An introduction to
Volt Pharma Associates
Quality Management &
Regulatory Compliance (QMRC)
Services
“From Uncertainty to Confidence through Compliance.
Define, drive and deliver your products successfully throughout their
lifecycle.”
Volt Pharma Associates
www.vpa.eu.com
Volt Pharma Associates (VPA) – Overview
OUR ETHOS
We are “committed to delivery through collaboration”: Volt Pharma Associates is dedicated to consistent
delivery of successful client outcomes through collaboration, quality assurance, flexibility, cultural alignment,
transparency and knowledge sharing.
WHO WE ARE
We are a group of world-class BioPharmaceutical subject matter professionals, who put best practice to work
for our clients, designing integrated innovative solutions - on both product and organizational levels - for the
complexities of a constantly changing life sciences ecosystem & marketplace. The calibre of people we allocate
to our clients’ projects, people with 20 and 30 years of hands-on experience in their subject matter, combined
to a project team covering multiple subject matters depending on our client’s specific issues and situation
complexity, is truly unique in the industry. Our unbiased approach enables our clients to realize their business
goals by minimizing risk, raising product / portfolio value, saving cost and reducing time to patient.
VPA is part of Volt Information Sciences, Inc., a global provider of talent, technology and consulting services.
Volt is a highly successful, 6 Sigma company with offices in North and South America, Asia and Europe.
WHAT WE DO – OUR SERVICES
With our unique fusion of expertise in the full range of disciplines across the product lifecycle, we help
releasing the full potential of our client’s products and organisations.
We provide strategic decision making, planning, and management as well as optimised resourcing to execute
strategic programmes and projects. We operate as a lean structure without organisational overhead and pass
on the benefits created directly to our clients with payment linked to successful outcomes achieved against
time, quality and cost based deliverables.
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Volt Pharma Associates
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Quality Management & Regulatory Compliance (QMRC) Services
SERVICES
No pharmaceutical / biopharmaceutical / medical device company can afford an expense such as non-compliances,
consequences may involve having a product withdrawn from the market or having a high-profile approval delayed.
Setbacks associated with routine agency inspections, as well as more serious Warning Letters are costly and often
result in approval delays, product recalls, harm to reputation, and adverse impact on shareholder value. VPA’s
experts can help with:
Auditing:
 GMP, GLP, GCP, Pharmacovigilance, Device Vigilance, Quality Systems, Management Controls, FDA / EMA /
national agency -type Mock PAIs and Inspections, Verification Audits and Effectiveness Checks, Gap Analyses
& Remediation, Vendor Audits, For-Cause Audits, (e)TMF Audit, PV DB Audit, Failure Mode & Effects Analysis
(FMEA), Risk Analysis
Regulatory Compliance:
 483/Warning Letter responses, IAG coordination and other correspondence, Consent Decree remediation
activities, preparation for or attendance at FDA meetings, Serious Breach of GCP
Training:
 General & refresher GMP, GCP, GLP topics, EMA, FDA, national agency interaction and preparing for
inspections, 1:1 mock interviews, auditing techniques, specific technical training
Inspection Management Process and Planning:
 Review hosting process and site presentations, tour routes, front/back room management, document
management, employee coaching
Technical Writing:
 Validation Protocols and Reports, SOPs, Annual Product Quality Reviews, agency correspondence, audit
responses, strategic plans, trend analysis reports, other technical reports, validation plans,
Data Trend Analysis:
 Collection, review, analysis and summary reporting for Deviations, OOS, Change Controls, CAPA, Complaints,
Product Returns, root cause analysis
Project Management:
 For complex or long-duration Consent Decree or compliance remediation activities, multi- site/consultant
audits, validation reviews
 Project Management of pre-clinical drug development through to manufacturing and supply of Phase 1 and
2 Clinical Trials drug product in multi-site operations, project management of device development
 Programme / Project Management of Capital Projects from building clean room facilities, Design for
manufacturing assembly (DFMA), New Product Introduction (NPI), managing principal consultants and
subcontractor teams, documentation such as User Requirement Specification, supplier evaluation,
equipment procurement, validation, process validation.
