One Day Virtual Seminar Laboratory Inspection and Auditing


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$1299


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Quality auditing of pharmaceutical quality control laboratories is an important activity for those performing due diligence or monitoring the performance of a sub-contractor. Besides covering GMP regulations affecting pharmaceutical quality control, this one-day course is designed to provide the non-specialist with the necessary knowledge to understand the quality significance and risk associated with different analytical operations.

By the end of the course, attendees will be able to:

  • Identify non-conformance to cGMP regulations in analytical operations
  • Understand the key steps in the analytical process
  • Recognize commonly-used analytical techniques and instruments
  • Appreciate the significance of pharmacopeias in analytical operations
  • Understand the requirements for controlling reference standards, reagents and important consumables
  • Appreciate the importance of GMP controls over-analytical method suitability (validation, verification and transfer)
  • Classify analytical instruments according to the quality risk and understand the qualification requirements for each class
  • Understand current expectations for data integrity controls, including electronic data systems
  • Identify non-conformances in the control of stability studies
  • Appreciate the regulatory requirements for reference and retention samples

Learning Objectives:

  • US and EU GMPs relating to quality control operations
  • Appropriate GMP controls at each step in the analytical process
  • Information provided by different analytical techniques
  • Pharmacopeias – contents, structure and regulatory significance
  • Significance of ICH guidance
  • Quality requirements for reference standards and reagents
  • What are critical consumables and how should they be controlled?
  • Control of analytical methods over their lifecycle
  • Appropriate qualification of analytical instruments
  • Data integrity – current expectations
  • Control of stability studies
  • Requirements for reference and retention samples

Who Will Benefit:

  • GMP auditors
  • Quality assurance professionals
  • Laboratory managers
  • Quality management
DAY 01(10:00 AM - 5:00 PM EDT)
  • 10:00 AM -11:00 AM
      GMP regulations for quality control operations
      • US 21 CFR 211, 21 CFR 11
      • Key EU GMP chapters and annexes
      GMP controls over the analytical process
      • Sampling
      • Sample preparation and analysis
      • Results calculation and reporting
  • 11:00 AM -11:15 AM Break
  • 11:15 AM -1:15 PM
      Commonly-used analytical techniques
      • Wet chemical methods
      • Instrumental methods
      Pharmacopeias and ICH
      • Regulatory status
      • Contents/topics
      Control of standards, reagents, and consumables
      • Reference standards types/acceptability
      • Control of reagents
      • Critical consumables (e.g. chromatography columns)
  • 1:15 PM -1:45 PM Lunch
  • 1:45 PM -3:15 PM
      Lifecycle management of analytical methods
      • Development
      • Validation
      • Transfer
      • Verification of compendial methods
      • System suitability tests
      • Post-approval changes
      Analytical instrument qualification
      • Classification of analytical instruments
      • Risk-based qualification
  • 3:15 PM - 3:30 PM Break
  • 3:30 PM - 4:30 PM
      Data integrity
      • Overview of regulatory guidance
      • Data governance policy
      • Control of electronic data systems
      Stability studies
      • Storage conditions
      • Managing excursions
      • Requirements for reference and retention samples
  • 4:30 PM - 5:00 PM Final questions, feedback and close
Seminar (Price/Register)
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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  2. Fill this form with attendee details & payment details
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Pay your check issued from the payee to "Redstone Learning Inc." (Our Parent Company) and mail the check to –
Compliance.world (Redstone Learning Inc.)
1180 Avenue of the Americas,
8th Floor, New York,
NY 10036

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