mary sg foster cv jan2015

Mary G. Foster, PharmD

100 Brochant Circle Cell: 267.246.7198 Blue Bell, PA 19422 E-Mail: [email protected]

PROFILE* Senior level Quality/Compliance/Regulatory professional with 30 years of experience in the pharmaceutical industry. Specifically,

* Quality/Compliance subject matter expert (SME) in CGMPS and regulatory agency guidance (multi-national); manufacturing operations including packaging and supply chain for oral solid, semi-solid and liquid dosage forms and sterile products. Application to human/veterinary, clinical trial materials and medical devices; NDA/ANDA, OTC monograph products and dietary supplements/food products

* Development and implementation of a global Quality Management System (QMS); worked in global application including USA, Canada, South America, EU, Australia and Japan; set up two laboratories from ground floor

* SME in global drug holding and transportation practices (collaborations with USA FDA, Health Canada, MHRA, WHO, and USP committees)

* SME in creation and execution of education programs for drug product CGMPs; trained regulatory agency staff: [e.g., FDA; ANVISA; NAFDAC (National Food & Drug Administration, Nigeria; Peruvian Ministry of Health;] and collaborated with industry partners on training programs (e.g., Sindusfarma; American Red Cross; Association Argentina Pharmaceutical & Biomedical Industry)

* SME in creating and maintaining compliant regulatory USA Drug Enforcement Administration (DEA) environment (Controlled Schedules I-V)

* United States Pharmacopeia (USP) work:* Council of Experts Executive Committee, USP 2010 – 2015; the body that oversees USP's scientific and standards-setting decisions

* Chair, USP 2010-2015 Expert Committee (EC) on Packaging, Storage and Distribution of Drug Product. USP Expert Committee member 2005-2010.

* USP Governance Committee, 2013-2015

* Represented USP in various worldwide conferences (e.g., US, Canada, Central America/Panama, SA/Brazil & Argentina, EU/Germany, India) on subjects such as CGMPs, validation, supply chain, laboratory controls and drug product integrity

EDUCATIONUNIVERSITY OF KENTUCKY, Lexington, KYDoctor of Pharmacy Program (PharmD awarded 1983)Bachelor of Science, Pharmacy

WESTERN KENTUCKY UNIVERSITY, Bowling Green, KYBachelor of Fine Arts

PROFESSIONAL BACKGROUNDCurrent since Aug 2014HealthCare Consulting: covering quality/compliance for pharmaceutical/biological manufacturing operations in multi-national setting with global regulatory agency interaction.

Aphena Pharma Solutions:08/1/2013 - 08/31/2013


PROFESSIONAL BACKGROUND (Continued)

Aphena Pharma Solutions (APS)Quality and Regulatory Consultant Transition out of work with Aphena due to restructuring process begun July 22, 2013

05/2011 – 07/2013Aphena Pharma SolutionsCorporate Vice-President Quality & Regulatory Affairs

Responsible for bringing five disparate businesses (manufacturing and packaging operations within the US) along with acquisitions under one quality management system including setting standard metrics and procedures; mitigating FDA Warning Letter potential based on 16 point 483 at one manufacturing site received Jan 2011, bringing one new green field site through first FDA inspection successfully in 2012; partnering with functional departments to ensure lean practices and financial expectations are met; and, acquisition and divestiture responsibility. Member of senior most leadership team reporting to the APS Board of Directors on quality and regulatory aspects of the business. Accountable for budget, associated CAPEX and monthly financial review with all sites. Responsible for integrating one manufacturing site acquisition based in NY during 2012; and, for closing one site due to restructuring in 2013.

Key accomplishments, 2 years and two months:*All six sites under one Quality Management System (QMS) with strong quality leadership teams and one standard set of job descriptions/titles for quality/regulatory staff. Set standard metrics and reporting process with consolidated overview for senior leadership review and decision making.*Standard procedures developed based on risk assessment (subjects to date: change control, management review process, CAPA, deviations, investigations, annual product reviews, training, risk management); standard metrics reported from floor (weekly) to APS senior leadership (monthly) to Board of Directors (quarterly).*Mitigation process for objectionable observations including local FDA office meetings and follow-up to closure for associated CAPA’s. *Green field start-up FDA inspection outcome of no 483 observations in Aug 2011.*Acquisition integration involving site with CII manufacturing process (inhaler).*Brought departmental headcount into balance and met budget every month to date.

