- Date:
-
- Webinar
GMPs for Equipment, Utilities and Facilities - Live Online Training
- Event location:
- online
- Organizer:
- CONCEPT HEIDELBERG GmbH
QA systems with technical relevance
Part 1:
Change Control, Technical Changes and Marketing Authorizations
Part 1:
Change Control, Technical Changes and Marketing Authorizations
- Regulatory Requirements
- Identification of “Changes” - What has to be handled under Change Control?
- CC-Workflow and pitfalls
- Change Management in Routine Operations vs. Project work
- Marketing Authorization - Regulatory Affairs for Engineers
Part 2:
Deviations, CAPA & Malfunctions
- Deviations in the technical Environment
- Documentation in logbook and higher-level Systems
- Evaluation of technical deviations
- When does a deviation require CAPAs?
- Handling of Alarms
- Correlation between changes, deviations, repairs and maintenance
- Examples
Risk Analysis
- Managing risks in the technical Environment
- Project risks
- Equipment risks
- Product risks
- Risk management Tools
- Examples
Integrated Commissioning & Qualification
- Old V-model and new approaches
- Project Steps & GMP regulations
- Quality Overview & Control for Project Work
- GEP, SME, CQA & CPP: Keys for Commissioning & Qualification - Process
- What to include in an URS - & what not
- PID, Layout, Component-list, FDS, SDS, HDS, Material Certificates
- Re-construction vs. Green Field Projects
GMP Zone Concepts (sterile/non-sterile/highly potent)
- Basic GMP requirements for materials & pharmaceuticals handling
- Physical requirements (areas) vs Dynamic requirements (HVAC)
- Finding the correct requirements depending on the manufacturing Operation
- Defining an appropriate layout and air lock concept
- Defining personnel & material flows
- Product vs Personnel Protection
- Product Protection concepts, types of air flows
- Avoiding Cross Contamination: the EMA idea
- The future of barrier systems (Isolator and RABS)
GMP Class Requirements (HVAC and Barrier Systems)
- Some HVAC system concepts (e.g. fresh air / recirculated air)
- Understanding the main parameters (volumes, pressure, cleanliness, etc.)
- GMP Classification and ISO standards, and their interaction
- The basics of air filtration and flushing air circulation
- Particle testing depending on the cleanroom Zone
- Microbiological monitoring in a cleanroom
- Requirements on construction of floors, ceilings and walls
- Classification, Qualification, Requalification of Cleanrooms
What does GMP-compliant Design mean?
- GMP-Design & -Risk: It depends on the product…
- Special cases / Parts / Procedures: Heat Exchanger, Sampling Valves, Power Supply Safety, Clean-Room-Screw, Thread lubrication
- Cleanability, Turbulent Flow & Surfaces / Biofilm
- Drawings: PID-Symbols & 3D-rule
- Pest Control during construction & maintenance
- Documentation GEP vs. “ALCOA-plus”
- IT-life-cycle for GMP-Equipment
Basic Aspects of Hygienic Design and Material Selection
- Risk-based approach for the selection of suitable materials
- Equipment-specific definition of the hygiene-critical area
- Open & closed Equipment
- Construction aspects
- Cleanability
- Drainability
- Pipe Connections
- Screw Joints
- Inner corners and angles
Process Contact Surfaces: Specifications and Surface Treatments
- Definitions of surface qualities
- Surface quality requirements
- Surface treatment Methods
- Mechanical Treatment
- Chemical Methods
- Electrochemical treatment
Pipework and Fittings, Connections, Welding & Seam Control
- Piping & Tubing Standards
- Cleanability & Dead Legs
- Detachable Connections
- Welding Technology & Welding Quality Criteria
Requirements for the Process Environment: the Clean Room
- Clean Room standards and classes
- Selection and procurement - factors influencing the selection of components
- Wall and ceiling Systems
- Acceptance tests for wall and ceiling
- Requirements for clean room doors
- Floor Systems
- Acceptance tests for Floors
- Critical clean room interfaces
- Application of components for different cleanliness classes
Upgrading, Re-Construction and Renovation of Facilities
- Required as built documentation to start
- What to consider in re-construction projects?
- Upgrade of an HVAC System
- How to protect the ongoing manufacturing operations
- Protection of products
- Protection of equipment, rooms and HVAC
- Flow concepts and control of external personnel
- Access control, pest control, cleaning
- Documentation of protective measures
- Examples from recent projects
GMP Utility Systems (Water / Steam / Gases)
- Generation: From Source Review to Purified Water, WFI, Pure Steam
- Components: working principles (Softener, EDI, RO, UF...)
- Storage and Distribution concepts
- Sanitisation principles
- Automation, Instrumentation, Trending
- Specification & Design for Compressed Air
- Safety for Nitrogen-Systems
- API contaminated waste water
Maintenance & Calibration
- Life-cycle model of pharmaceutical Equipment
- How to set up and maintain a maintenance/calibration System
- Definition and control: frequencies, activities, tolerances, acceptance criteria, etc.
- Timing of activities
- Documentation & labeling
- Data integrity
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Germany
Phone: +49 6221 844415
Fax: +49 6221 844464
email: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
