19:37 | Bsb, 9/4/2010
 
personnel qualification
         
     
  Personnel Qualification >>
 
 

Visanco is at your disposal to evaluate and propose, in advance, the best personnel qualification structure for your company or institution, aiming to reach the best results.

Visanco has a technical specialized staff, with a vast academic experience, for the formulation of actions in the direction of promoting healthy and appropriate nourishment, by means of providing conceptual and strategic subsidies that foster the harmony among company, government and society.

Below there are some themes of courses provided by Visanco.

Food and Nutrition Field:

Pharmaceutical Field:




Food and Nutrition Field


Manufacturing Processes with emphasis on GMP and HACCP

The objective of this training is the application of Good Manufacturing Practices and Food Sanitary Quality concepts with the development and deployment of a Quality Assurance Program based on the application of the Hazard Analysis Critical Control Point (HACCP) method and national and international sanitary rules, covering all the set of measurements that must be adopted by the food industries. This course is directed to food establishment owners, students, and professionals in the field of food who are acting in the manufacturing of products and quality control.


Sanitary Legislation with emphasis in Food – registration of products, regularization of companies, sanitary infractions

Personnel Qualification for the comprehension and elaboration of general and nutritional labeling for food products; research and analysis of food basic legislation and specific technical guidelines; fitting of food products in categories and subcategories regulated by ANVISA and the Ministry of Agriculture; critical action on the analysis of sanitary infractions, comprehending the knowledge of deadlines, competent entities involved, and rights and duties of companies subjected to sanitary control. This program is aimed to students and professionals acting in the food sector oriented to the regulatory area.


Healthy Nourishment

Focus on present perspectives of Health and Food Safety, with proposals and directives for adequacy to Global Strategy for Healthy Nourishment, and Healthy Nourishment Promotion based on current determinations of international bodies, World Health Organization, and the Ministry of Health. The course is directed to the general public interested in healthy nourishment, people who exercise, teachers, and students, among others.


School Nourishment

Focus on the implementation of guidelines proposed by Administrative Order n.º 1010, May 8, 2006, with the propagation and promotion of the Healthy Nourishment in Elementary, Primary and High Schools, in public and private systems, in national scope; analysis and discussion about several factors, including behavioral, environmental and genetics, which influence the increasing of child obesity levels and overweight in the childhood as a result of the negative balance between calories consumed by children and their energy expenditure necessary for regular growth and development, metabolism, and physical activity. Also for elucidations concerning the School Nourishment National Program (PNAE) and its interface with health and food availability to elementary and primary schools, and governmental actions in municipal, state and federal levels. The theme proposed is appropriate to health professionals acting in schools, teachers and school principals, and other agents involved with PNAE.

Pharmaceutical Field

Manufacturing Process, with emphasis in GMP

The course is directed to personnel qualification of managers and other collaborators of various sectors of the pharmaceutical industry, cosmetics, sanitizing products and health products aiming the planning, implantation and maintenance of the Good Manufacturing Practices, which constitute a quality system directed to critical processes. The course covers stages of elaboration, emission, traceability, control of documents and of registries, processes cards, orders of production, responsibilities, clothes and hygiene, cleaning, flow of personnel and of material, cross contamination, control of processes, facilities and utilities, training, performance index use, and risks analysis.


Productive Processes Validation

Validation is worldwide recognized as one of the most important tools in quality assurance systems and it constitutes an essential part of the Good Manufacturing Practices. Validation means the elaboration of documented evidences, which confirms that any procedure, process, equipment, material, operation or system, in fact, leads to expected results. This is a course directed to professionals that act in the fields of quality, development, validation, systems, engineering and production. The course approaches the foundations, philosophy and organization of the validation, and specific themes like the elaboration of master plan validation (MPV), protocols, check lists and productive processes reports of sterile and non-sterile pharmaceutical forms.


Water Systems Validation

This course is focused on systems validation methods considered critical for water acquisition for pharmaceutical use. The course approaches theoretical basis for validation, discussion of requirements for different water treatment systems, purification methods, kinds of water and its applications, sanitizing and bioburden, phases of the validation study, seasonality, analytical methods, procedures elaboration, protocols and reports according to recent guidelines of ANVISA, WHO, USP and FDA. The course is directed to professionals that act in the field of quality, production, development, engineering and validation, as well as to professionals and students in the academic field.


Air Validation

Critical systems of air conditioning and treatment (Heating, Ventilation and Air Conditioning – HVAC) should be validated in order to attend the requirements established by Good Manufacturing Practices and by national and international technical guidelines and recommendations. This is a course directed to the personnel qualification of professionals acting in the field of quality, validation and production. It aims to provide theoretical review, to guide the elaboration of protocols and reports of qualification and validation, standard operational procedures, application of inspection schedule and of critical points evaluation guides, and HVAC systems monitoring and maintenance.


