RAPS

ICH Proposes Two New Guidelines

The International Council for Harmonisation (ICH) has announced two new guidelines, with one (M9) providing recommendations to support the biopharmaceutics classification of medicinal products, while ...
RAPS

FDA Consults on ICH Safety Data, Bioanalytical Method Validation Guidelines

The US Food and Drug Administration (FDA) on Wednesday issued two draft International Council for Harmonisation (ICH) guidelines covering safety data collection and bioanalytical method validation for ...
Labroots

ICH Q2 Validation of Analytical Procedures for Pharmaceutical Total Organic Carbon Analyzers

The tripartite International Conference on Harmonisation (ICH) Q2 guide on validation of analytical procedures is not new, but it can give very good advice when validating laboratory Total Organic ...
Yahoo Finance

3hr Virtual Seminar: Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH

Dublin, Feb. 27, 2025 (GLOBE NEWSWIRE) -- The "3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH" training has been ...
Labroots

WEBINAR: ICH Q2: Validation of on-line TOC analysers

The work of ICH has significance for pharmaceutical manufacturers globally. This webinar discusses the key validation characteristics to be considered for quality-critical applications according to ...
PharmTech

Evolution of Analytical Procedure Validation Concepts: Part II– Incorporation of Science and Risk-based Principles in ICH Q14 and Q2(R2) Guidelines

No additional expectations or mandated requirements are expected in Q14, Q2(R2) and USP <1220>. The minimal approach can still be used. Q14 and Q2(R2) are consistent with the principles described in ...
Business Wire

Validation, Verification and Transfer of Analytical Methods: Understanding and Implementing Guidelines from FDA/EMA, USP and ICH - San Francisco, CA, United States - December ...

DUBLIN--(BUSINESS WIRE)--The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added to Research ...
technologynetworks

Applying a Lifecycle Approach to Your Analytical Procedures and Method Validation Programs

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...
Yahoo Finance

Biopharmaceutical Manufacturing Process Validation: Understand FDA Guidance and EU Guidelines (Nov 17th - Nov 18th, 2025)

Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Biopharmaceutical Manufacturing Process Validation (Nov 17th - Nov 18th, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...
PharmiWeb

Two Day Virtual Process Validation Guidance Requirements Course: FDA and EU Annex 15 Qualifications and Validation - March 31, 2022 April 1, 2022) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)" training has been added to ResearchAndMarkets.com's offering. The Process ...
Business Wire

Validation, Verification & Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added to ...