Tag Archives: Conference

FDAnews Announces Device Supplier Controls Virtual Conference, Feb. 26


Falls Church, VA (PRWEB) February 07, 2014

Device Supplier Controls

Does the FDA’s Next 483 Have Your Name on It?

**FDAnews Virtual Conference**

Feb. 26, 2014 — 10:00 a.m. – 4:00 p.m. EST

http://www.fdanews.com/DeviceSupplierVC

The medical device industry is struggling, with a forecast of single-digit overall growth for 2014.

To cope with that, devicemakers are outsourcing more and more of their critical operations and materials, trying to wring out costs and improve their profitability.

The unintended consequence?

A much, much greater risk of supplier control violations. After all, the more suppliers you have, the more opportunities you give the FDA to find fault with your operations.

Some devicemakers say they have as many as 400 outsourced contract manufacturers and suppliers.

It’s no surprise, then, that it has become increasingly difficult to manage them and be sure that all raw materials, finished products and services meet the devicemaker’s required specifications as well as comply with FDA regulations.

This FDAnews virtual conference is designed especially to take the headaches out of working with an ever increasing number of suppliers. Sign up to attend and take home practical tools and invaluable tips that will help devicemakers be more confident that their outsourced work will not result in a Form 483 or warning letter.

There’s simply so much that can go wrong when outsourcing. On Wednesday, Feb. 26, a panel of experts will spend the day, identifying and discussing such key problem areas as:


    What non-compliance issues most frequently trigger an audit

    Understanding global supplier monitoring requirements: Can an FDA-centric program fulfill international requirements?

    Best practices for prioritizing a supplier control approach that will work for large or small companies

    Managing supplier controls over the long haul to create good business relationships and assure FDA compliance

    What motivates a supplier to do business

    How to test SOPs against the most commonly cited sections of 21 CFR 820.50

    Verifying that supplier dossiers contain the records FDA inspectors want to see

    How to identify the warning letters that include hidden FDA requirements that tripped other companies up

    Critical documents to have at the ready to print out and produce the moment the FDA inspector demands them

Register Today

Device Supplier Controls is a must-attend event for colleagues from the manufacturing floor to materials management, and the legal counsel’s office to the executive suite.

    Quality assurance/quality control
    Operations
    Manufacturing
    Materials management
    Purchasing
    Packaging and labeling
    Plant engineering
    In-bound testing and certification
    Regulatory affairs
    Legal counsel

Attendee Resource Toolkit — Registered attendees will also receive the following resources to help them better manage their supplier control program:

    Slide decks from all five presentations
    FDA’s 21 CFR 820.50 regulation
    A compilation of recent FDAnews articles related to supplier control problems at medical device manufacturers
    New Therapeutic Goods Administration (TGA, Australia) guidance on supplier qualification for raw materials, drugmakers
    GHTF/SG3/N17:2008 Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained From Suppliers

Meet the Faculty

John Avellanet, Principal Consultant, Cerulean Associates

David Parkin, Supplier Development Manager, Boston Scientific

Jackie Torfin, Vice President of Quality, Heraeus Medical Components

Mike Heyl, Partner, Hogan Lovell (invited)

William MacFarland, Director, Division of Enforcement, Office of Compliance, CDRH, FDA(invited)

Register now

Conference Details

Device Supplier Controls

Does the FDA’s Next 483 Have Your Name on It?

**FDAnews Virtual Conference**

Feb. 26, 2014 — 10:00 a.m. – 4:00 p.m. EST

http://www.fdanews.com/DeviceSupplierVC

Tuition

$ 1,297 per site — includes virtual conference registration and audio cds and transcripts

Easy Ways to Register

Online:     http://www.fdanews.com/DeviceSupplierVC

By phone: 888-838-5578 or 703-538-7600

About FDAnews

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.







Center for Connected Health, Partners HealthCare to Speak at Pharmica Consultings Pharma 3.0 The Digital Medicine Era Conference


Conshohocken, PA (PRWEB) February 18, 2014

The pharmaceutical industry is at a crossroads. The era of writing one prescription after another is over. Patients, advocacy groups, payers, government, and others are asking for better outcomes. Enter digital medicine. To help pharmaceutical companies better understand how digital medicine will redefine the pharmaceutical business model, Pharmica will host its “Pharma 3.0 – The Digital Medicine Era” conference in Conshohocken, PA on April 30th & May 1st, 2014.

“Joseph C. Kvedar is the Founder and Director of the Center for Connected Health, Partners HealthCare and is creating a new model of healthcare delivery, developing innovative strategies to move care from the hospital or doctor’s office into the day-to-day lives of patients,” said Matt Hendricks, Partner with Pharmica Consulting.

“Dr. Kvedar will discuss how mobile health offers can improve the way patients manage their health. The use of smart phones as a data upload/home hub device, or as a way to engage the consumer around health content is become more and more popular. They can be used to display health-related information at just the right moment in just the right context, and the built-in cameras can capture relevant health information. Transitioning patients to a new therapeutic can be difficult, Dr. Kvedar will present three key strategies to improve adherence and make health addictive.”

Those interested in learning more about Pharmica Consulting and upcoming forums or service offerings can visit http://www.pharmicaconsulting.com/services/. To request additional information, please contact Greg Cohee at 215-579-1650 or Matt Kiernan at 610-945-4364.

About Pharmica Consulting:

Pharmica Consulting, one of the Life sciences Industry leading consulting firms, provides a variety of offerings designed to help pharmaceutical and biotech clients achieve true operational excellence. Consultants at Pharmica invest the time needed to truly understand a client’s specific challenges and tailor solutions to help them create a more profitable business environment. Pharmica Consulting knows how to build effective strategies – and deliver against those strategies as promised.







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