INTRODUCTION

Healthcare Packaging is a highly technical and scientific field, requiring professionals to stay educated and well informed. Proving the necessary protection for state of the art medical devices requires packaging professionals to keep informed of ever-changing regulations, material innovations, testing requirements etc.

This one-day workshop is focused on Sterile Medical Packaging Regulatory and Standards Review, requirements after the new EU MDR as well as Packaging Engineering and Design, Peel Strength & Microbial Barrier.

Those who attend will be awarded Certificate of Training.

WORKSHOP OUTLINE

Time: 9.00am – 5.00pm

Sterile Medical Packaging Regulatory/Standards Review

  • The new EU MDR / IVDR:
    • Introduction and key considerations
    • The MDR Impact on Sterile Packaging and Global Sterile Packaging Standards
    • Harmonization of EN ISO  standards: the current issues and plans for a new CEN standardization request
  • EN ISO 11607 – Packaging for sterile medical devices- latest revisions to be published end of 2018
    • An introduction to packaging validation
    • Key issues to consider when establishing successful validation protocols
    • Summary of changes of the new EN ISO 11607 revision
  • New MDR requirements for labelling, current plans for developments of new EN ISO symbols
  • Common Materials and Package Formats in Sterile Barrier Packaging
  • Designing for Success – Packaging Design and Troubleshooting Considerations
  • Packaging Test Methods and Validation of Test Methods
    • Science of Peel Strength and effect of using different ASTM F88 techniques
  • Basics of Microbial Barrier & Particle Filtration

WHO SHOULD ATTEND?

This workshop is recommended for those who are involved in R&D and Manufacturing Operations, Packaging and Process Engineering, Procurement and Supply Chain Management, Quality Control and Regulatory Affairs, Marketing and Product Management as well as Sterilization Professionals and Lead Auditors.

TRAINERS’ PROFILE

Thierry Wagner is the Regulatory Affairs Director-Europe, Middle East & Africa for DuPont™ Tyvek® Medical & Pharmaceutical Packaging. Thierry has spent the past 30 years working for DuPont in its polyester films and non wovens businesses in a variety of assignments ranging from process development and project management to operations and business management.

Kevin Grum is part of DuPont’s Medical and Pharmaceutical Packaging team and supports global applications development. Over the past ten years, he has held a variety of roles within DuPont; including manufacturing, quality, and sales.

REGISTRATION DETAILS

WORKSHOP FEES

Early Bird Registration (by 05th July 2018) – INR 500+GST (INR 590 Only)
Normal Fees (from 05th July 2018 onwards) – INR1000+GST (INR 1180 Only)

PAYMENT AND CONFIRMATION OF REGISTRATION

Registration will open soon!
An invoice will be sent to you within 3 working days upon your registration.
Please note that any Early Bird Discounts (for registration within validity period) will be reflected on the invoice.
Please get in touch with us (nadeem.anam@mtaiindia.org / afraz.alam@mtaiindia.org)

CANCELLATION / REFUND POLICY

AMMI reserves the right to cancel or postpone any training or event but with due notice to the registered participants / company(s). Any payment made will be refunded in full if the cancellation is made by MTaI. No shows and cancellations made by participants/ companies within the specified period will incur the specified costs as per below schedule.

Prior to Training Date Cancellation Charges
30 days or more No charges
15-29 days 25% of training course fee
8 – 14 days 50% of training course fee
0 – 7 days 100% of training course fee
SUBSTITUTION

Replacement of participant is allowed at no additional cost if you are unable to attend. Please inform us of the replacement in writing at least 3 working days before the training date.

CONTACT US

For enquiries, please email to:
Nadeem Parvez Anam
nadeem.anam@mtaiindia.org
Tel: +91.124.4002801-02
Mobile: +91.9958548969

Mohammad Afraz Alam
afraz.alam@mtaiindia.org
Tel: +91.124.4002801-02
Mobile: +91.8826200737

VENUE

Shangri-La’s Eros Hotel, New Delhi
19, Ashoka Road, Janpath, Connaught Place,
New Delhi, Delhi 110001, INDIA