Solution
A major challenge for many companies in the Life Science Industry is defining their requirement. At PharmaBioSolutions our consultants have several years of experience in working with pharmaceutical and Biotech plants. They will assist you in defining, analysing and capturing your requirements. Based on their extensive experience they will be asking appropriate questions to examine various aspects of your requirements to minimise the risk during the im’plementation and increase “speed to market”
• Assistance in defining and analysing your production requirement
• Assistance in writing User Requirement Specification
• Assistance in Risk Assessment
• Review of design documents
• Project management services
Equipment and Machinery consultancy services
Selection of equipment and machinery is another major challenge for the companies. Our consultant will assist in defining your requirement and will take the lead in identifying and qualifying suitable vendors. They will subsequently assist you in bid review and vendor selection.
• Defining requirement for the equipment and machinery
• Identification and qualification of suppliers
• Vendor Audits
• Assistance in bid review and selection of suitable supplier
• Review design documentations (DQ) supplied by the selected vendor
• Assistance during Factory and Site Acceptance test
• Assistance for IQ, OQ and PQ
• Assistance in writing Standard Operating Procedures
• Validation Summary Report
Training is a key requirement for all regulatory bodies around the world. PharmaBioSolutions consultants have been providing training for large number of Pharmaceutical companies around the world.
Training course are tailored to the needs of individual pharmaceutical company and can be targeted at different group. Attendees of training courses will be issued with a formal training certificate.
All training courses are designed to be interactive and will require attendee participation. Training course will include presentation of topics followed by workshops. For the workshops attendees will be divided to teams and are given tasks related to topic covered. This method of training has proven extremely effective and will help the attendees to better understand the training topics covered.
PharamaBioSolutions consultant will prepare the course material which will be handed to attendees at the beginning of the training course.
Training courses will be generally held at the client’s nominated location. This will help to reduce the travelling cost for the attendees and allowing larger number of attendees.
Training courses will be delivered in both English and Chinese and training material will be also in both English and Chinese.
Training courses are designed to be highly modular. This will help the clients to select the modules appropriate for their engineers and experience.
GAMP5 Training
Introduction to GAMP5 covers GAMP5 history, key concepts and categories
Introduction to URS followed by workshop
Introduction to Risk Assessment followed by workshop
Introduction to Quality Plan followed by workshop
Introduction to FDS followed by workshop
Introduction to HDS followed by workshop
Introduction to SDS (Software Design Specification) and SMS (Software Module Specification ),
Introduction to Configuration Management & Configuration Schedule
Introduction to Testing followed by FAT and SAT workshops
Introduction to Final Quality Reporting followed by workshop
Ongoing operation
Electronics Records and Electronics Signatures (ERES) Training
Introduction to ERES covers history, key concepts, scope
Instroduction to FDA 21 CFR PART 11
Instroduction to EMA GMP Annex 11
Testing
Summary and discussion
ISA S88 Training
Introduction to S88
Process model followed by workshop
Physical model followed by workshop
Process cell classification followed by workshop
Procedural control model followed by workshop
Functionalities for batch control followed by workshop
Models relationship
Recipe definition followed by workshop
Recipe types
Recipe contents categories
General (site) recipe procedure followed by workshop
Master (control) recipe procedure
