Training

Training is a key requirement for all regulatory bodies around the world. All personnel related to quality shall be trained and the training contents shall be in accordance with the jobs. There shall be training on related regulations, duties of the corresponding positions, and professional skills, and the actual training results shall be assessed regularly.

PharmaBioSolutions consultants have been providing training for large number of Pharmaceutical companies around the world.

Training

GAMP5 Training

Electronics Records and Electronics Signatures (ERES) Training

ISA S88 Training

GAMP5 Training

Introduction to GAMP5 covers GAMP5 history, key concepts and categories

Introduction to URS followed by workshop

Vendor Audit

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 discusstion

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

Training courses offered by PBS have the following features:

● Highly modular. Training courses are designed to be highly modular. This will help the clients to select the modules appropriate for their engineers and experience

● Tailored. 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.

● Interactive. 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.

● Flexible location. 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.

● Bilingual in Chinese and English. Training courses will be delivered in both English and Chinese and training material will be also in both English and Chinese.

Validation

GMP Consultancy

OEM Consultancy

Training

Training

Training