Inside CIS

People
Management Team
Subject Matter Experts

Features

Our CalcPartner service is staffed by GP experts, ensuring the integrity and compliance of your calculations.

PCX – SALES & MARKETING
PCX – Government Programs

Subject Matter Experts

Clarissa Crain
US Commercial Compliance
Clarissa Crain is a Director specializing in Commercial Compliance.

Clarissa’s background includes Corporate Compliance, Distribution Compliance and Government Programs Compliance. At CIS, Clarissa works with clients to develop comprehensive compliance programs with a focus in risk management and regulatory trends.
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Amy VanDeCar
US Commercial Compliance and Government Programs
Amy is a Director focused on Commercial Compliance and Government Programs.
In the pharmaceutical industry, Amy has worked as a consultant in the areas of Commercial and Government Contracting, Government Pricing calculations and Compliance. She has a proven background in data analysis, documentation, and systems implementations. Her industry experience includes chargebacks, membership, Government Pricing calculations, and Business/Pricing Analysis of Commercial and Government contracts. Amy has worked with branded, generic and biotech manufacturers at companies both large and small.

Amy currently concentrates in Government Price Compliance. Her expertise includes Class of Trade development, validation, and maintenance; calculation and procedural audits; policy and procedure review and/or development and Government Programs compliance assessments. Amy’s background as a GP analyst, a system implementer, and an auditor provides a strong foundation for understanding the compliance needs of manufacturers.
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Christina Spicer
US Commercial Compliance
Chrissy Spicer is a Director specializing in Commercial Compliance.
Chrissy works with CIS clients to conduct compliance assessments, and collect a solid understanding of their documentation requirements. In addition, Chrissy currently helps clients define and streamline processes so procedures can be standardized and documented. Chrissy is responsible for developing client specific processes related to policy and procedure documentation, managing documentation change control and monitoring and auditing. Additionally, Chrissy assists with defining system user requirements and supporting system implementations. Chrissy has earned a BS in Management Information Systems and Accounting at Drexel University and an MBA from St. Joseph’s University.
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Venessa Piper-Givler
Global Pharmaceutical Manufacturing and GMP
Venessa is the Director, Global Manufacturing Compliance.

Over the last 15 years in Pharmaceutical Manufacturing, Venessa has worked as a Director of Quality, Quality Assurance Manager and Quality Control Supervisor. She has had the responsibility of overseeing the Quality Assurance, Quality Control and Regulatory Affairs Operations at two manufacturing sites. She has a diverse experience in final dosage manufacturing, biotechnology, sterile drug product manufacturing and active pharmaceutical manufacturing. In addition, Venessa has led several FDA inspections as well as hosting several other regulatory bodies. Other experiences include managing global harmonization projects and implementation of electronic systems that are compliant with 21CFR.

In addition, Venessa is certified in Root Cause Analysis and CAPA systems, Auditing, as well as Design Excellence.

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Judy Fox
US Commercial Compliance
Judy Fox is a Director specializing in Commercial Compliance.
In the past 10 years, Judy has amassed diverse experience in the pharmaceutical industry in the areas of Compliance, Regulatory Affairs, Commercial Operations, Quality Assurance and Inventory Management. In addition, Judy has lead CIS’s PDMA and State Reporting services offerings. Her strong negotiation, oral and written communication and inter-personal skills allow for an easy transition between projects and clients and across a broad range of disciplines within the pharmaceutical industry. She is currently working with clients across several projects including system validations, vendor audits and program implementations.
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LISA C. MCNAIR
TRICARE Contracting
Lisa McNair is a Senior Manager.
A certified pharmacy technician with more than 18 years of pharmaceutical industry experience, Lisa assists CIS’ pharmaceutical manufacturing clients by offering insight into the mandatory task of recalculating and submitting payment for retro-active TRICARE liabilities. During her time as a pharmacy analyst working with the Department of Defense (DoD), McNair was instrumental in assisting with the development and implementation of the DoD/TRICARE Retail Refunds Program and the TRICARE Pharmacy Benefit Program. She possesses a diverse portfolio featuring excellent key relationship management, project management, and pharmacy program implementation. She has served as a compliance manager, quality assurance specialist, and business training manager.  
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Karen Agama
US Commercial Compliance
Karen Agama is a Senior Project Manager.
Karen has sixteen years experience in the pharmaceutical and biotechnological industries, spanning Government and Commercial Contract Operations, Sales and Marketing analysis and Sample Accountability. She has consistently incorporated compliance with Government requirements, industry standards and best practices into each of these roles, collaborating on process redesign; systems testing, implementation and integration; leading class of trade validation efforts; and conducting data, systems and Sarbanes Oxley audits. Policy and standard operating procedure (SOP) development and documentation, document control and training and educating others have been integral to Karen’s fulfillment of her responsibilities in each functional area.
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beth kline
Global Clinical R&D
Beth Kline is a Project Manager where she manages the Clinical PCX, client projects and provides research and reports on compliance and business process needs in Pharmacovigilance.