 Operation Quality Management, managing teams, delivering required outputs, managing operational
budgets, developing operations teams, continuous improvement plans, succession planning, development
programmes for fast track staff.
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Volt Pharma Associates
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TEAM BIOGRAPHIES
John Seagrief, BSc, MBA
John has extensive experience in the pharmaceutical industry gained over his years in the
industry. This ranges from project management of new facility construction, facility, equipment
and process validation, and staff training to operating manufacturing facilities and delivering
quality compliance systems. He has managed steriles product development and formulation,
manufacturing / business development, and spoken at conferences. He works in interim
management, Quality Systems support, Good Manufacturing Practice (GMP) consulting, and
compliance.
His specialties include: GMP, Parenterals, Aseptic Manufacture, Terminal Sterilisation, Lyophilisation, Formulation
Project Management, Business Development, conference speaker, Quality Systems, Interim Management and
Consultancy, Training.
Sean Charley, BSc (Hons) MIET
Sean brings 30 years of engineering expertise to the team with a hands-on approach to
solutions management. He has start-up and high volume experience within the Pharmaceutical
and Medical Device industries, establishing manufacturing systems, optimising processes and
product design to enable clinical trial through to volume scale-up.
A broad breadth of experience brings with it a vision to pre-empt what can become expensive
and complex issues down-stream. ”Focussing on Design, Materials and Manufacturing
Equipment is central to establishing the foundations for a successful product”.
His specialities include: Projects, Process, Validation solutions (Medical device, Pharmaceuticals, Manufacturing),
Project management, Equipment specification & procurement, Process optimisation (Start-up, High volume),
Validation - equipment & process (VMP, DQ, URS, HDS, FDS, FAT, SAT,IQ, OQ, PQ, VSR), Regulatory - 21CFR820,
ISO13485, Risk management / assessment (pFMEA, HAZOP), IVDD - design & process optimisation, New Product
Introduction (NPI), Design for Manufacture & Assembly (DFMA), Clean room installation & validation, IV bag
specification, packaging & sterilisation, Asset Maintenance Management (OEE, PPM, TPM, Lean), Assembly,
packaging & test solutions, Services & facilities installation management.
Marcus Benton, MSc Quality, MBA
Marcus is an MBA-qualified quality assurance professional with extensive knowledge and 29 years
of good laboratory practice / good clinical practice expertise in quality management systems in the
research, manufacturing and pharmacovigilance sectors of the pharmaceutical industry in Europe,
Asia and the US.
He has worked for contract research organisations and pharmaceutical companies, and is often
able to see issues, and hence create solutions, from many angles. He is a Fellow of The Research
Quality Association and has implemented 7 Quality Management Systems and audited many
more. He has hosted more than 12 Department of Health inspections. He is regularly invited to present at
international conferences, round tables, UK and French university postgraduate courses on good laboratory
practice/good clinical practice, validation of computer systems, quality assurance tools and risk-based-quality
where his laconic style is much appreciated. He has hands-on laboratory experience in developing methods for
cryopreserving cells and tissues in the US and the UK.
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Volt Pharma Associates
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Amrit K. Judd, PhD, MBA
Amrit is a Senior-Level Pharmaceutical Consultant with more than 20 years of experience,
combining quality, regulatory compliance, and pharmaceutical R&D expertise to prove an asset
to pharmaceutical and biotechnology companies throughout the U.S., Puerto Rico, and Europe.
Extensive QC/QA experience and knowledge in analyzing drugs for Safety, Identity, Strength,
Purity, and Quality (SISPQ).
