FDA's Expectations from Supplier Management for GMP: Quality Agreements and More

Speaker

Instructor: Mukesh Kumar
Product ID: 703483

Location
  • Duration: 90 Min
This webinar will review FDA’s regulations related to suppliers in manufacture of drugs, biologics and medical devices. It will discuss the current regulations, guidance documents and best practices for supplier management and enforceable quality agreement using case studies for a variety of scenarios. Common FDA audit findings will be discussed.
RECORDED TRAINING
Last Recorded Date: Dec-2015

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$399.00
1 USB is for usage in one location only. info CD/USB and Ref. material will be shipped within 15 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Why Should You Attend:

Suppliers form a critical element of the GMP compliance status of a manufacturer. Supplier could be used for pretty much any aspect of manufacturing such as raw material, components, packaging, shipping, and even finished product. It is the responsibility of a manufacturer to assure that all its suppliers are compliant with FDA’s current GMP requirements applicable to their operations. Supplier management starts with appropriate qualification, contracts, and quality agreements, and requires continuing quality assurance (QA) practices including sampling and testing, and supplier audits. FDA compliant quality systems require a vigorous supplier qualification process and robust quality agreements with all suppliers. The recently proposed FDA draft guidance on Quality Agreements describes the relationship between owners and contractors, and defines all the expectations for both parties when it comes to complying with GMP requirements.

This webinar will describe FDA’s expectations from manufactures and suppliers alike. Common FDA findings related to suppliers during GMP audits will be discussed with potential remedies. It will also discuss content and structure of SOPs for supplier qualification and quality agreements. The US regulations will be compared with those in the EU to identify common themes across different regulatory agencies and ways to comply.

Areas Covered in the Webinar:

  • Regulatory requirements for supplier qualification.
  • Responsibilities of manufactures and suppliers.
  • Best practices for supplier selection, qualification and management.
  • What are the FDA’s expectations in regards to Quality Agreements?
  • What is meant by the title owner, contractor, adulterated drug, and the term manufacturing within the guidance?
  • Best practices for a good quality agreement.
  • Supplier audits.
  • Documentation requirements and audit trails.

Who Will Benefit:

  • Managers of GMP or QSR compliant manufacturers of drug, biologics and medical devices.
  • Managers and QA personnel from Contract Manufacturing Organizations (CMOs).
  • Regulatory and quality professionals working for US companies that are considering the suppliers in non-US regions.
  • Suppliers in non-US regions looking to US-based clients.
  • QA/QC/Compliance/Regulatory affairs professionals.
  • Regulatory, compliance and quality professionals consulting with companies developing such products for the US market.
  • Business professionals looking to understand the risks and benefits of investing in such products.

Instructor Profile:

Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide.

Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affair professional by the Regulatory Affairs Professional Society, USA.

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