Catalent Pharma Solutions11/2009 – 05/2011Vice-President Quality, Corporate Vice-President Quality and Regulatory, Packaging Services business unit, InterimTotal time at Catalent/CH/PCI/KP business from 3/1990 – 5/2011, (21 years)

Responsible for developing connections within the industry and world-wide regulatory bodies to ensure a continuous understanding and improvement process for quality processes within the global framework of the business. Covered regulatory agency interactions, meetings and interface including the following countries: USA, Brazil, Argentina, UK, Italy, Germany, Japan, and Australia. Responsible for supply chain network for quality / regulatory work including importation and exportation into countries around the world; and, including supply chain distribution such as those with the Fukishima event. Direct link with customers on quality and regulatory agency, including pharmacopeia, best practice development and strategic planning for the direction of the quality function. Responsible for the creation of a global cGMP education program.

Interim role covering quality and regulatory functions for the packaging and printed component business segment; eight sites, US and UK. Responsible for sustaining regulatory compliance across packaging sites and quality operations for printed component (labels, inserts, cartons) industry as a contract service provider.

Key accomplishments:

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*Represented Catalent around the globe in the following subjects: CGMPs, supply chain, laboratory best practices, clinical trial processes.*Key contacts created with all regulatory agencies engaged with Catalent; pharmacopeias including being elected Chair of one of 23 United States Pharmacopeia Expert Committees (a five-year commitment) and serving on other pharmacopeia chapter revision work teams on subjects such as excipients and soft gelatin manufacturing. *Created opportunities for Catalent staff to join working regulatory and pharmacopeia teams (e.g., soft gelatin manufacturing; sterile packaging practices); to work at academic settings (e.g., Xavier University and the annual contract organization conference)*Regulatory inspections, while staying steady at >50/year, resulted in outcomes with few sites receiving objectionable observations and few observations, (e.g. 2010: 51 regulatory agency inspections; 10 FDA with 5 483’s; no 483 >3 points; 10 DEA inspections with no letters of admonition).

04/2007– 10/2009 Catalent Pharma Solutions formed from Cardinal Health sale of PTS to BlackstoneVice-President Regulatory Compliance, Corporate

Global responsibility for providing company wide direction for key quality programs; for defining business unit and corporate risks and oversight of the mitigation process; and, leading corporate initiatives for continuous improvements including:1) Creating and maintaining the global Quality System approach for the corporation including creation and implementation of the Quality Manual of corporate Quality polices; standards; SOPs; development of a best practice’s Guidance Program; and site/business unit/corporate Position Papers. 2) Developing goals and measurements in alignment with company strategy. Trending regulatory compliance metrics and reporting risk analysis, including coverage of 35 sites world wide; industry trends; and regulatory agency documents/dockets and expectations. 3) Developing the appropriate quality compliance organization to assure goals can be successfully achieved and there is proper interface with all departments within the company. Producing a global annual Quality/Operations Conference to build alliances within the Quality and Operations staff; and provide forum for future. 4) Interfacing with regulatory agencies to ensure proper understanding of regulation and maintaining solid working relationships. Work with agencies to develop industry standards. Work with global sites in development of response to regulatory agency inspections.5) Creating the corporate auditing function including internal audits for CGMPs and DEA, regulatory inspection preparation programs, for cause audits; and the supplier audit program including AsiaPacific materials examination. 6) Working with sites to ensure quality systems are integrated across business units and where applicable across the company. Ensure areas such as technology transfer, CAPA and complaints are handled appropriately. Write a standard investigation program to support sites in correcting and preventing issues resulting from observations of customers; regulatory agencies; and corporate findings. 7) Designing the corporate Quality education program including training for CGMPS and DEA. 8) Oversight of new product ventures from a quality/compliance standpoint including risk assessments and where applicable, obtains legal strategy.9) Interface with varied industry issues such as bovine spongiform encephalopathy (BSE), transportation of product world wide, bioterrorism, anti-counterfeiting and the environmental management systems for various technologies relative to manufacturing operations.