Her specialties include: Chemistry, Manufacturing, and Control (CMC), FDA GXP Compliance and
Regulatory Affairs (cGMP, GLP, GDP), 21 CFR Food, Drugs, Cosmetics; APIs, Medical Devices, and Drug/Device
Combination Products. Good Laboratory Practice for Nonclinical Laboratory Studies, and ISO13485
Compliance. Batch Record Review for manufacturing, GMP Compliance & Regulatory Affairs, Quality
Compliance & Assurance, Deviations & Investigations Management under 483 and Consent Decree
environment, SOP Documentation, CD Verification & Warnings, and Drug Certification, Pharmaceutical
Research and Development.
Review BLA supplement, compose assessment report for FDA for regulatory strategy/pathway and conduct
regulatory path. Coordinate and review Design Control document, Device Manufacturing File (DMF), Device
History File (DHF), and Risk Management document. Monitor and review batch records for drug and API
manufacturing, reporting observations and recommendations, review process and equipment validation, and
recommend CAPA. Conduct GAP Assessment.
Bob Jones, BEng
A chemical engineer with over 14 years’ experience in the pharmaceutical and medical
devices industry with extensive experience in C&Q (commissioning and qualification) and V&V
(verification and validation) of pharmaceutical facilities, equipment and utilities to industry,
MHRA and FDA standards. This ranges from project management and equipment selection to
commissioning of production facilities, production equipment and clean/non clean utilities
and the generation, implementation and execution of validation documentation and
validation protocols from pre to post approval using relevant guidance.
He is well practiced in interpreting technical data and information to facilitate decision-making and
experienced with established project management and planning tools to ensure agreed timelines, budget and
quality targets are met. In-depth working knowledge of cGMP, GAMP, ISPE Baseline Guides, EN285, ISO14644,
etc and an excellent understanding of pharmaceutical and medical devices regulatory requirements.
Specialties: Steam in Place (SIP) & Clean in Place (CIP) validation and cycle development, sterilisation
processes qualification & cycle development (Autoclaves, Depyrogenation, VHP), Lyophilisation cycle
development & qualification, Commissioning and validation of process equipment, facilities &utilities,
validation process documentation (VMP, VP, DQ, URS, FDS, FAT, SAT, IQ, OQ, PQ, VSR and template
generation),Clean room qualification (Particle counting, Air flows, Integrity Testing, Smoke Studies etc), thermal
mapping studies, Deviation Resolution, Technical Investigation & Reporting, Preparation and presentation of
validation documentation to MHRA and FDA inspectors.
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Volt Pharma Associates
www.vpa.eu.com
CASE STUDIES
Case study 1:
 Situation: Pharmaceutical operations remediation to restore licence to manufacture from the regulatory
inspectors
 Service: Interim operations management
 Result: The remediation team working to deliver operations and engineering systems remediation from
an operations perspective as part of a Quality Management programme to pass an inspection to regain a
manufacturing licence.
Case study 2:
 Situation: A pharmaceutical company looking to move to disposable systems and change the primary
packaging
 Service: Project management of feasibility studies
 Result: The feasibility studies collated operational information, timelines, impacts and costs which
allowed the management to decide on the acceptability of the projects.
Case study 3:
 Situation: Newly established Medical Device start-up company, developing a disposable in-line, arterial
blood gas analyser (IVD).
 Service: Improved product design to the moulded device with manufacturing, assembly, cost and
materials in-mind. Procured and established a manufacturing suite complete with cleanroom to enable
low to medium volume product for use in Clinical trials.
Project managed external supplier/contractors - Moulding manufacturer, Electronics assembly
manufacturer, Final assembly / test & packaging, IV Bag development and supply.
 Result: Successfully manufactured patient compliant product for use in Clinical trials tests, phase I & II.
Successful FDA 510(k) submission for premarket approval.
Case study 4:
 Situation: Established global healthcare and consumer electronics company, manufacturing systems
regulatory compliance review.
 Service: Quality systems & Validation Consultant reporting to the Manufacturing Director, we were able
to establish a “validated state” assessment report in readiness for an anticipated FDA audit. The report
impacted all manufacturing sites within the business.
 Result: On completion of a full retrospective validation review, departments were able to identify specific
areas for improvement and put the necessary tools in place to target specific areas for improvement,
resulting in a successful external audit by third party auditors the following year.
