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2 Day Workshop - Enhanced Approach for Analytical Procedures

Course Objectives

This 2-day workshop demonstrates the enhanced approach for analytical procedures from development to continual monitoring of routine performance and how it can result in more robust procedures. The principles can also be applied to verification and transfer of procedures.

A fun, hands on practical component using a Statapult has been designed to demonstrate the enhanced approach including setting a target profile, investigating and controlling variables for the process and qualifying the process against the predetermined target.

Case studies are included for development of a new procedure and verification of a compendial monograph procedure.

Although the material is based on HPLC for small molecules, the principles taught and the practical session, may also be applied to analytical procedures for large molecules.
This workshop is based on ICH Q8, Q9, Q10and Q14 (a working group has been assigned to write this new guideline)

The workshop emphasizes practical issues such as:

  • Setting a predetermined target profile for procedure performance
  • Method understanding
  • Development of the Analytical Control strategy
  • Using Risk Assessment Strategies
  • The importance of knowledge transfer and good communication
  • Exploring and controlling variables of analytical methods
  • Improvement of analytical procedure performance

It will deliver the tools to enable you to:

  • Be up to date with best practices and guidelines for analytical procedures
  • Share and consider problems associated with analytical procedures
  • Define a target profile
  • Apply the enhanced approach to development of new procedures
  • Apply the enhanced approach to existing procedures for successful Verification and Transfer
  • Develop and optimize a robust control strategy leading to more robust analytical procedures
  • Understand how to monitor analytical procedures for acceptable performance throughout its lifecycle.

Who should attend?

Chemists or management involved in the testing of pharmaceutical products

Managers, Supervisors, Laboratory Analysts and Associates involved in the development, validation, transfer, testing or review of analytical procedures in the Pharmaceutical and related industries with daily responsibilities in the following areas:

Analytical Development Laboratory
Quality Control Laboratory
Contract Laboratory
Training
Quality Assurance

What’s included with the workshop? 

Each participant will receive:

  • A certificate of attendance upon completion of the workshop.
  • Printed materials and handouts relating to the workshop
  • Lunch and light refreshments each day.

Course Leader

Pauline McGregor, PhD. CChem MRSC has over 30 years experience in the pharmaceutical industry. She been involved in the development of this topic since 2010 and has been an active member of the USP expert panel for Validation, Verification and Transfer of Analytical Procedures.

Course runs 9:00 am - 4:30 pm on both days.

Course Properties

Course Date Mar-04, 2019 9:00 am
Course End Date Mar-05, 2019 4:30 pm
Registration Start Date Feb 01, 2019
Cut off date Feb 18, 2019
Individual Price $1,150.00
Course Leader Pauline McGregor, P.h.D.CChem MRSC
Location Radisson Suite Hotel Toronto Airport
This course is currently not available:  Notify Me When a Course is Scheduled
$1,150.00 12

Recommendations

  • Pauline is keen and hardworking, she loves her sciences and passionate about what she does. I so much enjoyed working with her, she has provided great insight on many technical and scientific issues related to analytical method development and analytical method validation. Her most important quality is her patience and perseverance and of course, fun to work with
  • Contracted Pauline to assess analytical methods validation, and to subsequently create a 'gap' report - and then to work at 'fixing' the gap. Pauline was excellent in her attention to detail, and her thorough knowledge of what was needed. She also worked on several projects after that one - always with the same high standards and commitment to provide value to the client. I heartily endorse her work.
  • Pauline is an excellent professional in the life science business. She did a great job as project manager in analytical development and validation at SGS Life Science Services. She was appreciated by her colleagues and her customers.
  • Pauline's ability to understand and integrate the scientific challenges of industry, with government and academia are unsurpassed. I am so confident with her ability to deliver meaningful yet pragmatic leadership as it applies to the pharmaceutical industry that I have recommended her to numerous prominent companies who have subsequently hired her and been extremely happy with the results she is able to deliver.