Christopher Holshouser has over 25 years of experience in quality assurance for the pharmaceutical industry. He has held roles such as Director of Global Quality Assurance and Director of Laboratory Quality. Holshouser has expertise in areas such as GMP training and auditing, FDA inspections, process validation, and quality systems. Currently, he owns a consulting business providing quality services to pharmaceutical companies.

1. CHRISTOPHER L. HOLSHOUSER
PO box 16478
Wilmington, NC 28408
(910)262-8316
holshouser@gmail.com
EDUCATIONAL BACKGROUND
B.A. Chemistry May 1983
Catawba College
Salisbury, NC
Statistical Process Control Certification February 1987
Rowan Technical College
Salisbury, NC
EXPERIENCE
A Quality Assurance professional with more than 25 years of experience with “big pharma,”
small pharmaceutical “start-ups,” and the contract manufacturing (CMO) and clinical research
(CRO) service businesses including global chemistry, manufacturing and controls (CMC)
services, and QA consulting. Also has hands on experience with FDA site inspections, analytical
method validation, process and cleaning validation, Quality by design, and product development
strategies for new chemical entities and generic drugs.
PROFESSIONAL WORK HISTORY
GH Quality Consulting
08/14 to present Owner of GH Quality Consulting
Provides Quality consulting, training, and auditing for commercial and development in the
pharmaceutical industry. Over 25 years of experience and expertise in the following areas:
 FDA and EU compliance regulations for APIs and finished products
 GMP Training and Auditing
 FDA site inspections
 Problem Management and Resolution (Field alert, Recall, 483 response, Warning Letter)
 Root Cause Analysis / CAPA / Trending
 Process Analysis / Continuous Improvement
 Risk Management
 Technical knowledge in CMC operations
 Business Development and Client Relations
 Knowledge of global clinical report requirements
 Technical knowledge in Clinical Trial testing and data analysis

2. Osmotica Pharmaceutical
04/06 to 01/14 Director of Global Quality Assurance
Directed the Quality function for the global operations, overseeing the harmonization plan across
all sites. Directed the implementation of cGMP / cGCP compliance globally through auditing /
consulting of manufacturing suppliers, vendors, and CROs. Directed the Quality globally, for
development, transfer and production of products submitted in Osmotica Regulatory filings.
Directed the Quality of all contract manufacturers and help resolve any production Quality
issues. Directed the Quality release of all in-licensed products globally. Directed the
management of the Quality budget for facilities in Buenos Aires, Argentina, Marietta, Georgia
and Wilmington, North Carolina. Directed the review and approval of all clinical documents
such as protocols, case report forms, deviation and violation reports and clinical reports.
Directed the Clinical Quality for all clinical studies being performed globally.
AAIPharma, Wilmington, NC
07/04 to 03/06 Director of Laboratory Quality
Directed the Quality function in the Wilmington, RTP, and New Jersey facilities for the
analytical laboratories in support of R&D, Manufacturing and Fee for service businesses.
Performed review of SOPs, investigations, deviations, training, out of calibration notifications
for the analytical laboratories at these facilities. Directed the Quality functions for the
bioanalytical and analytical functions at the Kansas City, Kansas and Neu Ulm, Germany
facilities. Directed a Quality staff of six people.
02/04 to 07/04 Director of Process Improvement
Directed the on-going and up-coming projects to improve processes at aaiPharma. Interacted
with all departments to initiate improvements to appropriate areas. Provided feedback to upper
management as to the progress and success of each project up to and after completion.
Responsible for assuring that the appropriate areas were addressed to insure the maximum value
added for the time spent on the improvements.
Endeavor Pharmaceuticals, Wilmington, NC
04/01 to 1/04 Manager of Quality Assurance
Directed the Quality function for the development, production, and approval of all products
produced by and for Endeavor. Performed auditing of any vendors or contractors used by
Endeavor to assure regulatory compliance. Directed the contract service providers in the
development, manufacturing and testing of Endeavor products to ensure compliance with FDA
guidelines. Performed review of development, manufacturing, and testing documentation and
make final approval for distribution of product. Consulted both internally and externally on
any issues regarding development, manufacturing, and testing of Endeavor products. Reviewed
clinical documentation such as protocols, clinical trial data, and final clinical reports to
facilitate the submission of data to the FDA.

3. AAI, Wilmington, NC
08/99 to 04/01 Manager, Document Quality Control
Performed auditing/consulting for external clients, both national and international, in such areas
as PAIs, Regulatory Submissions, Vendor Qualification, and Clinical Trials. Responsible for
overseeing government regulatory agency audits, (FDA, MCA), and assure any issues are
addressed adequately. Corresponded with FDA on compliance issues such as Part 11, IQ/OQ,
Aberrant data investigations, and Process validation. Worked with Research and Development
to facilitate batch record generation and review. Responsible for managing and participating in
the review and approval of cGMP documentation (i.e. SOPs, Specifications, Laboratory
investigations, Validation Protocols, etc.) and the archival of that documentation. Responsible
for managing the implementation of the Nova Manage electronic document control system.
04/98 to 08/99 Associate Scientist, Quality Assurance
Conducted internal audits of company operations including formulations, analytical, biotech,
microbiological, manufacturing, stability, regulatory, clinical, archives, purchasing, invoicing,
warehousing and child care for compliance with appropriate regulations (FDA, DEA, OSHA,
etc.) and AAI SOPs. Facilitated regulatory and customer audits of AAI operations. Conducted
audits of vendors and subcontractors on behalf of AAI and clients. Maintain a database of
observations for analysis and assessment of AAI quality. Member of global quality team to
assure compliance with US regulatory standards by AAI facilities in Europe. Quality consultant
for mock-PAIs and GMP audits of manufacturing and formulation development projects.
01/97 to 04/98 Supervisor II, Quality Assurance
Supervised the daily GMP auditing of the laboratory facility. Supervised and participated in the
consultation of lab personnel to resolve laboratory issues. Audited and reviewed method
development / validation data as well as routine laboratory data.
10/93 to 01/97 Associate Scientist, Quality Assurance
Performed daily GMP audits of the laboratory facility. Worked with laboratory personnel to
investigate and troubleshoot issues. Reviewed and approved specifications,
equipment/computer validations.
Proctor and Gamble, Greensboro, NC
10/89 to 10/93 Analytical Chemist
Performed as lead technician for the Analytical QC Lab. Performed review and approval of
bulk product batch records as well as qualitative and quantitative analysis of raw materials, and
bulk and finished product using wet chemistry, HPLC and GC methodology to comply with
USP, BP, EP regulations. Also performed PM, calibration, and repair of laboratory
instrumentation and monthly GMP audits of the laboratory.

4. Stanback Co., Salisbury, NC
10/86 to 10/89 QA/R&D Manager
Designed and maintained QA/QC system for company. Conducted annual GMP training for all
personnel. Performed formulation and development of OTC products and line extensions.
Rowan Memorial Hospital, Salisbury, NC
03/79 to 10/86 Laboratory Medical Technician
Rotated through the following departments of the laboratory performing routine clinical
procedures: Phlebotomy, Hematology, Blood Chemistry, Serology, Microbiology, Cytology,
and Histology. Reviewed and reported final results to the doctors. Responsible for ensuring
that proper paperwork was on file for all patients receiving laboratory procedures.
REFERENCES
Available upon request