Case Study 5:
 Situation: Vendor Audit for US FDA and EU/EMA compliance.
 Service: Prepared & conducted a vendor audit and submitted the Assessment Report to Qualify a Second
Source of Device. Preparing an audit checklist for FDA and EU/EMA regulatory compliance. Reviewed BLA
documents.
 Result: The strategy that was recommended to client was to obtain approval of a second source of the
device is to prepare a comparability protocol and submit to FDA and EMA for review and approval. Once
the comparability protocol is approved, client will initiate the testing and submit the package as a
supplement/variation to its current BLA/MA for final approval to commercializing the new source of
device.
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Volt Pharma Associates
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Case Study 6:
 Situation: Review of Drug Manufacturing Batch Records for GMP and Regulatory Affairs compliance
under Consent Decree environment.
 Service: Reported observations concerning Deviation, Process Validation, and GMP and Regulatory Affairs
compliance.
 Result: Recommended Deviation Investigation Management and Corrective Action, Preventive Action, in
some cases, in order to improve manufacturing process with respect to GMP and Regulatory Affairs
compliance.
HOW DO VOLT PHARMA ASSOCIATES ADD VALUE?
Solutions tailored to your needs:
 Best-in-class knowledge, skills and experience to guide projects, programmes and portfolios to
deliver their full value.
 Hands-on strategic consultancy services, loaned executives, or complete project teams.
 When you need it, for as long as you need it.
 Accountability: Payment linked to successful outcomes achieved against time, quality and cost based
deliverables.
 Flexible commercial options including fixed price contracts
You benefit from expert business interventions that support at multiple levels:
 Strategic planning & decision making
 Management and execution of key business activities including drug development programmes,
outsourcing, technology choices and investments.
 Cost optimisation programmes and strategic workforce optimisation.
 Optimised resourcing of demand including strategic demand management and planning at portfolio
level through to tactical resource optimisation.
Sharing “lessons learned” from across life sciences and other industries to drive innovation that delivers
competitive advantage.


New development models drawing elements from open/collaborative innovation enterprises.
Enhancing risk management practices by learning from mature industries.
HOW DO WE WORK WITH YOU?
We work as your trusted colleagues, accountable, aligned, committing quality and performance excellence,
from advice on specific issues to full outsourcing:
Advice:


Consulting advice on issues requiring rapid response
Guidance on difficult to solve problems
Partial Outsourcing
 Lead components of major projects
 Individual experts dedicated for extended periods
Full Outsourcing
 Fully loaned executives
 Turn-key projects with dedicated teams
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Volt Pharma Associates
www.vpa.eu.com
HOW WILL WE OPERATE ON YOUR PROJECT?
We create tailored solutions and seamless integration to fit your product, your organisations’ needs and
your goals. These are not quick fixes but any changes are aimed to be embedded – it’s a solution that lasts
and not a quick sticking plaster.
Close Client Collaboration & Project Management
Understand
the
Problem
• Set clear scope and
objectives
• Build rapport and
strong working
relationships based on
trust
• Develop clear
understanding of the
problem
• Define an effective
project structure and
ways of working together
Define the
Solution
• Define tailored,
pragmatic solutions
• Socialise and gain
endorsement to
implement
• Plan the
implementation
• Define change
management
approach
• Agree measure of
success
Deliver &
Embed
• Implement the
solution
• Define the
mechanisms and
approaches to embed
the change 'Make it
stick'
• Implement metrics
• Learn the lessons
Maintain
the Value
• Monitor measures of
success and metrics
• Ensure that changes
continue to deliver
value
• Review and refine
• Set new baseline
performance
CONTACT FOR FURTHER INFORMATION
Managing Partner: Claude Houet
Title: Head of Practice - Pharmaceutical and Life Sciences Industry
Telephone: +49 (0) 172 6340202 (mobile); +49 (0)761 600 69 355 (office)
Email: [email protected]
Website: www.vpa.eu.com
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