Follow FDA-Compliant QA/QC Practices—and Create an Audit-Ready QMS

Event Information
0 Days
Left To Register
Product Format
Live Webinar
Presenter(s)
Conference Date
Add to my calendar   Wed, Apr 25, 2018
Aired Time
1 pm ET | 12 pm CT | 11 am MT | 10 am PT
Length
60 minutes
Product Description

QA v QC: Learn the difference—plus prep for an FDA audit


One of the top trends for the pharmaceutical industry in 2018 is quality oversight. Do you know the difference between quality assurance (QA) and quality control (QC)? And is your quality management system (QMS) up to snuff should FDA auditors come knocking?

As you know, your manufacturing processes—whether related to pharma, biotech, or medical devices—come under strict scrutiny from the U.S. Food and Drug Administration (FDA) as to quality. Your company-specific requirements must be spelled out in your quality manual and underlie your entire quality management system (QMS). Still, many companies do not have clearly defined or differentiated QC and QA practices—and FDA audits frequently uncover non-compliant QC and QA practices.

Don’t risk your ability to gain speedy market approval for products. Join Joy McElroy, quality expert in the biotech and pharmaceutical industries, for this in-depth session on how to distinguish between QA and QC—both in terms of quality practices and personnel. During the presentation, you will learn how to effectively establish two distinct rigorous programs to prevent compliance violations and delays in marketing your product.

McElroy will clue you in to the best procedural implementations for top-quality QA and QC functions. She will also identify the common QA- and QC-related findings from an FDA audit—and how to address the agency’s findings.

Session Highlights

After attending this program, you will be able to answer these key questions:

  • What is QC versus QA?
  • What is quality management, and how do you establish an QMS?
  • Why does the FDA regulate manufacturing process quality the way it does?
  • What are your key quality compliance responsibilities?
  • What compliance errors are most common in an FDA audit?
  • What steps to take—and what to avoid—when organizing QC and QA efforts?
  • How must you document your quality metrics and practices?
  • How to survive—and thrive—under FDA scrutiny?

Who Should Attend

This compliance information session is designed specifically for professionals in the pharmaceutical, biotech, and medical device manufacturing industries, including:

  • Department directors and managers
  • Regulatory and compliance personnel
  • Quality assurance and quality control staff
  • Project managers

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Joy McElroy

Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing environmental monitoring and sterility testing after earning a degree in zoology at North Carolina State University. She moved into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.  In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and...   More Info
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