Pharmaceutical Auditing Training (IRCA), Integrated Management Systems

JEMO Ltd

JEMO Ltd provides specialist training and consultancy assistance in the following areas: 

  • Internal (self inspections) and supplier Lead Auditor training
  • Pharmaceutical systems auditing services
  • Documentation and implementation of management systems to certification standards (e.g. ISO 9001, EU GMP, PS 9000; ISO 13485; ISO 15378 etc.)
  • Integration of systems (IMS) including environment (ISO 14001) and health and safety (OHSAS 18001)more
Process mapping and documentation Continual improvement, including cost and efficiency savings

The company operates worldwide and has particular expertise in working with the Chinese language and culture.

Lead Auditor Training

Our unique 5-day Pharmaceutical supplier / internal lead auditor training course is registered by the International Register of Certificated Auditors (IRCA). This shows people how to perform professional audits in suppliers to the industry. It includes primary and secondary packaging, printed components and non-active ingredients (excipients).

Following continuous assessment and written examination, successful completion of the course fully satisfies the training requirements for IRCA registration. Two certificates are awarded. We also provide an after course support service in practical auditing.

Pharmaceutical Auditing Services

We offer a comprehensive package of internal and supplier pharmaceutical auditing services from professionally qualified auditors up to and including the highest grade of IRCA Registered Corporate Auditor. The auditors work for accredited certification bodies and are fully up to date with their latest approaches.

Implementation of Management Systems

We assist companies in the implementation of management systems to obtain systems approval from external certifiers, with a track record is “first time pass”. We use a hands-on approach to enable our clients to obtain tangible business benefits including cost savings, improved efficiency and waste reduction. We can cover most international standards including GMP, PS 9000, PS9100, ISO 15378, ISO 13485 etc.

Integrated Management Systems

We show companies with established quality management systems how to benefit from integrating this with their systems for environmental and health and safety management. We provide a comprehensive package which includes training of operational and auditing staff.

Pharmaceutical Process Mapping and Improvement

We concentrate on understanding and developing the processes by which companies maintain operation and control. We start by training operators, staff and managers to understand and map their pharmaceutical processes and the interaction with others, and then to locate and improve the aspects which cause waste and inefficiency. Typically this approach can result in cost savings of 10% of annual turnover with increases in capacity and efficiency.less

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JEMO Ltd
11 Willowbank
SN14 8QG, Chippenham
United Kingdom

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