Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959
 info@antrix.com

Quality and Regulatory Training

1. Service Description

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.

There will be productivity increase and cost savings of more than 80% using our service. Your company will save money from several thousand to millions of dollars adding to your bottom line profit.

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.


2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our service based on the company size is provided in the Table 1.0.

Projected savings is based on

  1. Process efficiency gains (people)
  2. Less personnel requirements (people)
  3. Infrastructure efficiency gains (systems)
  4. Infrastructure validation and maintenance (systems)
  5. Delivering quality products
  6. Avoid regulatory noncompliance cost
  7. Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size Small Medium Large
$Savings > 30 % > 60 % > 80 %
Annual Sales < $100 million $100 million < Sales < $500 million > $500 million
Number of Submissions <= 2 per year 2 < Sub <= 4 per year > 4 per year

Table 1.0 - Amount of money saved by your company on using our service. Company size is based on annual sales as per FDA classification.


3. Solution Approach

Training can be customized in any of the formats as below:

  1. Instructor Led Course: Training provided by a qualified individual/subject-matter expert.
  2. 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.
  3. On-the-Job Training: Training accomplished by actually performing the required task under the supervision of a qualified individual.
  4. 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

  1. Training Plan

  2. Job Specific/Departmental Training to ensure that all personnel are qualified and/or trained to competently perform duties specific to their assigned responsibilities

  3. Training record to be completed to confirm successful  

  4. Completed training records are maintained by the department manager or a designee or training database to ensure integrity

ISO and FDA Training Modules Available

  1. Quality System Regulation for Medical Devices Overview
  2. ISO 13485:2003 - Implementing the ISO Quality Management System (QMS) for Medical Device Organizations
  3. ISO QMS Implementation Tools and Techniques
  4. Preparing and Submitting 510(k) - Premarket Notification & PMAs (Pre-Market Approval)
  5. ISO 14971 Risk Management
  6. Title 21 CFR Part 11 Compliance and Assessment
  7. Document Control and Records Management in Regulated Environments 
  8. Good Documentation Practices
  9. Design Controls
  10. Identification and Traceability
  11. Corrective Action and Preventive Action (CAPA)
  12. Deviation Management
  13. Nonconformance's (NCMR) Management
  14. Auditing (Internal, Notified Body, FDA)
  15. Obtaining ISO Certification and IVD Registration
  16. Obtaining CE Mark
  17. FDA Inspection
  18. Manufacturing Process Controls and Validation
  19. Validation of Computer System Used in Production and/or Quality Systems
  20. Software Validation
  21. Customer Complaint Handling and Medical Device and Vigilance Reporting
  22. Product Recalls, Corrections and Removals

4. Definitions

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.

(1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.

(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

211.25 Personnel qualifications.

(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

(b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.

(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.


5. Applicable Laws, Regulations and Standards

  1. Title 21 CFR Part 820.25 – Personnel Training
  2. ISO 13485, section 6.0.  – Resource Management
  3. Title 21 CFR Part 211.22 - Responsibilities of quality control unit
  4. Title 21 CFR Part 211.25-  Personnel qualifications
  5. Title 21 CFR Part 211.28 - Personnel responsibilities
  6. Title 21 CFR Part 211.34 - Consultants
  7. Title 21 CFR Section 806 - Medical Devices, Reports of Corrections and Removals
  8. Title 21 CFR Section 810 - Medical Device Recall Authorities