Key Accomplishments:• Trend assessment on key quality/regulatory metrics led to improved compliance in 1) right first time batch

records; 2) no repeat field alerts/recalls; 3) deviations; 4) complaint processing; 5) CAPA’s and 6) reworks.• FDA Electronic Drug Registration Process: Maintain files of electronic submissions, US Agent, DUNS Numbers

for each Catalent site registered with FDA; Purchase and maintain Digital Certificate; Annual review of Importer data; Create or delete site submission for registrations with acquisitions or divestitures; Update Catalent FDA registration Webpage for sites documentation; Train sites to complete process for submission of FDA drug listing using the FDA electronic submission gateway (ESG). This includes the one Catalent site that owns FDA drug applications: St Pete.

• Regulatory Bulletin Communication Process: Create draft for all regulatory activity at sites. (inspections, field alerts, recalls); post data to the Quality Webpage”Regulatory Metrics”.

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• State Monitoring Program: all sites notified when any changes occur within any state; State gap analysis: coordinate completion and remediation work.

• Quality Web Site: Maintain, create, edit and modify contents of Quality Website and associated pages as needed.

• Maintained budget with all associated sites and corporate to forecast.

07/2003-04/2007Cardinal Health Inc, Pharmaceutical Technologies and Services (PTS) – Pharma manufacturing division sold 4/2007 and became Catalent Pharma SolutionsVice-President Regulatory Compliance, PTS Division

Worked directly with the biotech/sterile (sites within the USA and EU); oral (sites within the USA, sites in the EU, in Japan and in Australia); packaging (sites in the USA and sites in the EU); nuclear (>140 sites within the USA) and R&D (sites in the USA and sites in the EU) businesses to ensure regulatory cGMP and USA DEA compliance. These sites were involved in the discovery phase, clinical manufacture and packaging, commercial manufacturing and packaging and storage of finished products.

Responsible for developing site implementation plans to enhance regulatory compliance on a global basis across all PTS sites. These plans include education programs, quality system management initiatives and recommendations for continuous improvements relative to regulatory agency (experienced with federal agencies from USA; Canada; EMEA including: UK, Germany, Spain, Sweden, and Brazil) or customer feedback. Responsible for regulatory documents including federal registrations covering pharmaceutical manufacturing, packaging, (Form FDA 2656); Form FDA 2657 for labeling; and, Form FDA 3537 for the bio-terrorism act; This position is responsible for contact with regulatory agencies as necessary from the various sites.

Experienced in Drug Master File submissions for USA; and Site Master Files for world wide requests; regulatory applications including CMC sections for manufacturing, packaging and labeling data for own and customer NDA/ANDA as well as working with 510Ks.

This position is considered a senior management position and has significant decision making authority and responsibility and reports to the Sr. VP of Quality for PTS.

Key Accomplishments: • Improved regulatory agency profile within USA and EU for FDA inspections for all Catalent sites (32).• Developed action teams to complete strategy, including: regulatory compliance communication through-out the organization (Alert Program; Regulatory Reports and improvements to the Management Review Process in France and South America).• Team created guidelines on cGMP training initiatives such as effectiveness evaluations, trainer qualifications, and cGMP curriculums.• DEA team created a USA wide desk manual; training courses; common SOPs and an internal audit program. • USP Expert Committee work: Selected as USP representative for presentation to the Brazilian Pharmacopeia and industry; lead, with industry and FDA in my working group, on the re-write of the USP Chapter on repackaging; worked on chapters for container closure systems including a new chapter on glass containers.• Invited to teach FDA reviewers in Washington DC on packaging and labeling operations; fielded calls from FDA on opinion for various cGMP industry interpretations.• Presentations to various industry seminars including: 3-day Pharma Conference, was one of two non-FDA related personnel were invited to speak; instructor for 3-day CGMP education course presented annually in the USA and the EU.• Developed corporate policy on good electronic records management, bio-terrorism, BSE (for liquid gelatin products) and anti-counterfeiting for the organization.• Successfully worked with FDA on changes to various applications (CBE 30s) and justifications for the use of Annual Reporting over CBE submissions resulting in no FDA inspections.

