Frank Mark Email & Phone Number

Professional ExperienceQuality Systems RemediationAssists clients with implementation and/or remediation of Quality Systems for development andmanufacturing operations, including assessing existing quality systems and assisting with their redesign and/or remediation.• Regulatory affairs and quality assurance management in conducting complianceremediation reviews.• Designs and implements compliance remediation plans based on compliance reviews.• Developing, amending and implementing quality system policies and procedures.Regulatory Compliance/ Domestic and International SubmissionsRemediation of GMP operations for development and manufacturing operations; performing assessments, audits, mock pre-approval inspections, and providing assistance in responding to FDA Form 483s, Warning Letters, and other regulatory notifications.• Review of DMF, ANDA, NDA, PMA, IND, IDE, CMC, and 510(k) documentation.• Submissions: CMC documentation, including manufacturing procedures, quality systems procedures, analytical methods and data, specifications, technical and validation documentation in support of regulatory submissions.• Writes procedures, implements GMP systems, trains personnel, and facilitates general problem resolution.• Annual Report: Performs drug product Annual Product Reviews.Auditing & Pre-Approval Inspection PreparationOversees the performance of quality system audits, gap analyses, and risk assessments for client FDA regulated manufacturing, laboratory and clinical supply manufacturing operations.• Mock PAI audits and risk assessments in preparation for Pre-Approval Inspections.• Assists clients with remediation efforts in preparation for FDA inspections• Provides technical and compliance support during and after FDA Pre-Approval Inspections.

Waltham, Ma, Us

Shawnee, Kansas, Us

Quality Systems Consultant• PAI Preparation: Trained personnel in GMPs, reviewed and approved critical quality assuranceprocedures; and directed the company’s first successful PAI.• Prepared responses to FDA Form 483 observations resulting in a successful closure of the inspection.Quality Systems Consultant• PAI Readiness Project: Performed gap analysis for manufacturing, packaging and QC operations.• Created comprehensive remediation plan based on gap analysis.• Revised the site document control and change control programs to conform to current FDAexpectations.• Coordinated implementation of the remediation program in support of the plan• Performed a comprehensive ANDA gap assessment for introduction of new products for the USmarket.Regulatory Consultant• Wrote site validation master plan for a new pharmaceutical R&D facility.• Assisted with the review and approval of new R&D facilities design and engineering documentation.• Assisted with the DMF submission for a critical excipient for a new sustained release product.• Conducted qualification audits of contract laboratories and raw material vendors.Quality Systems ConsultantReviewed and approved all laboratory procedures, material specifications, equipment qualifications,method validations, and development reports. Coordinated PAI preparation for the site, trained laboratory and R&D personnel on PAI activities, and assisted with the conduct of and follow up to the successful PAI.Quality System Consultant• Developed procedures for a new quality engineering department and assisted them withimplementation of those procedures.• Rewrote the site cleaning validation master plan.• Developed detailed cleaning validation rinse and swab sampling procedures.

Shawnee, Kansas, Us

cGMP Validation, LLC, Regional Director/Project Manager 1998-2002• Managed numerous validation projects at multiple pharmaceutical, aseptic and biotech facilities,including managing personnel in support of validation activities, client interactions, and remediationof significant quality issues associated with the construction and qualification of new/existingfacilities, including critical facilities, utilities equipment and processes.• Supervised and conducted quality reviews of operations related to the manufacture of finishedpharmaceuticals and clinical supplies.• Oversaw all validation activities associated with construction if several new pharmaceuticalmanufacturing facilities for various Rx NDA products.• Worked closely with in-house Cleaning Validation Department to review and revise cleaningvalidation procedures and to upgrade the Cleaning Validation Program. This included meeting withall levels of personnel within the department, reviewing cleaning validation procedures and cleaningvalidation program documentation, as well as issuing reports and making presentations to in-houseclient departments on the current status of the program.

• Re-Engineered all Quality Assurance functions focusing on product development, process andproduct technical transfer to manufacturing operations, and implementation of quality systemsthroughout research operations.• Directed all quality assurance activities and programs related to the research and development of new products from discovery through NDA filings.• Created comprehensive audit program of internal and external contract operations (GLP, GCP,GMP).• Established QA oversight for l drug development and manufacture of clinical supplies.

Ingelheim Am Rhein, Rhineland-Palatinate, De

• Aseptic Processing Facility: Restructured the QA and QC departments and enhanced quality control of all manufacturing and product development functions.• Remediation of microbiological and environmental monitoring program; restructuring and development of quality systems in support of document management and validation programs.• Successfully managed numerous Pre-Approval Inspections resulting in facilitated product approvals.• Served as the primary site liaison for the FDA resulting in several successful FDA inspections.

• Quality systems: Establish internal assessment/audit program for all manufacturing and qualitycontrol operations in support of blood fractionation, parenteral and solid oral dose drug operations.• Oversaw all activities in support of NDA and ANDA CMC filings, 510 (K) filings and BiologicalLicenses.• Restructured and upgraded the document control program for all master GMP documentationincluding batch records, packaging and labeling records, specifications, procedures, etc.• Served as the primary site host for FDA inspections which resulting in several successful FDA preapproval inspections.

• QA and QC controlled-release solid oral dose manufacturing; Preparation and filing of ANDAs;Primary company liaison with local FDA district office and FDA Office of Generic Drugs.

Silver Spring, Md, Us

• Conducted cGMP inspections of food, drug, and medical device manufacturing facilities throughout northern New Jersey (Newark District Office Area).• Accomplishments include numerous significant regulatory actions and removal of adulterated products from the market.• Performed as an acting compliance officer and Recall and Emergency Coordinator.