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.
Any Graduate/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHMS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.
The registration dates for this programme run by the Institute are updated timely on the webpage. Effective Online tools incorporated into the design of the webpage make the programme lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.
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.
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.
Membership will be valid for two years and may be renewed by the participant by submitting membership renewal form and membership fee after two years. The Institute reserves the right to conduct an assessment before renewal.
Each participant has to take membership of Institute of Good Manufacturing Practices India (IGMPI) as a part of registration process. All the members will be entitled to receive comprehensive study resources for all the modules along with training guidance in online interactive mode. The membership certificate will also be issued to successful candidates along with their certificate of the professional certification.
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 like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Bliss GVS Pharma, SeQuent, Mankind, Beryl Drugs, Allergy Therapeutics, 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 industries on regular basis.
Medical Devices Industry is highly alluring sector now a days. Hence, there is fierce competition in this sector. Proper training and knowledge in this field is required to ensure design requirements incorporate the defined service strategy/serviceability, participating in design and program reviews to optimize implementation. Certified Medical Device Quality Auditor by IGMPI, open doors for entry into the industry which endows theoretical as well as practical knowledge to the candidate required to sustain successfully in industry. After the completion of this programme the candidate gets selected as Medical device Quality Assurance Manager, Regulatory Affairs Manager, Quality Auditor, Quality Assurance Compliance Specialist, Medical Devices Specialist etc.
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Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like