08/95 – 06/03 PCI, Inc. - became Cardinal Health, PTS, Philadelphia, PAVice President Quality and Regulatory AffairsContract Services, Packaging and Printed Components

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This global business packaged and labeled prescription, OTC and clinical drug products as well as medical devices and vaccines. The original PCI business was sold to Cardinal Health in 1996. Responsible, in first year, of closing Richmond site from regulatory quality perspective and opening new site at Red Lion Rd in Philadelphia. Maintained old site in Philadelphia, K St, for 6 years until closing.Responsible for the USA and EU packaging and labeling sites (including sites in Philadelphia, IL, Puerto Rico, United Kingdom, and Germany). Responsible for setting up customer interface for quality at sites, including audits and quality agreements; the quality management systems for each site; project management of quality initiatives; regulatory inspections (including FDA, DEA, MHRA, and EMEA); quality council for packaging and labeling; education programs used globally; and advisory capacity for sales and marketing.

Key Accomplishments:• Set up laboratory for contract stability testing (FDA inspection yielded no Form FDA 483).• FDA inspections for all sites (8 sites) resulted in no Form FDA 483 observations from 08/95-06/2003.• Chaired NIH committee for packaging and labeling of AIDS product.• Developed quality policy manual for global sites.• Completed protocol testing for child safety effectiveness of various packaging delivery systems• Set up new product handling process with interface from Health & Safety dept.• Taught CGMP education seminar in USA and EU annually.• Attended Boston University Management program for Cardinal Health Senior management.

03/1990 – 08/1995Klockner Contract Packaging - became PCI, Inc, Richmond, VADirector Regulatory Affairs/Quality Assurance (highest level quality position)

This business was a contract packaging and labeling operation for the pharmaceutical industry. It was purchased by PCI in 1990, from the original owners, Klockner Contract Packaging, a division of Klockner Pentaplast. The site was closed in 1996 to consolidate the packaging operations to the new Philadelphia expanded office. Responsible for closing the site during the 1995/96 time frame. In 1996 Cardinal Health bought the PCI, Inc. business.

Responsible for the packaging and labeling operations of one site within the PTS organization. Supervised all regulatory and quality activities within the site and interfaced with all customer and regulatory visitors. Directly responsible for packaging and labeling validation efforts, the release of finished drug product to the customer and handled complaints and investigations. Worked on NIH committee for two sessions on the packaging and labeling of AIDS drugs.

05/83 – 03/90 Vangard Labs, Glasgow, KY - became Owens and MinorDirector Regulatory Affairs/Quality Assurance (highest level quality position)

Vangard Labs was a repackaging operation that bought bulk drug from pharmaceutical companies and repackaged them into unit dose blisters, bottles and pouches. This business manufactured one product line and packaged the product into pouches. This business handled cephalosporin packaging in separate facilities. Responsible for ANDA submissions and maintenance of 55 ANDAs; ANDA updates and labeling submissions; all FDA and DEA registrations. Responsible for all regulatory and quality operations including setting up a laboratory for stability and finished goods testing; and, final release of drug product to the market place. Position was the highest official for regulatory and quality for the organization. The Vangard Labs business was sold to Owens and Minor based in Richmond, VA.

ReferencesEd ThieleCatalent [email protected]

Anthony DeStefano, Ph.D.United States Pharmacopeia [email protected]

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mailto:[email protected]



Advisory Boards, 2013International Air Transportation Association (IATA), Time, Temperature & Transportation Board

International Quality & Productivity Center (IQPC) Pharma Supply Chain Distribution

Center for Professional Development (CfPA) Advisory Board, CGMP Training

Awards, 2013USP Annual Award: Innovative Response to Public Health Challenges. This award is presented to a

USP standards-setting body in recognition of efforts in addressing a special public health need or challenge. The General Chapters-Packaging Storage and Distribution Expert Committee was selected for its outstanding work and exemplary leadership in the development and revision of Compendial Standards related to packaging materials. In particular, the Awards Selection Committee noted the Expert Committee’s rapid response to the glass delamination issue through the development of General Chapter <1660> Evaluation of the Inner Surface Durability of Glass Containers. Also notable is the Expert Committee’s work on the upcoming suite of plastic packaging general chapters. The General Chapters–Packaging, Storage, and Distribution Expert Committee exemplified the volunteer spirit that defines USP’s commitment to address public health challenges.