Over the last 12 years, Beth has provided sponsor management of clinical trial sites, implemented new safety systems, conducted training needs assessments and developed compliance training materials. In addition, Beth has effectively managed cross-functional project teams and clients.

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Dana Zelig
US Commercial Compliance
Dana Zelig is a Senior Specialist.
Dana received her undergraduate degree from Wake Forest University, and began her career as an Internal Auditor for Wachovia Corporation. In addition to her Internal Audit experience, Dana worked in the Worldwide Regulatory Affairs department at Wyeth Pharmaceuticals prior to joining CIS. As a Senior Compliance Specialist, she works with the GP team to perform audits, assessments and recalculations for CIS clients, and is currently providing testing and monitoring services for a top ten manufacturer. Dana is also the Editor of the Pharma Compliance Blog (PCB), and Module Manager of the GP Pharma Compliance Exchange (PCX), an authoritative online compliance library that keeps clients up to date on the ever-changing laws, regulations and guidelines affecting Government Pricing calculations.
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Lauren A. Pellicciotti
US Commercial Compliance & Government Programs
Lauren Pellicciotti is a Project Manager.

Lauren has a broad range of business experience within the Government Pricing arena, both as a consultant with IMS Health and as a Government Pricing Specialist with Teva Pharmaceuticals. However, Lauren started her career with Johnson & Johnson Pharmaceutical Research and Development (PRD) working as a Finance Co-Op in the Business Operations group. Working at J&J PRD sparked Lauren’s interest to continue her career path in the Pharmaceutical sector.

Lauren has developed policies and procedures for all price types and has been exposed to several recalculation projects. Lauren’s responsibilities have included calculating government price points for both generic and brand pharmaceutical companies, implemented best practices for source system reconciliations, conducted internal audits surrounding sample compliance, and assisted in educating her peers and outside client’s potential impacts of the 2005 Deficit Reduction Act (DRA) final rule.
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Yasmeen Muhammad
Global Pharmaceutical Manufacturing and GMP
Yasmeen Muhammed is a Senior Consultant.
During the past nine years, Yasmeen has worked as a Quality Assurance Associate, Quality Control Lead Chemist and Quality Control Analyst. She has worked at two manufacturing sites where she gained quality experience in GMP and GLP practices, data review, document control, batch record review, change control, SOP writing, training, investigative writing, CAPA's, as well as FDA Inspection Readiness. Yasmeen is also certified in the 5S Lean System and Root Cause Analysis.

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ERICA BROOKS
Global Pharmaceutical Manufacturing and GMP
Erica Brooks is a Senior Compliance Manager.
During the last 15 years in Pharmaceutical Manufacturing, Erica has worked as Quality Control Manager, Technical Facilitator, a Quality Control/Assurances Supervisor, and an Analyst. She has had the responsibility of leading the Quality Control Laboratory. She also has Quality Assurance and Regulatory Affairs Operations experience at three manufacturing sites. She has a diverse experience in Final Dosage Manufacturing and Active Pharmaceutical Manufacturing. She has managed and sponsored Global Harmonization projects and Site Lean Manufacturing Projects.

In addition, Erica is certified in Root Cause Analysis and CAPA systems, as well as Lean Manufacturing, Six Sigma, and Design Excellence.

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