FDA Requirement for Quality Agreements with Vendors: Vendor Management Issues Resolved

Duration: 60 Minutes
It is the responsibility of a manufacturer to assure that all its suppliers are compliant with FDA's current requirements applicable to their operations. Supplier management starts with appropriate qualification, contracts, and quality agreements, and requires continuing quality assurance (QA) practices, including sampling, 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 The recently proposed FDA Draft Guidance on Quality Agreements describes the relationship between owners and contractors, and defines all the expectations for both parties when it comes to complying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 and GLP requirements. This webinar would 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 findings related to suppliers during audits will be discussed with potential remedies.
Vendor Management Contracts
Instructor: Mukesh Kumar
Product ID: 500668

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 the manufacturer to assure that all its suppliers are compliant with FDA's current GMP requirements. This webinar would describe FDA's expectations from manufactures and suppliers alike.

Why Should you Attend:
This webinar will review FDA's regulations related to suppliers in manufacture and testing of drugs, biologics and medical devices. Content and structure of SOPs for supplier qualification and quality agreements will be discussed. Common FDA audit findings will be discussed. The US regulations will be compared with those in the EU to identify common themes across different regulatory agencies and ways to comply.

Objectives of the Presentation:
The objectives of the presentation are to cover areas such as:
  • Regulatory requirements for supplier qualification
  • Responsibilities of manufactures and suppliers
  • Best practices for supplier selection, qualification and management
  • What are the FDA's expectation 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 can 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
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
View More