Combination Product Device Supplier Management Training

Speaker

Instructor: John E Lincoln
Product ID: 706876
Training Level: Intermediate to Advanced

Location
  • 28
  • March 2023
    Tuesday
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 90 Min
The U.S. FDA continues to increase its requirements for tighter control and management of vendors / suppliers / outsourcing. Combination products doubles the problems. And Covid 19 has compounded supply chain issues.
LIVE ONLINE TRAINING

March 28, Tuesday 10:00 AM PDT | 01:00 PM EDT
Duration: 90 Min

 

$199.00
One Dial-in One Attendee

$999.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

$349.00

$399.00

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days after completion of Live training
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Why Should You Attend:

Recent FDA statements and actions indicate the past ways of managing a company's supply chain / outsourcing are not acceptable. The U.S. FDA has opened eleven of it's own branches in Mainland China, India, and other major areas of the world to train their local counterparts and to better address and audit regulatory compliance of suppliers of medical products and components destined for the U.S. CGMP compliance cannot be passed on to suppliers. Suppliers thenselves must meet specific CGMP requirements. Proof for "better science" is also a new expectation and is already having its effect on COAs and COCs. Combination products serve to compound the problems. Don't be caught of guard by these major shifts in emphasis. Refine supplier management and audits to match the growing FDA requirements.

There has been a major shift in the emphasis of U.S. FDA requirements for supplier CGMP compliance. The FDA has implemented major global initiatives. Companies are required to tightly manage their entire supply chain. The infrastructure behind the COA / COC is being challenged. Such changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. The Agency is reacting to increasing negative publicity due to major publicized product failures / recalls / and notable recent product shortages, leading to public concern over insufficient oversight of the entire medical product supply chain, including global outsourcing. Of both raw materials, components, as well as services. Combination product add further complexity. "Better science" requirement impacts suppliers as well. All this is affecting the Agency's approach to inspectioina / audits and their expectations for companies. These areas of change will be evaluated to see how to better prepare for and address supplier chain management and vendor audits.

Areas Covered in the Webinar:

  • The Globalization of the Supply Chain and What That Means
  • Combination products and added supplier complexity
  • Avoid complacency from past "good" FDA / ISO audits
  • Supplier Trending and Ranking Models
  • Mandated Supplier Controls; Change Controls
  • COAs / COCs
  • Consequences of the "death" of JIT
  • The Tiered Risk-Based Audit Approach

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies in evaluating their existing supply chain control / ccompliance and vendor audits in light of changing FDA's CGMP supplier management requirements and enforcement. Once recognizing the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance. This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Neutraceutical, Biologics and Combination products fields. The employees who will benefit include:

  • Senior management
  • R&D
  • Regulatory Affairs
  • Quality Assurance
  • Purchasing
  • Production
  • Engineering
  • All personnel involved in a U.S. FDA-regulated environment. Especially those involved in the establishment, monitoring, and review / audits of outsourced parts and services used in regulated medical products.
Instructor Profile:
John E Lincoln

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

Follow us :

 

 

Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2021 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method