(14 May 2019) – VENTURE BASE CAMP ON ISO 13485:2016 Medical Devices Quality Management – Internal Auditor Training Course – on 28, 29, 30 May 2019

Venture Base Camp on

ISO 13485:2016 Medical Devices Quality Management Internal Auditor Training Course

When? – Tuesday, Wednesday, Thursday | 28,29, 30  2019 | Time: 0900 – 1800

Where? – Lecture Theatre, Venture Center, 100 NCL Innovation Park

Queries? – Lipika Biswas |020-25865875/76/77|eventsdesk@venturecenter.co.in

FlyerOutline |Report 

Job Opening: QA&RA Intern (Medical Devices/ Pharma)

Position QA RA Intern (Medical Devices& Pharma)
Location Pune
Apply Click here to submit the form

For: IInd Year, Biomedical Engineer, Masters in Pharmacy – Quality Assurance Techniques/ Regulatory Affairs.

Grab the learning opportunity of overall quality and regulatory management system of medical devices. Complete Industrial dissertation (thesis) work with and gain practical knowledge and techniques by hands-on experiences on establishing the QMS.

Proposed project title: Establishing Quality management systems for medical devices (Requirements for regulatory purposes) as per — ISO 13485: 2016.

 Would you take the responsibility of highly regulated and dynamic industry?

You will learn and be responsible for the creation, implementation, organization, and maintenance of the Quality Management System (QMS) documents in the Regulatory Information and Facilitating Center (RIFC) at Venture Center, Pune. You will learn and oversee all the aspects of QMS document control/ management. The field of responsibility includes all elements regarding the Quality Assurance and associated operations for facilitating functional and dynamic cleanroom facility to startups in the MedTech sector.

 

What will you be doing day to day?

  • Drafting quality assurance policies and standard operating procedures as per ISO 13485.
  • Maintain the integrity of documents, store documents, and provide administrative assistance.
  • Controlling, maintaining and updating the quality system documents.
  • Evaluate audit findings and implement appropriate corrective actions.
  • Coordinating and supporting on-site audits conducted by external providers/ startups.
  • Assist, guide, train and help startup clients in QA activities during the cleanroom facility lease period.
  • Coordinating IPQA activities at shop floor from dispensing to the packaging of devices.
  • Scheduling and coordinating the cleanroom validation plans, equipment validation and calibration plans.
  • Ensuring that planned/ unplanned changes or deviations are documented, reviewed and analyzed, and recommending studies, tests or validation activities to be performed.
  • Monitoring and recording cleanroom operational systems as per the regulatory requirements.
  • Ensure cleanliness of the cleanroom and maintain the work environment needed to achieve conformity to product requirement.
  • Advocating continual improvement of operations and the quality system.
  • Ensuring all time readiness for audits.
  • Assisting in the internal audit team for each department, interacting with auditors during external, internal and customer inspections, and intimating management of the observations.

You should have knowledge and skills:

  • Applicable procedures, specifications, standards, and regulations (ISO 1345, ISO 14971, USFDA, EUGMP, etc.)
  • Editing, proofreading, and grammar skills, and expertise in Microsoft Word, Outlook and Excel is must.
  • Should be able to work independently or in a team environment, pay attention to detail, have excellent organizational skills, and have excellent time management skills.

Educational Requirements:

IInd Year, Biomedical Engineer, Masters in Pharmacy – Quality Assurance Techniques/ Regulatory Affairs.

Period:

One year.

 Benefits to the inter during the project:

Discover the medical device industry’s most popularly adopted international standards for quality management, ISO 13485. The ISO 13485 standard is a powerful solution to satisfy the general requirements for a QMS. Adopting ISO 13485 provides a solid foundation for manufacturers to address the Medical Device Directives, regulations, and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide a product, including quality management system-related services to such organizations.

Perks:

Certificate/ Letter of recommendation, Complete Industrial dissertation (thesis) work.

(16 Jan 2019) – VENTURE BASE CAMP ON REGULATORY PROCESSES AND CERTIFICATIONS on 5, 6, 7 Feb 2019

Venture Base Camp on

Regulatory Processes and Certifications

– Make your own regulatory roadmap in 3 intense days! –

 

Pre-workshop: Assistance and basic roadmap from RIFC team.

 

During Workshop: Listen–Learn–Discuss–Make a strategy–Present–Get a chance to win the PRIZE WORTH 50,000 INR ISO standards for two participants.
Travel fellowship: VC Incubatees, BIRAC Grantees who are small entities  — Avail Travel fellowship up to 13,000 INR.
 

When? – Tuesday, Wednesday, Thursday | 5, 6, 7 Feb 2019 | Time: 0900 – 1800

Where? – Lecture Theatre, Venture Center, 100 NCL Innovation Park

Queries? – Lipika Biswas |020-25865875/76/77|eventsdesk@venturecenter.co.in

Flyer |  VBC Outline |Report

(15 Nov 2018) Mini-Workshop Series on Regulatory Requirements for Medical Devices – 002 on 08 Dec 2018

Mini-Workshop Series on

Regulatory Requirements for Medical Devices

HOW TO WRITE A QUALITY MANUAL?

