Volt Pharma Associates (VPA) Quality Management & Regulatory Compliance (QMRC) Services

Transcription

1 Product An introduction to Volt Pharma Associates (VPA) Quality Management & Regulatory Compliance (QMRC) Services From Uncertainty to Confidence through Compliance. Define, drive and deliver your products successfully throughout their lifecycle.

2 Volt Pharma Associates Volt Pharma Associates (VPA) supports life sciences companies, investors, not for profit and academic institutes in developing new products, technologies and innovative approaches. VPA s aim is to solve its clients product research, development and commercialisation challenges so they can achieve their business goals. VPA does this using a team of over 100 world-class life sciences industry experts with hands-on experience and proven track records. VPA is part of Volt Information Sciences, Inc., a global provider of talent, technology and consulting services with offices across North & South America, Asia and Europe. Volt is a highly successful, Six Sigma company generating annual revenues in excess of $2 billion. WHAT MAKES US SO UNIQUE Unrivalled Integrated Unbiased Expertise in All Areas of Pharmaceutical Activity, Strategic Decision Making and Project Execution, Immediate Access, Low Overhead Costs and Competitive Rates. All aiming to Maximizing the Value of your Products and Reducing Time to Market. We offer an unrivalled wealth of integrated expertise in a full range of disciplines involved in life sciences research, development, commercialisation and regulatory compliance. We provide strategic decision making, planning, and management as well as optimised resourcing to execute strategic programmes and projects. We dispose of a large international network of world class biopharmaceutical & medical device industry specialists to which our clients can have immediate access. Our unbiased approach enables clients to realize their business goals by maximizing product value and reducing time to market. 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. KEY SERVICE AREAS With expertise in the full range of disciplines across pharmaceutical activity, VPA is ideally placed to provide support across Research, Development and Commercialisation of new products, technology and innovative approaches. Discovery Preclinical Early Clinical Late Clinical Market Analytical chemistry * Clinical development * Clinical pharmacology * Commercial assessment and valuation of biopharmaceutical assets * Financial analysis and deal terms for licensing and acquisition * Health Technology Assessment * Intellectual property * Manufacture and formulation of investigational medicinal product * Medical/regulatory writing * Medicinal chemistry * Operational effectiveness and organisational assessment * Pharmacokinetics and drug metabolism * Pharmacovigilance * Pricing, reimbursement and market access * Project management * Project product and portfolio decision modelling * Quality assurance and strategic compliance (GxP) * Regulatory strategy * Statistics and data analytics * Therapeutic area and competitor intelligence * Toxicology 2013 Volt. All rights reserved. Proprietary and confidential. 1

3 SUPPORTING PRACTICES VPA s Key Service Areas are supported by a number of dedicated practices. These are the centres of innovation at VPA and consist of experts with many years of practical experience in their chosen fields. By combining our unique wealth of expertise we aim to deliver the full value of our clients products. P3M VPAC LSS P3M: Portfolio, Programme and Project Management VPAC: Commercialisation services CRCS Product Value Pharm Sci POEM: Project Opportunity Evaluation & Maximization, CRCS: Clinical & Regulatory Pharm Sci: Pharmaceutical Sciences POEM RCQM QMRC: Quality Management & Regulatory Compliance L&D: Learning & Development L&D LSS: Lean Six Sigma VOLT PHARMA ASSOCIATES ETHOS Committed to delivery through collaboration VPA is dedicated to the consistent delivery of successful client outcomes through collaboration, quality assurance, flexibility, cultural alignment, transparency and knowledge sharing. VPA is committed to adding value and operates with a lean structure, passing on the cost benefits created directly to clients. All of VPA s colleagues assigned to your project have access to, and are supported by, a strong team of highly experienced pharmaceutical professionals to ensure that they consistently deliver the quality of service required Volt. All rights reserved. Proprietary and confidential. 2

4 Regulatory Compliance and Quality Management practice : 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: Training: 483/Warning Letter responses, IAG coordination and other correspondence, Consent Decree remediation activities, preparation for or attendance at FDA meetings, Serious Breach of GCP 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 2013 Volt. All rights reserved. Proprietary and confidential. 3

5 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. Core Team Bios 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 Volt. All rights reserved. Proprietary and confidential. 4

6 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. 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 Volt. All rights reserved. Proprietary and confidential. 5

7 Rob Bones, 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 Volt. All rights reserved. Proprietary and confidential. 6

8 Case studies The following examples illustrate the experience and value that the VPA QMRC team can bring to clients: Case study 1: Situation: Pharmaceutical operations remediation to restore licence to manufacture from the regulatory inspectors Service: Interim operations management Result: Part of 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 Volt. All rights reserved. Proprietary and confidential. 7

9 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. 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 Volt. All rights reserved. Proprietary and confidential. 8

10 How does 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. Support whenever you need it, for as long as required. Flexible commercial options including fixed price contracts with payment linked to successful outcomes achieved against time, quality and cost based deliverables. You benefit from expert business interventions that support at multiple levels: Strategic planning & decision making Management and execution of key business activities including compliance programmes, 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 Volt. All rights reserved. Proprietary and confidential. 9

11 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 We create tailored solutions and seamless integration to fit your product, your 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 Volt. All rights reserved. Proprietary and confidential. 10

12 Contact for further information VPA RCQM Lead John Seagrief Volt Managing Partner: Claude Houet Telephone: +49 (0) VPA website: Volt. All rights reserved. Proprietary and confidential. 11