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Ref : 29606
Event :FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

Date :Thursday June 13th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.

Objectives

  • Understanding the FDA’s requirements for medical device supplier assessment and approvals
  • Learning “who” are considered to be suppliers
  • Knowing how to structure a supplier quality agreement
  • Selecting the potential methods for evaluating and assessing suppliers

Program

  • 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

Speakers

Danielle DeLucy

Danielle DeLucy
Owner, ASA Training and Consulting, LLC

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy has been in the industry for 15 years serving in numerous quality management roles, such as the director of product quality, the oversight of sterility assurance practices and provided QA oversight of numerous filling and packaging operations.

Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the quality management arena while increasing her responsibility. She has helped lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

 
 

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Location

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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Details

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More Management
fda supplier management training, supplier quality management, supplier quality agreement, supplier selection, supplier audits
Professionals, Quality Assurance/Quality Control Directors, Managers, And Specialists Regulatory Affairs/Regulatory Compliance Directors, And Specialists Purchasing/Materials Management Directors, And Specialists Engineering/Development Directors, And Specialists Document Control Managers and Specialists
10 -- --
English

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