23. September 2020 - 12:30 till 20:30
United StatesPhiladelphiaTo Be Announced

Laboratory Inspection and Auditing (com) A, Philadelphia, Wednesday, 23. September 2020

Laboratory Inspection and Auditing

About this Event



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 pharmacopoeias 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 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

Seminar Fee Includes:


AM-PM Tea/Coffee

Seminar Material

USB with seminar presentation

Hard copy of presentation

Attendance Certificate

$100 Gift Cert for next seminar

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
  • Pharmacopoeias – 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(8:30 AM - 4:30 PM)

8:30 AM -8:59 AM Registration, Meet & greet

9:00 AM -10:00 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


Sample preparation and analysis

Results calculation and reporting

10:30 AM -10:45 AM Break

10:45 AM -12:00 NOON

Commonly-used analytical techniques

Wet chemical methods

Instrumental methods

Pharmacopoeias and ICH

Regulatory status


Control of standards, reagents and consumables

Reference standards types/acceptability

Control of reagents

Critical consumables (e.g. chromatography columns)

12:00 NOON -1:00 PM Lunch

1:00 PM -3:00 PM

Lifecycle managements of analytical methods




Verification of compendial methods

System suitability tests

Post-approval changes

Analytical instrument qualification

Classification of analytical instruments

Risk-based qualification

3:00 PM - 3:15 PM Break

3:15 PM - 4:15 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

4:15 PM - 4:30 PM Final questions, feedback and close


Mark Powell

Director, Mark Powell Scientific Limited

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.

"Please contact the community manager Marilyn (email ) below for:

- Multiple participant discounts

- Price quotations or visa invitation letters

- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)

- Event sponsorships


Service fees included in this listing.


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Wednesday, 23. September 2020, Philadelphia, Laboratory Inspection and Auditing (com) A

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