Loader
Course Image

Course Description

Course Description: Engineers from all disciplines play a key role in the development and manufacture of pharmaceutical products, with involvement in the design, qualification and subsequent maintenance of the facilities, utilities and equipment necessary for the various stages of production. The application of Good Manufacturing Practices to engineering and technical activities is essential to ensure that a company manufactures products of the required quality. The purpose of this course is to highlight how current GMP's are applied to pharmaceutical engineering and technical services to ensure facilities, equipment and processes are maintained to the highest possible standards expected by the Regulatory Authorities. This course will be suitable for both introductory training and as a refresher course for engineers already working in the pharmaceutical and related healthcare environments. Course Programme A key objective of the course is to ensure that delegates acquire the appropriate knowledge of the current engineering practices and technologies as they are applied within the pharmaceutical and medical device industries. Subjects that will be covered include: The role of engineering and the engineer in the pharmaceutical industry. Duties, responsibilities and the application of Quality Assurance principles to engineering services Current international GMP regulations and regulatory requirements (EU, PIC/S, US-FDA) as they apply to engineering activities Good Manufacturing Practices with respect to following key quality systems within the engineering environment Equipment specification and selection (URS) FAT's and SAT's Risk Assessment and qualification requirements Equipment qualification (DQ, IQ, OQ) Retrospective qualification of existing installations Technical change control - what constitutes a change and how it is managed Planned preventative maintenance Training of personnel Contractors - selection and supervision Controlled documentation and record keeping The manufacturing environment, including current applicable clean room standard for sterile and non-sterile dosage forms (EU GMP Annex 1, ISO 14644) System design considerations Qualification parameters as built, in operation and routine requalification Routine maintenance and calibration procedures Risks and problems associated with clean room installation and operation Services and utilities Pharmaceutical high purity water systems (design considerations, qualification and routine maintenance and calibration) Clean steam (design considerations, qualification and routine maintenance and calibration) HVAC Sterilisation Processes GMP risks and problems associated with utility installations Auditing and self inspection programmes for technical services Instrumentation and controls Control system validation Data integrity Computer system validation implications Application of GAMP requirements Cleaning and cross contamination and the impact upon engineering activities Review of current regulatory concerns with engineering and technical activities

Course Description: Engineers from all disciplines play a key role in the development and manufacture of pharmaceutical products, with involvement in the design, qualification and subsequent maintenance of the facilities, utilities and equipment necessary for the various stages of production. The application of Good Manufacturing Practices to engineering and technical activities is essential to...

Read More

Related Courses