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Consultant Profiles
Understanding how regulatory changes affect your business requires time, knowledge and insight. Our experienced consultants will work with you and your team to identify compliance and process gaps, recommend best practices and solutions to resolve challenges, enabling you to optimize your workflow and mitigate risk through regulatory consulting, process optimisation, product and technology optimisation, staff education and training.
Find below a sample list of consultants profiles. Please contact us with your project requirements we will send you detailed profile of multiple consultant to choose from. |
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More than 19 years of direct and hands-on experience in the FDA-regulated industry, with emphasis and focus on Class I/II/III medical devices, In Vitro diagnostics, pharmaceuticals and biologics operations in the areas of regulatory affairs, compliance, validation, quality engineering and quality systems to ensure compliance with FDA and international regulations.
Expertise includes executing process validation, supplier qualification, training, internal/due diligence audits, policy/procedure development, PM, risk management/assessment, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, remediation, GxPs, SW Validation/IT Network, MDR/AE/product complaints, design/change control, CAPA, PMA, IDE, 510(k), NDA and e-CTD/CMCs submissions, interfacing with international regulatory bodies, QSIT and PAI Inspections, sample accountability and other related functions and tasks.
Experience -
- Domestic- extensive background in interfacing directly with FDA.
- International- Japan, EU, Canada regulatory bodies/agencies and also MDD 93/42/EEC and CE Mark and Notified Bodies.
Clients Served
Small, medium and large (start-ups as well as well established and mature firms).
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25 years of experience in the microbiology and sterilization practices of the healthcare industry. Provided the technical knowledge in support to product and process sterilization validation for large pharma companies.Over ten (10) years experience in the supervision and management of a laboratory and sterilization services group.
Expertise
EO and radiation sterilization are primary expertise as well as experience in other forms of sterilization. In addition, has experience in decontamination processes for contaminated devices and considerable knowledge of microbiological testing, environmental monitoring and the requirements for compliance to ISO and CEN.
Experience
- Conducted documentation reviews of procedures and validation files for medical device and pharmaceutical companies providing a summary of necessary improvements, rewriting procedures and completing final reports.
- Conducted sterilization, environmental and microbiology laboratory assessments for medical device/pharmaceutical companies with recommendations for GMP/GLP compliance and best practices.
- Conducted audits to determine conformance with United States Quality System Regulations, ISO 9000 and EN 46000 of contract sterilization and laboratory facilities.
- Developed cleaning validation plans, quality manual to be in compliance with current Quality System Regulations.
- Assisted companies in responding to the FDA following/during inspections.
Clients Served
Medium and large companies as an employee and as a consultant.
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28 years of past industry experience as R & D Director and Global Director of Regulatory Affairs for gloabl chemical companies. Areas of expertise include Strategy Development, Regulatory Compliance Pharmaceuticals / Biologics, Regulatory Compliance Medical Devices / Combination Products, Technical Writing: Trial Protocols, Marketing Authorizations, Manufacturing Authorizations, Inspections / Audits.
Expertise
Authorized Rep. / Legal Rep. in EU, Strategy Development, Clinical Trial Set-Up, Marketing Authorizations, License Renewals, Variations / Amendment Filings, Manufacturing Authorizations, Drug Master Files, Certified Medical Writing, CRO Management & Selection, Inspection Assistance / Pre-Audits.
Experience
International Regulatory Surveillance Updating: NA, EU, Japan, LAA worked for clients to Represent of company & products to specific agencies, governments, commissions. Getting ISO compliance & certification.
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30 years with a practical, hands-on approach on Regulatory filings, including NDA, ANDA, 510K, PMA, BLA, Recall processing and defense, Compliance defense, Enforcement advice and defense Inspection / Audit preparation and response, FDA negotiations on behalf of clients.
Expertise
Software testing, software validation, software quality, audit preparation, response to FDA-483s, warning letter prevention and response, consent decree remediation.
