The GeorgiaBio Event on Quality Management System and MDSAP

08/17/2017

The GeorgiaBio Event on Quality Management System and MDSAP: A global approach to quality systems, auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.

The goal of the Medical Device Single Audit Program (MDSAP) is to provide for more effective, efficient and less burdensome regulatory oversight of the quality management systems of medical device manufacturers. The implementation of the MDSAP is intended to allow for a single audit to satisfy the regulatory requirements of the participants.

Industry Leaders from Halyard Health and Datalynx US CEO Manoj Karamchandani will discuss their view points and lessons learned from a Pilot Program recently conducted at Halyard Health, and will evaluate the efficiency and consequences of this program for both the industry and regulatory bodies (Round table with Industry Participation)

 

Please contact Datalynx for additional Information on the topic

www.datalynx.com

 

Click here to register for the event:

https://lnkd.in/gMMqiHK

The GeorgiaBio Event on Quality Management System and MDSAP

08/17/2017

The GeorgiaBio Event on Quality Management System and MDSAP: A global approach to quality systems, auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.

The goal of the Medical Device Single Audit Program (MDSAP) is to provide for more effective, efficient and less burdensome regulatory oversight of the quality management systems of medical device manufacturers. The implementation of the MDSAP is intended to allow for a single audit to satisfy the regulatory requirements of the participants.

Industry Leaders from Halyard Health and Datalynx US CEO Manoj Karamchandani will discuss their view points and lessons learned from a Pilot Program recently conducted at Halyard Health, and will evaluate the efficiency and consequences of this program for both the industry and regulatory bodies (Round table with Industry Participation)

 

Please contact Datalynx for additional Information on the topic

www.datalynx.com

 

Click here to register for the event:

https://lnkd.in/gMMqiHK

TM Forum Live! 2017 Making Digital Transformation real!

03/27/2017

Digital Business is introducing new business models that are dramatically transforming CSPs and enterprises in unexpected ways. But where are you on your digital journey and what’s your role?
With an emphasis on ‘making it real’ TM Forum Live! 2017 provides you with impartial, actionable advice and the practical next steps you’ll need to navigate and manage this new environment and the complicated digital ecosystems which now exist.
The event will take place at Acropolis, Nice.
 
Datalynx is exhibiting their Advanced Analytics solution QUBIDA and we would be delighted to meet with you there.
For more information and to register, visit the TM Forum Live!2017 website.
 
Let us meet at TM Forum Live!


TM Forum Live
Where: Acropolis, Nice, France
When: 15-18 May 2017
Stand no: 222
Book a meeting for TM Forum Live!

Datalynx becomes Official IAPP Training Partner for Switzerland

03/21/2017

Datalynx becomes Official IAPP Training Partner for Switzerland

Bolivar Pereira (Corporate Alliance Consultant, IAPP), Paul Jordan (Managing Director, IAPP Europe), Noel Fitzgerald (Data Privacy Manager, Datalynx) and Scott Colati (Business Development Manager, IAPP) at the IAPP Europe Data Protection Intensive 2017 in London this week following the signing of the Training Partner agreement.

Datalynx will be providing classroom-based training classes in Switzerland for the following IAPP Certification programs:

  • Certified Information Privacy Professional Europe (CIPP/E)
    The CIPP/E encompasses pan-European and national data protection laws, key privacy terminology and practical concepts concerning the protection of personal data and trans-border data flows.
  • Certified Information Privacy Manager (CIPM)
    Make a difference in your organization and in your career. The CIPM designation says that you’re a leader in privacy program administration and that you've got the goods to establish, maintain and manage a privacy program across all stages of its lifecycle.
  • Certified Information Privacy Technologist (CIPT)
    The CIPT is the first and only certification of its kind worldwide. It was launched by the IAPP in 2014 to meet the growing need that only tech pros can fill—securing data privacy at all stages of IT product and service lifecycles.

The first training classes will take place in May 2017 in Basel - please contact privacytraining@datalynx.ch for further details.

This will be the first time that classroom based training classes for these IAPP Certification programs will be available in Switzerland.

IAPP KnowledgeNet Basel/Zürich - sponsored by Datalynx

11/08/2016

IAPP KnowledgeNet Basel/Zürich - sponsored by Datalynx

Data Breach: Risks - Mitigation - Handling

Around 30 people from a multitude of business backgrounds gathered at the Hotel Bildungszentrum in Basel to participate in this Data Security event. The morning opened with a look into the world of Cyber threats. With a demonstration by Wizlynx; Andreas Crisante (Senior Cyber threat intelligence advisor) and Christian Fichera (Senior IT security Analyst) proved how easy accessing confidential information can be. While the attacks they demonstrated were shockingly simple and potentially devastating they made it clear that the biggest threats to businesses rarely come from opportunistic ‘script kiddies’. Instead, the biggest threat for cyber-attacks come from groups involved in organized crime, those in the business of selling personal and corporate data. Stefan Keller (Senior Expert in Information Security and IT Privacy Governance at F. Hoffmann-La Roche) then explained exactly how vast the area of Data security is, cyber-attacks are only a portion of the problem. According to the statistics presented, it is clear that no sector is safe from Data breaches, and cyber incidents aren't the leading cause. As usual, human error seems to be the biggest cause for data breaches. Whether malicious or accidental, we as employees are the key to how safe company data is. Stefan Keller presented graphs sourced from ICO and, as seen below, the most common identified data breach was due to sending data to an incorrect recipient.

Heribert Grab (CIPP/E, CIPM, CIPT, FIP, senior Data Privacy Manager at Siemens) then spoke to us about how these risks can be mitigated on a management level. The General Data Protection Regulation (GDPR) is a regulation that aims to strengthen and unify data protection within the European Union. While Switzerland does not fall under these regulations, the information can be used to help guide management in structuring their organization. Heribert Grab also introduced us to the Nymity Privacy Management Accountability Framework and explained how this methodology can be adapted, prioritized and applied to your company in order to mitigate the majority of data protection concerns. He made it clear - when it comes to data protection, companies need to take a top down approach. Senior Management and Stakeholders need to be the driving force behind data security and need to be accountable for the outcome. Monika Josi (Head Global security consulting AXAS AG, Vice President International Development CyAN) reinforced Heribert Grabs points and focused on the need for collaboration between departments when addressing security concerns. Silos need to be removed in order to work cross functionally and effectively secure and protect data.

So what does this mean for you?

As Andreas Crisante stated "the damage becomes bigger if the incident is not handled correctly" - we all need to be aware of ways we contribute to the problem and understand how we can change our behaviors. As with most things, education is key.

If you need expert advice on Data Security and what it means for your company, please contact us!

IAPP KnowledgeNet on Nov 2nd, 2016 is hosted by Datalynx

11/01/2016

Datalynx is delighted to sponsor the following IAPP KnowledgeNet event:

Data Breach: Risk – Mitigation - Handling

Please join us at the upcoming KnowledgeNet and hear from a panel of experts about internal and external cyber security threats, major risks about data breaches and GDPR accountability and governance.

Date and Time:
Wednesday, 2 November 2016
8.30 – 12.00 AM including networking breakfast

Location:
Hotel Bildungszentrum 21
Missionsstr. 21
CH-4055 Basel

To register please go to: IAPP Events

Scroll down and click on: "Basel/Zurich KnowledgeNet: 2 November 2016" and follow the instructions there.

Guests and non-members are welcome to attend a KnowledgeNet meeting as space allows. They should register through the above link and will be required to create an account and log in prior to registering.