Source: http://antrix.com/services/service_list/2_quality_regulatory_training.htm
Timestamp: 2019-04-20 12:36:22
Document Index: 479295947

Matched Legal Cases: ['art 11', 'art 820', 'art 211', 'art 211', 'art 211', 'art 211']

The service ensures employees receive appropriate Initial and on-going Quality System Regulation, International Organization for Standardization (ISO), Companies Quality Manual and Internal Standard Operating Procedures training as per training procedure.
Training service covers QSR/ISO 13485:2003/Internal Quality Systems requirements for methods and controls used in, the manufacture, packaging, labeling and storage, of finished medical devices. Training can be made in the form of a discussion, lecture, self read materials, seminar or conference.
We will document initial training which all employees must attend within one month of employment and On-Going Training which an employee is responsible to make sure that they are trained when significant changes occur to the Quality Systems.
$Savings > 30 % > 60 % > 80 %
Training can be customized in any of the formats as below:
Instructor Led Course: Training provided by a qualified individual/subject-matter expert.
Outside Training: Educational programs provided by outside services, including degree or certificate programs provided by colleges or universities, or seminars/conferences provided by topic experts.
On-the-Job Training: Training accomplished by actually performing the required task under the supervision of a qualified individual.
Independent Review / Self Read: Training accomplished by individually reviewing training materials. Completion of an independent review by an employee must be documented and acknowledged in writing by a qualified individual or the employee’s manager.
We can also document a training procedure that employee needs to follow covering:
Assessment of Employee Competency
Job Specific/Departmental Training to ensure that all personnel are qualified and/or trained to competently perform duties specific to their assigned responsibilities
Training record to be completed to confirm successful
Completed training records are maintained by the department manager or a designee or training database to ensure integrity
ISO and FDA Training Modules Available
Quality System Regulation for Medical Devices Overview
ISO 13485:2003 - Implementing the ISO Quality Management System (QMS) for Medical Device Organizations
ISO QMS Implementation Tools and Techniques
Preparing and Submitting 510(k) - Premarket Notification & PMAs (Pre-Market Approval)
Title 21 CFR Part 11 Compliance and Assessment
Nonconformance's (NCMR) Management
Auditing (Internal, Notified Body, FDA)
Obtaining ISO Certification and IVD Registration
Obtaining CE Mark
Manufacturing Process Controls and Validation
Validation of Computer System Used in Production and/or Quality Systems
Customer Complaint Handling and Medical Device and Vigilance Reporting
Product Recalls, Corrections and Removals
820.25 (b)Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
Title 21 CFR Part 820.25 – Personnel Training
ISO 13485, section 6.0. – Resource Management
Title 21 CFR Part 211.22 - Responsibilities of quality control unit
Title 21 CFR Part 211.25- Personnel qualifications
Title 21 CFR Part 211.28 - Personnel responsibilities
Title 21 CFR Part 211.34 - Consultants
Title 21 CFR Section 806 - Medical Devices, Reports of Corrections and Removals
Title 21 CFR Section 810 - Medical Device Recall Authorities