quality assurance - bibd.be · quality assurance in the life science, healthcare & cosmetics...
TRANSCRIPT
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Quality Assurance
in the life science, healthcare
& cosmetics industries
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Who is QbD?
• QbD Be founded in 2011
• QbD Nl founded in 2013
• QbD Es founded in 2016
• QbD Mexico founded in 2016 (partnership with BPF)
• Currently:
- 120 employees in Belgium & The Netherlands
- 40 clients, including Pfizer, Alcon, Biocartis, CAF/DCF, Zoetis, J&J, Genzyme, MSD, UCB, Heel, Multiplicom, Estee Lauder, Histogenex, etc.
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Product Life cycle
Development DistributionProductionDiscovery Sales & Marketing
• GMP (FDA/EMA/China)
• Production of API’s
(chemical and biological)
• Freeze drying
• Tableting, powders, aseptic filling
• Primary and secondary packaging
• Medical devices
• Product release & support
• Validation (equipment and processes)
• Automation (MES)
• Quality Management System (QMS)
• …
• GLP, GMP
• Laboratory methods
• Lab equipment
• Laboratory processes and
automation (CTMS and LIMS)
• Data management of
clinical data
• Up scaling of production
• Technology transfer
• …
• GDP
• Warehouse validation
• Tracing
• Serialization
• Logistics (lane validation)
• …
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Competences QbD
Quality
Assurance
• CSV
• Processes
• Lab and production
Equipment
• Methods
• …
• Development
• Commercial
production
• Operational Controls
• QA system
• Internal & External
Audits
• QP
• Training
• …
Technology
TransferValidation
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Technology Transfer
TT Framework
– standard processes
– templates
– road map
– …
Additional QbD support
– analytical method transfer
– raw material evaluation
– component qualification
TT Engineer
activities/responsibilities
– transfer documentation(Tech Transfer Master Plan,…)
– risk assessment
– process development-> master batch records
– overall co-creation of engineering/validation/stabilitybatches
– product validation protocol & report
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Professionals for pharma/biotech3 ways of doing business
Staffing
– project engineers
– qualification/validation experts
– auditors
– trainers
Academy model
– cooperation in the QbD Academy to co-source project engineering capacity
Projects
– technology transfer
– development and remediation projects: process (design, optimization, and validation), manufacturing (process, equipment and software validation)
– software implementations: ERP, MES, LIMS, CTMS, WMS, …
– outsourcing product release, auditing & training
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• Partnership between customer and QbD
• Win-Win
– for insourcing company: flexible capacity with hiring possibility
– offering possible long-term career after traineeship
– for QbD: trained & qualified people with practical experience, ready for projects after traineeship
– for the trainee: flexible career planning
• Areas
– software validation
– process and equipment validation
– method validation
– engineering
– QA
– regulatory
– …
QbD Academy Model
Graduate Trainee
Client contract
QbD consultant
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QbD Academy
Internal trainings
– GMP
– GDP
– GLP
– GAMP5
– Statistical processing
– Serialisatie
– Validation Basics
– Acceptance Sampling
– Design of Experiment (DoE)
– Quality by Design
– Intro in QMS system
– Tech Transfer
– Intro in Registratie
– Audit training
Skills
– Presentation
– Communication
– Interviewing techniques
– Time Management
– Communiceren met Impact
– Start to lead
Professional
– Business Process Modeling
– Project Management (Prince2)
– Lean Six Sigma
Knowledge exchange sessions
– QbD think tanks
– Competence centers
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Fun @ QbD
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Contact
BelgiumFotografielaan 18
2160 Wilrijk
The NetherlandsPivot Park
Molenweg 55
5349 AC Oss
SpainC/ Aragón 390-394
6ª Planta
08013 Barcelona
MexicoCuliacán 114A int. 202,
Del. Cuauhtémoc 06100
Ciudad de México
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ContactElly De Bruyn
+32 486 34 65 11
Hannah Dreesen
+32 499 32 30 37
Lodewijk Buffart
+31 651 31 11 09
Julie Bondroit
+32 495 78 00 11 Fotografielaan 18
[email protected] 2160 Wilrijk