USA PROJECT REFERENCES

Transcription

1 1 USA PROJECT REFERENCES

2 REMEDIATION-QUALITY CONTROL Support the analytical method validation for remediation efforts Context and Objectives: Team of (5) Senior and Junior QC Consultants performing method validation for remediation efforts Optimizing knowledge Management Measurement of the quality of service through KPIs Bench of QC Analytical Scientists (on Hand) Approach & Solution: Methods/SOPs triaged with respect to priorities and target timelines for completion Background information on relevant observations made by regulatory agencies and responses Expectations: Confirm which elements of validation are in scope, e.g., robustness testing Results & Added Value: Validation SOPs and associated CAPA s if any Method specific observations during both internal and external inspections and responses. Investigations, change controls and deviations involving each method and CAPA s Validation protocols Validation reports Method Transfer Reports Method Development Reports Reports on Purposeful Degradation Studies conducted and who to contact for samples if needed for validation. Samples of all excipients, starting materials, process related impurities, intermediates, degradants, excipients, etc. and contacts Specifications where methods are cited Contact for questions with respect to analytical method Access to statistician if needed for method robustness DOE s

3 OMS Oncology (USA/R&D/IS) Development to meet the rapid needs of the company s biomedical research division. Context & Objectives Life Sciences OMS Oncology development provides many of cross divisional agile web software development and reporting needs. Priding itself on a small, agile but highly adept technical team is one of the company s most sought after internal rapid development staff that can get a system designed, developed and deployed into production without any red tape, utilizing a Common Data Model approach and lightning fast software development architecture, tools, and technologies. Approach & Solution The OMS Oncology team is setup to be an internal rapid development resource response team at client site and to be a very agile and very effective group that works outside normal IT and thus doesn t have many of the same restrictions and encumbrances you would find in normal IT departments. The team currently consists of 9 resources (3 DBAs, 1 architect, 4 UI developers, 1 PM/QA). Each resource is capable of working in different roles and conducting different responsibilities from time to time. Results & Added Value The team has implemented and continues to develop a number of very visible and successful software projects for client site. These accomplishments include creating a Common Data Model for establishing future projects and developing projects such as BMD, OMS, ENC-OMS, VMS, and TTG to name a few. Other projects are underway including CRIKET and integrating financials. Also each member has to be flexible and resourceful and be able to work in different environments and work for the most part independently and effectively with some communication and very little specifications. Thus, new members must be adept, seasoned, flexible, and work outside the box to be successful. Functional Environment: R&D, Oncology Technical Environment: JavaScipt, ExtJS, AJAX, PL SQL, HTML, XML, JSON, CSS, Java Altran

4 Process Engineering Support development, execution of pilot runs, and tech transfer of processes. Context and Objectives: Support operationally 50 and 500P bioreactor, sweco, mixer, and centrifuge Execution of development and pilot runs for proprietary cell harvest process Provide data analysis and statistical analysis of pilot runs Approach & Solution: Generating development study summaries Drafting SOPs and batch records Results & Added Value: Daily support of operations in south side lab Proper documentation generated to support tech transfer, and process development Performing statistical analysis using industry standard techniques

5 RISK MANAGEMENT Assisting with systems engineering activities for products, including risk management and product requirements improvements, leading to safer products. Context and Objectives: Conduct product risk assessments for purposes of product remediation Implement new product requirements for purposes of product remediation Support efforts to react to product issues Approach & Solution: Leading risk assessment of current products Leading creation of component-level requirements for current products Supporting various regulatory inquires/responses and investigations Results & Added Value: Enables Hospira to update product files for FDA compliance Ensures timely responses to regulatory inquiries of products Allows easy future maintenance of new risk management files and requirements documents

6 ENGINEERING AND TECHNCAL WRITING SUPPORT Provide process engineering consultant services and general management support (VALIDATION) Review, revise, and generate Validation protocols and SOPs related to Consent Decree Validation and remediation. Develop robust training

7 RAPID (US, Sweden, UK/R&D/IS) Scalable and flexible software development service providing rapid response to business demand for IS support. Context & Objectives Life Sciences The Rapid service provides quick response to local needs for minor to medium-sized applications / tools. Each activity should require no more than 3 man-months of total effort to complete and focus on a prioritized business need that can be solved in that timeframe. The service should be sized to respond to all prioritized needs within 4 weeks (time from request to start of work). A key feature of the service is that the solution is developed in close collaboration and direct (onsite) interaction between the developer and the users, in a fast and responsive way. Approach & Solution The service is setup with local teams at each site, each consisting of three to eight resources. Each resource is able to take on the role as business analyst, developer and project manager. The teams are constituted of a mixture of consultants with a technical and scientific background, with everyone capable of producing efficient and qualitative software. The Altran Global Service Coordinator ensures that cross-site collaboration takes place where beneficial, that good solutions are reused and that ways of working are made both efficient and consolidated across the four sites. Results & Added Value Altran staffed the service to 100% from 1 st of May The staffing level starting from 2 FTE s in the early stages and reaching 21 FTE s by mid June 2012 across four R&D sites. The service has turned out to be even more effective than the client initially expected, maintaining a premium standard when it comes to skill-set and experience and interacting directly on local basis with the end-users with a much appreciated result. As the footprint of the service has been established, new clients other than the original has shown interest in starting using this flexible, scalable and rapid way of getting maximum value provided by IS solutions. Functional Environment: Regulatory Affairs, Preclinical,Clinical, PAR&D, Operations, GxP, 21 CFR Part 11, ECM Methodologies: Rational Unified Process Technical Environment: Documentum 3, 4, and 5, Oracle, FileNet, Visual Basic 6, Java, XML Altran

8 Quality Assurance Support Senior Consultant Supporting Deviation Management for Biotechnology Company Preforming critical assessment and suggest changes to deviation system, change control system and document control system Review process development reports Quality oversight for technology transfer

9 Upstream Technical Support Identify solution to process filtration issues Context and Objectives: After transfer, process experienced complete filter plugging during the harvest phase at full scale. Need to identify filter alternatives that will allow entire volume to be processed in the current equipment without product loss or exposing product to the environment to replace filters. Approach & Solution: Design pilot scale experiments to evaluate different depth filter media as well as downstream membrane media. Primary and secondary configurations identified that should provide the required capacity. Results & Added Value: Full scale runs to be performed in Q to confirm study results. Prevent product loss, reduce processing time, and prevent exposure of product to the environment.

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