Presentation & Training Examples2014 Jan Clinical Trial Conference Frankfurt, Germany

IQPC presentation: Supply Chain

Feb Pharma Conference Montreal, CanadaUSP General Chapter, Supply Chain,

April Pharm Tech WebinarSupply Chain Update: General Chapter Revision

Extractables & Leachables Workshop, USP

May Supplier Compliance & Counterfeiting ConferenceBest Practices to Ensure Supply Chain Integrity

USP Global Education & Training WebinarGood Distribution Practices: Proposed USP General Chapter <1083>

CGMP In-Depth Analysis for Pharmaceutical Life Cycle Management PresentationNew Brunswick, NJ

June Pharmapack NANYC, NYUSP GC <671> Container Closure Testing

July Novartis Animal Health CGMP Gap and Training Program

Sept CHPA Manufacturing & Packaging Conference & Supply Chain

CGMP Training Program 21CFR Part 210 & 211 Amsterdam

Oct IQPC Annual SC Conference Boston

Nov CGMP Training Seminar San Francisco

Dec CGMP Training Program North Carolina

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2013 Jan-JunJan Basel, Switzerland

IQPC presentation: USP Update on General Chapters on the drug supply Chain

Feb Phoenix, AZUSP Executive Committee, Council of Experts Mid-Cycle Meeting (5 year cycle)

Toronto, CanadaIQPC presentation: Pharmaceutical Supply Chain

May Panama City, PanamaWeb presentation on supply chain

Bethesda, MDUSP <671> Workshop: Moisture Vapor Transmission in Drug Packaging

Jun San Francisco, CABiologics presentation: supply chain

July - Animal Health Brand Firm CGMP Gap and Training Program

Nov Larchwood, IATraining Courses for entire plant

2012Jan Ottawa, Health Canada and USP, Chair

Revision to USP General Chapter <1079>

Basel, SwitzerlandIQPC presentation: Supply Chain

Feb Mumbai, India India Pharmacopeia with USP Biologics & Supply Chain dual conferencePresenter and moderator

Apr Bethesda, MDUSP Executive Committee, Council of Experts

Montreal, CanadaIATA Annual, Time & Temperature Committee

Jun Webinar on behalf of USP General Chapter <1083> and Expert Committee Work

San Francisco, CABiologics Clinical Supply Chain presentation

Jul NYC, NYCouncil on Foreign Relations, invited participant on pharma supply chain

Aug Berlin, GermanyIQPC Drug Product Integrity web presentation

Sept Sao Paulo, Brazil Sindusfarma Cleaning Validation 2-day session

Washington DC

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Homeland Security Standards Panel – presentation and panelist

Oct Berlin, GermanyPDA conference

PUBLICATION Recent Examples

2014

* CGMP Training Text * CGMP Refresher Booklet * CGMP Investigation Workbook

* USP General Chapter Revisions – Accountable for the following:<383> Elastomeric Closure for Injections (currently under revision)<659> Packaging and Storage Requirements (currently under revision)<670> Auxiliary Packaging Components<1083>Subchapters:<1083.1> Quality Management Systems<1083.2> Environmental Conditions Management<1083.3> Good Importation and Exportation Practices<1083.4> Supply Chain Integrity and Security<1083.5> Finished Drug Products (under creation)<1083.6> API’s (under creation)<1083.7> Excipients (under creation)<1083.8> Packaging (under creation)<1083.9> Clinical Trial Materials (under creation)<1178> Good Packaging Practices (under revision)

* USP General Chapters New<1661> Evaluation of the Inner Surface Durability of Glass Containers<1664.1> Sub-Chapter: Orally Inhaled and Nasal Drug Products

* USP Stimuli Articles - various

2013 * USP General Chapter revision: <660> Containers – Glass<661> Plastic Packaging <671> Containers - Performance Testing expert panel<1083> Good Distribution Practices<1118> Monitoring Devices – Time, Temperature and Humidity<1207> Sterile Product Packaging-Integrity Evaluation

* USP New General Chapter:* <1664> Good Manufacturing Practices – Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging Systems expert panel

* <1665> Good Manufacturing Practices – Assessment of Drug Product Extractables Associated with Pharmaceutical Packaging Systems expert panel

* Subchapters: <1207.1> Sterile Product – Test Methods<1207.2> Package Integrity Leak Test Technologies<1207.3> Packaging Seal Quality Test Methods

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mary sg foster cv jan2015

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