Two-day training course on validation, verification and transfer of virtual analytical methods: November 8-9, 2021 – ResearchAndMarkets.com

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DUBLIN – (COMMERCIAL THREAD) – The training “Training in validation, verification and transfer of analytical methods” has been added to ResearchAndMarkets.com offer.

Reliable analytical results are needed to make informed decisions about product quality and safety in the pharmaceutical industry.

In addition, these analytical data are required for regulatory submissions to support pharmaceutical product registrations. Therefore, meaningful experimental designs including system suitability parameters should be planned for the intended use of the procedure.

In this course, general guidelines for determining analytical characteristics for different types of validation procedures are highlighted for drug substance and drug product analysis. Factors to be considered in verifying pharmacy procedures will also be discussed.

In addition, different approaches for transferring the analytical procedure from one laboratory (handover) to other laboratories (reception) under different circumstances will be covered. Other topics related to obtaining reliable data will also be discussed. These topics include the qualification of analytical instruments as well as how to define, manage and monitor specifications.

Due to the global nature of the pharmaceutical industry, other quality topics on Regulatory Harmonization (ICH) and Pharmaceutical (USP) are also covered. These topics are valuable to scientists directly or indirectly involved in drug development and analysis. stability studies or regulatory / official submissions.

Learning objectives:

  • Drug approval process and regulatory requirements (private standards)

  • Pharmacopoeia and pharmacy approval process (public standards)

  • Pharmaceutical harmonization process

  • Chromatography System Suitability Requirements

  • Permitted adjustments of chromatographic system parameters

  • Analytical instrument qualifications including DQ, IQ, OQ, PQ

  • Validation of the analytical method

  • Verification of the analytical method

  • Analytical method transfer

  • Alternative to the official procedure and options

  • Life cycle of the analytical procedure

  • How to set specifications and how to handle out of specification (OOS) and out of trend (OOT) results

Main topics covered:

DAY 01 (9:00 a.m. – 4:00 p.m. EST)

9h00 – 10h00:

Review of seminar objectives, expectations and scope.

Drug approval process and regulatory requirements (FDA) (private standards)

Pharmacopoeia and Pharmacopoeia (USP) Approval Process (Public Standards)

10:00 am – 11:00 am:

Pharmaceutical harmonization process

Chromatography System Suitability Requirements

Permitted adjustments of chromatographic system parameters

11h00 – 12h00:

Qualifications in analytical instruments

Instrument categories

Qualification phases (DQ, IQ, OQ, PQ)

12h00 – 13h00: Lunch

13h00 – 14h00:

Validation of the analytical method (typical validation parameters)

Specificity

Precision / Accuracy

Linearity / range

LOD and LOQ

2:00 p.m. – 3:00 p.m .:

Verification of the analytical method

FDA and USP requirements

Factors to consider

3:00 p.m. – 4:00 p.m .:

Analytical method transfer

Different approaches

4:00 p.m. – 4:30 p.m.PM:

Summary and review

DAY 02 (9:00 a.m. – 12:00 p.m. EST)

9h00 – 10h00: Life cycle of the analytical procedure

10:00 am – 11:30 am:

Adjustment specifications FDA regulations and ICH directives (Q6A)

Out of specification (OOS)

Off Trend (OOT)

How to manage OOS and OOT?

11:30 am – 12:00 pm: Summary and assessment

For more information on this training, visit https://www.researchandmarkets.com/r/gz61rr


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