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FDA Compliant QC and QA Practices – Creating a Perfect, Audit-Ready QMS

This course equips pharmaceutical quality professionals to strengthen QC and QA coordination, reduce inspection exposure, and build a QMS that consistently supports GMP compliance, audit readiness, and product quality expectations across manufacturing operations. This Course is designed for professionals responsible for pharmaceutical manufacturing quality systems, compliance oversight, documentation, and audit preparation.

REGISTER FOR THE COURSE

US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Joy Mcelroy
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF2557
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Pharmaceutical manufacturers rely on Quality Control and Quality Assurance functions to ensure products meet safety, efficacy, identity, and intended-use expectations. These responsibilities extend beyond laboratory testing and documentation review, requiring clear operational boundaries, coordinated oversight, and consistent GMP application throughout manufacturing activities. Regulatory agencies expect both functions to operate within a structured Quality Management System that supports reliable decision-making, procedural control, and product quality. Weaknesses in these areas can increase inspection findings, disrupt operations, and raise concerns regarding compliance practices.


Effective quality systems require alignment between procedures, training, auditing practices, and day-to-day execution. This program clarifies FDA expectations for QC and QA operations, identifies common compliance gaps associated with inspection observations, and explains the elements required for an audit-ready QMS. Attention is also given to applying GMP principles within routine quality activities so organizations can maintain consistent oversight and support sustainable manufacturing performance.

  • Strengthen QC and QA Accountability:

    Clear separation and coordination of Quality Control and Quality Assurance responsibilities reduces operational confusion during inspections and internal reviews. Participants gain practical understanding of FDA expectations, batch record oversight, procedural consistency, and GMP application within daily quality activities. These capabilities support more reliable manufacturing decisions and reduce exposure to recurring compliance observations.

  • Build a QMS Ready for Regulatory Scrutiny:

    A well-structured Quality Management System demonstrates organizational control over product quality, procedural compliance, and audit preparedness. This course explains the operational components needed to maintain inspection readiness, support consistent documentation practices, and reinforce communication between QC and QA functions. Facilities facing increasing regulatory attention benefit from stronger system accountability and clearer quality responsibilities.

Key Areas Covered

  • FDA expectations for Quality Control and Quality Assurance operations
  • Functional differences and operational coordination between QC and QA units
  • Common compliance deficiencies associated with FDA 483 observations
  • Core requirements for establishing and maintaining an effective Quality Management System
  • Application of GMP principles within Quality Control and Quality Assurance activities
  • Procedures and operational practices supporting audit-ready quality systems
  • Responsibilities of Quality Control in ensuring product identity, safety, and defect prevention
  • Methods for maintaining procedural consistency and regulatory readiness across quality operations

Who Must Attend

  • Quality Control Departments
  • Quality Assurance Departments
  • Research and Development Teams
  • Regulatory Affairs Departments
  • Management and Supervisory Team
  • Validation Departments

Quality training, expert insights, and answers that matter. Know your Expert

JOY MCELROY

Joy McElroy has more than 25 years of pharmaceutical and biotech industry experience spanning Quality Control, Quality Assurance, GMP compliance auditing, equipment qualification, cleaning validation, and technical writing. Her background includes laboratory supervision, batch record review, GMP training, and validation protocol execution for companies including Wyeth Lederle, Merck, Catalent, and Novartis. She also provides GMP, audit preparation, SOP writing, and compliance training through her consultancy, McElroy Training and Consultancy, LLC.

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Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

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2. Your Course Hub
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3. Access course materials
The presentation handout and other materials can be downloaded inside the Course Player. You could use Discussion feature there to ask your questions.

4. Watch The Streaming and Complete your Course
The course playback will be available on the same course page. You could pause and continue or you can revisit important sections.
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Complete the course and your certificate is unlocked automatically in your learning history.

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Our students love us ❤️

“Presenter kept the content focused on actual GMP and inspection concerns instead of theory.”


Specialist, Quality Operations

“Discussion around audit readiness and QMS expectations was practical and easy to apply internally.”


Supervisory Team

“Good breakdown of QC and QA responsibilities. It clarified where common compliance issues usually begin.”


Manager, Quality Assurance

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