Clients Served
Small, Medium and large organizations.
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33 years of progressive positions from Investigator, Supervisory Investigator, Investigations Director and then to Assistant Regional Director for the Pacific Region.
Expertise
Analytical Laboratories, Animal test facilities, Audits (including unannounced), Combination products (Drug/Device), Contract operations, Drug development advisories, Due diligence GCPs, CGMPs & GLPs, Evaluations, FDA inspections, Foreign APIs, Import procedures, New Drug Development, NIH submissions (research, NDA), Regulatory affairs, Research laboratories.
Experience
- Independent Resident Post work focusing on broader scope of industry including drugs, as well as foods and other commodities.
- Supervision of group of Investigators heavily involved in drug work, devices and many other commodities.
- Oversaw QC/QA to assure proper strategy and evidence development.
- Branch Director over 6 Supervisors and staff of 70 to 80 personnel including 8 Resident Posts in California, Hawaii and Nevada.
- Domestic and import activities covered all commodities and operations from work-planning through case development coordination with Laboratory and Compliance Branches and other agencies.
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Ten years of project management experience, Four years of design review experience, Four years of validation, documentation, training experience, Experienced with CFR21 Part 11, GAMP 5 requirements in GMP environments.
Expertise
GMP Environment, Project Engineering, Documentation.
Experience
- Reviewed the facility's design basis, with respect to the process, CIP and SIP piping systems from the perspective of capital cost and operating efficiency.
- Review and evaluation of the validation strategies and practices for a newly constructed biopharmaceutical pilot scale manufacturing facility and its process and clean utility systems.
- Provided control systems and automation development project management using GAMP5 and 21 CFR Part 11 requirements at the Andover manufacturing facility.
- Responsibilities included overseeing compliance to norms for design of skids, Process Sequencing, Phase table design, System startup including and HMI testing and verification, supporting IQ/OQ/PQ, P&ID reviews and other commissioning activities. Also responsible for training client.
Clients Served
Small, Medium and large organizations.
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13 years industry experience in the pharmaceutical and biotech industry in the areas of regulatory and investigative toxicology with broad, leading edge experience in the development of drugs: from target validation to clinical development.
Expertise
Immunology, Inflammation, oncology (multiple targets), Diabetes, CNS, Anti-infective and signal transduction pathway modifiers.
Experience
Pharmaceutical and biotech industry in the areas of regulatory and investigative toxicology.
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Affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA/Quality Systems, Regulatory Affairs/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers.
Expertise
Process validation, supplier qualification, training, internal/due diligence audits, policy/procedure development, PM, risk management/assessment, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, remediation, GxPs, SW Validation/IT Network, MDR/AE/product complaints, design/change control, CAPA, PMA, IDE, 510(k), NDA and e-CTD/CMCs submissions, interfacing with international regulatory bodies, QSIT and PAI Inspections, product registration, J-STED/Ninsho activities.
Experience
- Executed effective paths to obtaining approvals, worked effectively across functions for overall corporate compliance and aligned GxP compliance in a fashion that supports a company's business strategies and goals.
- He has worked on and currently working on several J-STED files and Ninsho Certification, IDEs, PMAs and 510(k) submissions and applications, as well as serving on teams related to clinical trials development and deploying sustainable and proven strategies.
- Currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology.
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20 years of hands-on and executive experience in biopharmaceutical and pharmaceutical process development and quality, over 45 publications and 4 process patents.
Expertise
Process development, CMC and quality systems, QA audits, GMP training, QC laboratories and IND/BLA support, clinical trials production, process validation.
Experience
- Has provided GMP training for numerous firms as well as the University of Wisconsin and gives frequent audio seminars.
- She held technical and quality control/assurance positions of increasing responsibility before founding Shadle Consulting in 2001.
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If you liked a profile and want to know more about him/her, please contact us with project requirements.
Email - consulting@complianceonline.com
Call +1-650-620-3918 |
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