Institute of Good Manufacturing Practices India®

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Certified Medical Device Quality Auditor

The programme helps the professionals and students to gain knowledge and refine their existing skills in the core area. Along with providing theoretical knowledge IGMPI also focuses on providing students the insight about how the work is carried out in industries and organization so that the coverage of knowledge is vast and practical aspect based.

The tailor-made certification provides you the tools and skills that are required to be a Medical device Quality Auditor. The guidelines for Medical Device Quality auditor focus on practical knowledge that candidates can apply in real-life scenarios. Candidates are guided so that they can gain CE marking certification for their organization under USFDA, India and EU’s latest directives for all medical devices which include: The certification also includes the review of technical document and site audits. The site audits will majorly analyze compliance with both ISO 13485:2003 and directives from USFDA, EU and India. The programme has been designed to indicate all the changes in regulatory front so that the manufacturer of the medical device can better understand the intricacies of latest USFDA , India and EU directives and guidelines that cover in vitro diagnostic medical devices and the requirement mentioned in it are for the manufacturers, Notified bodies and member state component authorities.

Audit principles covered in this training are based on the internationally recognized standards. The content is specially framed for Medical device organizations with a strong focus on what to audit and how to verify compliance. This training for members is going to provide the right tools for auditing the internal quality system e.g. medical device regulation or outside audit suppliers/contract manufacturers.

The beneficial output of this programme includes:

1. Knowledge of new regulations. 2. Practical application of EU IVD medical device regulation.
3. Detailed knowledge of effectiveness of Quality Management System in Medical device auditing field.
4. Requirement of CE marking of medical devices in USFDA, EU and India perspectives.
5. Compliance requirements for in-vitro medical diagnostic devices.
6. The purposes and business benefits of quality management system, and carious standards, audits of management system and third party certification.
7. The responsibilities and roles of an auditor required in planning, conducting reporting and following up on quality management system audit for establishment of compliance ISO 13485:2003.
8. The certification also includes the review of technical document and site audits. The site audits will majorly analyze compliance with both ISO 13485:2003 and directive 93/42/EEC. The programme has been designed to indicate all the changes in regulatory front so that the manufacturer of the medical device can better understand the intricacies of new EU IVDR and the requirement mentioned in it are for the manufacturers, Notified bodies and member state component authorities.
9. Develop knowledge and skills to conduct third party audits against the requirement of ISO 13485:2016 and report the compliance of management systems against the standard requirement so that proper action can be taken.
10. Function of internal audit in sustaining and improving management system.
11. Gather evidence by observation and sampling.
12. Report writing in compliance of management system against the audit standard.
13. Be a part of corrective action steps.
14. Better understanding of internal audits, audits of supplier and third party audits of medical devices manufacturers.

Eligibility

Any Life Science graduate/ B.Pharm/M pharm/MSc/ any diploma holder or passed outs of Clinical Research degree or diploma courses are eligible for these course. Working professionals of any of the following industry types Drugs manufacturing, Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology or any related industry are highly encouraged to apply for the programme.

Programme Duration

The candidate is expected to complete the course in 3 months.

Programme Deliverables

●   A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry's expectations.
●   Assignments for all the programme modules for continuous evaluation and guidance.
●   Interactive or recorded lectures on all key areas of the programme giving all flexibility to the participants.
●   Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
●   At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
●   All learning and training delivery initiatives shall be conducted in English.

Registration

The registration dates for this programme run by the institute are updated timely on the webpage. Effective E-learning tools incorporated into the design of the webpage make the course lectures, videos and study material easily accessible. This gives huge window of self-regulated and self-paced performance to the participants.

Certification and Membership Fees

Rs. 20,000/- for Indian nationals and 600 USD for overseas Professionals. This covers the certification registration fee and examination fee. An additional membership fee of Rs 4500/-( USD 125 for overseas) is optional to pay in order to avail the services of Certified Study Resources and training for the preparation of the certification exam.

Assessment & Certification

All the participants are expected to appear for online assessment. After successful completion the participants will be Certified as Medical Device Quality Auditor by IGMPI. For all the above mentioned elaborate study resources, Assessment test papers and case studies would be provided by the Institute from time to time to members. Details get updated on the webpage as well. The certification will be awarded after the required levels of knowledge, skills, professionalism and attitude are assessed through the IGMPI assessment process.

Re- Examination

In case the participant is not able to pass the certification exam in first attempt/exam notification, he/she will have to re- register for the next scheduled examination by submitting re- registration form along with the re- registration fee of Rs. 1500/-(50 USD). However, the participants will be given sufficient flexibility in scheduling their “First” certification exam.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc. The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare and Food industries on regular basis.

Future career prospects of Certified Medical device Quality Auditor

Certificate in medical device will provide a horizon of knowledge to support you and your organization in the path of success. It will help you understand every step of assessment and procedures so that you fully understand the subject and standards that are applied across the whole supply chain and seeks to address he entire life cycle of Medical device.


Programme Fee Details

How to apply

For further enquiries, write to or call us on::
info@igmpiindia.org/ +91 8587838177, +91 8130924488, 0120-2427175, 0120-4375280

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Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like