Analytical Methodology Validation

The analytical methodology validation has direct impact over the Good Manufacturing Practices and Quality Control and it should provide documented evidence of the adequacy of a method to its purpose. This course is directed to the personnel qualification of professionals acting in the field of microbiological and physical-chemical quality control, regulatory affairs, research and development and universities. The aim is to clarify matters related to terminology, strategy and analytical management validation, uses of current national and international directives, pharmacopeias, co-validation, application of Good Laboratory Practices (GLP), evaluation of critical points, treatment of the most common problems, elaboration of validation protocols, training and revalidations reports.


Cleaning Validation

The course is directed to professionals in the field of quality and production, which focuses in the terminology and strategies used to develop, implement and manage a cleaning validation program directed to equipments and areas. Issues related to identification and resolution of non-conformities in potential, cross contamination, cleaning and sampling methods, documentation and information traceability, analytical methodology, elaboration of protocols and reports, training and adoption of revalidation criteria according to the most recent national and international directives accepted by ANVISA are also treated in this course.


Quality Assurance

This course covers the totality of orders that should be taken based on Good Manufacturing Practices, in order to assure that drugs, cosmetics, sanitizing products and medical devices are being projected, developed and produced under the quality, safety and effectiveness patterns. The main topics are: philosophy, quality systems planning and implantation, organogram and flow chart, cross contamination, documentation, control and traceability of the information, GMP and GLP, validation, quality tools, treatment and risk analysis of non-conformities, auto-inspection and training according to the most recent national and international directives officially adopted.


Quality Control

The quality control applied to the production of drugs, cosmetics, sanitizing products and health products is inserted in the Good Manufacturing Practices policy, and it is responsible for the guarantee that raw materials are not released for use neither the products are released for sale nor supplying until their quality is judged satisfactory. Therefore, this course is based on strict national and international norms and quality patterns officially adopted. It will be covered themes related to: structuring, maintenance and management of a Quality Control laboratory; elaboration and traceability of documents; elaboration of specifications; SOPs; analysis registry; treatment of non-conformities; risk analysis; good laboratory practices; training; calibration; qualification; and validation.


Qualification of Suppliers and Service Providers

The raw material acquisition and outsourced services utilization are decisive factors for quality assurance maintenance of pharmaceutical products, cosmetics, sanitizing products and health products. This course is directed to professionals in the fields of supplies, quality assurance, research and development, production and quality control.
Based on the most recent national and international norms, the course aims to implement an effective quality system guided for the elaboration of procedures and scripts to put into practice auditing, history evaluation of suppliers and services providers, quality indexes measurement, and non-conformities treatment in order to promote constant improvements in the partnership between clients and suppliers, and in the accomplishment of the good manufacturing practices.


Quality Control Outsourcing and Productive Process Stages

The course is focused on recent norms of ANVISA and directed to companies and professionals that hire or outsource services on production of drugs, quality control and storage. The aim is to base and debate points related to legal and sanitary requirements, accomplishment of good manufacturing practices, quality control and storage, outsourcing in the scope of Mercosul, contractual evaluations, definition of responsibilities, and elaboration of forms and of outsourcing notice to ANVISA.


Sanitary legislation with emphasis on Drugs, Cosmetics, Sanitizing and Health Products – registration of products, regularization of companies, sanitary infractions, and certifications

Any activity which involves manufacturing, import, distribution, storage and transport of pharmaceutical, cosmetic, sanitizing products and health products demands a minimum and necessary know-how of current sanitary legislation. The large number of technical regulations, sanitary infractions, regulatory requirements (licenses and registrations) and administrative procedures makes it difficult the understanding of channels for the complete regularization of companies and products along with the legal sanitary entities. Thinking on that, this course will be guided to the personnel qualification and improvement of professionals that act in companies or entities that work with products subjected to sanitary control, mainly in the fields of regulatory affairs and quality control, enabling the historical analysis of sanitary legislation and of legal framework, as well as the sanitary legislation updates, its interpretations, and doubts.


Technology Transfer Processes in Pharmaceutical Products

Directed to professionals acting in the fields of management and regulatory affairs, R & D, production and quality, this course aims to establish conceptual basis and practical aspects related to technology transfer means aiming to support the development and the improvement of technological, operational and managing capacities, of personnel qualification, of learning culture, as well as the support to situations and segments of the market facing the increasing demand for production processes technology transfer.

 
 
 

 
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