Good Documentation Practices, SOPs, and Quality Manual

When? – Saturday, 08 Dec 2018 | Time 1345-1830 Hrs

Where? – E – Class Room, Venture Center, 100 NCL Innovation Park

Queries? – Lipika Biswas |020-25865875/76/77|eventsdesk@venturecenter.co.in

Flyer |  Workshop Outline | Workshop Feedback

(08 Oct 2018) Mini-Workshop Series on Regulatory Requirements for Medical Devices – 001 on 26 Oct 2018

Mini-Workshop Series on

Regulatory Requirements for Medical Devices

How to become an ISO 13485 Certified Medical Devices Company?

Topic: Introduction to ISO 13485 and QMS Implementation Strategy

When? – Friday, 26 Oct 2018 | Time 1345-1730 Hrs

Where? – Lecture Theatre, Venture Center, 100 NCL Innovation Park

Flyer |  Workshop Outline | Workshop Feedback 

(30 July 2018) Report of R-Clinic at Pune held on 28 July 2018

Report on R Clinic  (R-Clinic-FY1819-02)

BIG Conclave 2018, Venture Center, Pune

RIFC’s second R Clinic organized on 27th July 2018 at the BIG Conclave 2018, Venture Center, Pune. It was an interactive session between participants who are BIG grantees and “experts in the regulatory field.”

R Clinic themed on the “Awareness on the current Regulatory requirements for Medical Devices in India” and “Overview of the regulatory requirements for Clinical Trials for Medical Devices in India.”

Ms. Syamni Sasidharan, Quality Assurance Executive from MolBio Diagnostics Pvt. Ltd., Goa. She spoke on the salient features of medical devices, including classification, working of licensing clearance system (Authorities, officers, and bodies) and product recalls on knowledge of risk to safety. Regulatory requirements for GMP manufacturing site, and post-approval regulatory mandates.

Dr. Prasad Kulkarni, Medical Director, Serum Institute of India Ltd., Pune. He highlighted the current Indian Drug Regulatory System, Apex/Committee, and their functions. He described the prior requirements for the clinical trials in India. Clinical trial phases, costs, and process flow as per the Schedule Y of D&C Act and its rules. He has pointed at the global position of India in the clinical trials market.

The overall feedback received was positive, though there are certain areas where the entrepreneurs would like more information like IVD devices, clinical performance requirements and willing to have a one to one talk with the regulators to clear specific queries apart from the acts and rules. Also, few participants are keen to undergo/ join a workshop on the particular processes of regulatory needs.

RIFC will be communicating with the entrepreneurs further to resolve their queries and work on the suggestions in the upcoming R Clinic.

Some of the pointers for our next R Clinic would be:

  1. One to one talks with regulators.
  2. Case studies group discussion on documentation requirements for clinical investigation, manufacturing for sale and risk management.

Navnath Kadam
RIFC, Venture Center, Pune

(12 July 2018) Report of R-Clinic at Chennai held on 10 July 2018

Report on R Clinic  (R-Clinic-FY1819-01)

Golden Jubilee Women’s Biotech Park (GJBP), Chennai

RIFC’s first R Clinic organized on 10th July 2018 at the Golden Jubilee Women’s Biotech Park (GJBP), Chennai, as a part of the “BIRAC TiE WinER program” under the initiative of BIRAC’s Regional BioInnovation Center (BRBC) at Venture Center. It was an interactive session between the “women entrepreneurs,” who are final participants of TiE WinER Award and “experts in the regulatory field.”

Wherein, it addressed the regulatory requirements and roadmap for securing the regulatory approvals, importance, and valuation of voluntary certifications in marketing a product in various jurisdictions. Also, the event enlightened the QMS, documentation requirements, identification, and mapping of applicable standards& guidelines.

Ms. Syamni Sasidharan, Quality Assurance Executive from MolBio Diagnostics Pvt. Ltd., Goa. She focused on the certification requirements, licensing process flow manufacture for sale or distribution, for In Vitro Diagnostic medical device and addressing the queries of licensing authorities under the new Medical Devices Rule 2017 of the D&C Act 1940 and the planning and preparation of Quality Management System as per ISO 13485:2016. She also clarified the route for clinical investigation of medical devices and clinical performance evaluation of In Vitro diagnostic medical device.

Mr. Anil Chaudhari, CEO of Operon Strategist, Pune. He explained the importance of Design Control at the early stage of product realization could avoid the post-market design changes, which ultimately lead to the business continuity and saves re-design cost. He showcased real-world examples of product recalls due to improper design, ignoring the user needs, not considering the historical incidents of relevant devices. A journey of Design Control as per 21 CFR 820.30 was an eye-opening for new entrepreneurs, where they understood the design input-output, a difference between verification and validation.

The overall feedback received was satisfactory, though there are certain areas where the entrepreneurs would like more information namely how to take their processes further and the companies/agencies that can help them with their entire regulatory process.

RIFC will be communicating with the entrepreneurs further to resolve their queries and or direct them to the appropriate consultants.

Some of the pointers for our next R Clinic would be:

Focus on areas of Biologics, Therapeutics, and drugs.
Cost vs. Compliance.

Navnath Kadam
RIFC, Venture Center, Pune

(7 July 2018) Advisory service launched

RIFC is pleased to announce the launch of its first advisory service. RIFC shall start with a basic advisory service to guide entrepreneurs. In the coming months, many more services will be launched. RIFC aims to inform and facilitate regulatory approvals for bio-entrepreneurs. It will work closely with experience entrepreneurs, experts, consultants and regulators to achieve this goal.

More details on services: http://rifc.venturecenter.co.in/services/