Project Management Institute, PMI leadership and Project Management Regulatory Affairs Professional Society (RAPS)

ISACA (CoBiT) and ITIL

Professional Development

American Society for Quality, Software Quality Review RABSQA ISO 13485 lead Auditor, May 2011

Leadership training with professional business coach July 2011 Confidential Sep-2015 Page 5 of 5

The Institute for Risk Management 2008, 2010

Education

Stanford University Professional Certification in Strategic Decisions and Risk Management 2014 Brandeis University, Software Engineering, MS Program 2000-2003 Northeastern University, Manufacturing Engineering, BS Program 1991-1996

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