■ You can ask yourself often worry annoyance the following questions?
■ Whether or not You currently feel the drug production supervision form changes quickly, Not able to readily understand and grasp the new regulations require moreover misery?
■ Your existing management personnel's work ability can not meet the requirement of the regulations, Always cannot solve the laws and regulations the questions execute an difficult?
■ In the process of audit every year, always can't find defects, but in the GMP certification examine can always find so many problems?
■ Whether or not you because enterprise staff ability not enough,always at a crucial moment when the need for to solve the such as laws and regulations, production and so on problem, always let you down the situation will appear!
■ Do you whether worry about drug production quality, Afraid of problems cannot be solved!
■ Whether or not you because the enterprise staff's ability is not enough, need to give them offer help, improve their work ability, for the enterprise to establish perfect management team in the future!
■ Whether or not you because enterprise the present supervision mechanism is not perfect, The Enterprise management process nobody tracking, Always because of the production management goals cannot achieve and that anxiety?
■ Whether or not you feel certification has been through many years, But the risk of drug quality problems have not been able to be improved and the quality of the products also don't know how to effectively control?
■ Whether or not you certificate has got, but can't improve Production efficiency? And did not bring economic income and thinking?
……
Therefore, Beijing GELEG recently launched “Consultative Advisory Services” Content covers every aspect of the pharmaceutical industry, the attention pharmaceutical industry quality management system and the growth of the pharmaceutical enterprise. GELEG according to the situation of pharmaceutical industry in China, pursuant to the FDA、 EU、 WHO、ICH, and so on requirement, developed a series of training courses, will outstanding management consciousness Spread to the pharmaceutical industry. thereout to help guide the Chinese pharmaceutical enterprises to reduce costs, improve product quality. Help enterprises to achieve success.
Our aim is to: help enterprises to improve the quality of employees, to establish perfect quality management system.
Consulting service concept:
The implementation of protocol through the practical management, the effect of tracking, help customers to establish an effective quality management system.
Help customers to establish an effective management system ,implement quality management and production operation management interinfiltration,to achieve enterprise regulations compliance and the production benefit a win-win situation.
Through the “training and consulting” services mode,help customers to build a high-quality staff team.
Through the Based on the research of the international quality standards, help customers to establish an effective quality management system,for the enterprise to establish the foundation of international certification.
Advisory service content:
Service 1:Training
To the quality management system targeted audit, According to the actual situation of enterprises, conduct a comprehensive audit, The results of the audit to conduct a comprehensive analysis and guidance, with the actual situation of enterprises to conduct a comprehensive tracking adjustment, For the enterprise quality management system and production management level of continuous improvement, lay a solid foundation.
Training topics: According to the results of the audit requirements tailored for the client, Can also according to customer request make the formulate training content, In addition, you can select training content in the training list. (see attachment)
Service 2:Validation
The development of quality management system authentication technology, drug quality management system an important milestone,validation is to ensure that the production process is stable and reliable means of science. Through the validation, the pharmaceutical enterprises can reduce the quality cost, to obtain better economic benefit; For drug quality provides a reliable guarantee.
Specific content:
Strengthen the validation training;
Guide customers compile revalidation and Change the validation protocols;
Guide customers implement revalidation;
Guide customers risk assessment and deviation control;
Guide customers revalidation report and risk control;
Service 3:Audit
How about in the law of the allows scope organization drug manufacturing, every pharmaceutical companies need to consider. how to through the audit,Understanding and verification company whether there is the of violation of the quality management system phenomenon. how to through the audit, find out all application materials, Whether the site condition consistent, data information whether are accurate, true and reliable.
Specific content:
Special training(see attachment training content);
Guide the customer compile audit plan;
Lead the customer to carry out the audit work;
Issue the audit report and capa;
Track audit results;
Assist the customers in conduct supplier audit;
Service 4: Document Optimization
Information unobstructed is to improve the work efficiency, therefore, in the process of production management, should be constant summary analysis, If you choose to modernization computer management mode, will to optimize workflow improve production efficiency, optimize the document, reduce the labor intensity of workers. specific content of the service:
Help customers tease workflow, establis hflow chart;
To establish risk identification and control system;
Analysis of work flow and optimize working process;
Help the customer conduct file system analysis;
Choose the need to revise documents;
Documents revisions for organization personnel;
Review revised documents, improve applicability of the documents;
Service 5: Quality Analysis and Assessment
Quality analysis and evaluation is the quality development trend the decide, Reduce the quality risk and costing loss, already happen the quality deviation and accidents, etc, assist customers with conduct system investigation and risk analysis, establishing reasonable CAPA.
Specific content of the service:
Assist customers with the annual review、deviation、change assessment analysis;
Participate in quality accident investigation and analysis;
Training of quality statistics method;
The evaluation of the quality risk management and training;
Organization QS team, quality of the improvement;
Service 6: Technical Management
To analyze the quality problem of the enterprise and optimization, help enterprises to cultivate a number of highly qualified professionals,To establish a reliable quality assurance system.
Specific content of the service:
Assist enterprise to conduct validation professional choice, set up a batch of high level validation team;
Assist enterprise to conduct audit professional choice, set up a batch of high level audit team;
Assist enterprise to conduct Quality assurance system professional choice, set up an effective quality assurance system;
To carry out the project management training;
Service 7: Other Production Quality Activities
All the activities of the production quality,are we need to focus on activities。
Specific content of the service:
Provide customers with the latest laws and regulations,to assist the customers to solve the problem;
Customers to buy new equipment, to assist the customers to evaluate;
Assist the customers to supplier audit;
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