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News & Events

Webinar: ICH E6 (R2) Risk-Based Requirements: Beyond Just Risk Planning to Actual Success in Risk Review and Control

February 13, 2019 | 11:00am - 12:00pm EST
Learn leading practices for a comprehensive risk-based approach to implementing and living in an ongoing, risk-based culture through the minimization of active, high resource-consuming issues.

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Webinar: Confident Risk-Based Inspection Readiness: An Achievable New Year’s Resolution

January 29, 2019 | 10:30am - 11:30am EST
This webinar will review practical steps to reaching and maintaining a confident level of risk-based inspection readiness using vendor oversight as an area of focus.

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ExL’s 8th Trial Master File Summit

January 22-24, 2019  |  Hilton Orlando Lake Buena Vista  |  Orlando, FL Learn more >> 15% off standard pricing rates using Discount Code AVOCAVIP   Join Avoca for the following session: Thursday, January 24 – 9:10am  |  Main Conference Day Two [Panel] Prepare for a TMF Inspection With a Quality Management System Manifest prioritization drivers […]

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ExL’s 8th CROWN Congress

January 22-24, 2019  |  Hilton Orlando Lake Buena Vista  |  Orlando, FL CROWN provides a comprehensive education on the latest strategies, trends, tools, and technologies for optimizing clinical trials and enables you to make the connections necessary to streamline operations and advance. In 2019, the 8th Crown Congress will expand on last years conference by […]

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Webinar: Quality Tolerance Limits (QTLs) as required by ICH E6 (R2): Definitions and requirements for “fit-for-purpose” compliance

January 9, 2019 | 11:00am – 12:00pm EST
Presented by Steve Whittaker and Jay Turpen, this interactive webinar will clarify terminology, including metrics, performance indicators, and tolerance limits.

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Article: Taking Control Of Clinical Quality Tolerance Limits In Clinical Trials

By Steve Whittaker, Senior Consultant, The Avoca Group ClinicalLeader.com – January 8, 2019   The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) regulations have created a buzz within the industry regarding newly required expectations for quality tolerance limits (QTLs) when conducting good clinical practice (GCP) clinical trials. QTLs […]

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Article: Embracing the present and owning the future in clinical trial execution

By Crissy MacDonald, PhD, Executive Director, Client Delivery, The Avoca Group Outsourcing-Pharma.com – December 13, 2018   2018 was a pivotal year for the pharmaceutical industry and the execution of clinical trials. In November 2016, for the first time in more than 20 years, the ICH E6 Good Clinical Practice (GCP) Guideline was amended, and […]

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Quality Tolerance Limits as Required by ICH E6(R2): Definitions and Requirements for “Fit-For-Purpose” Compliance, New Webinar Hosted by Xtalks

TORONTO, December 13, 2018 (Newswire.com) – Expectations for quality tolerance limits when conducting Good Clinical Practice (GCP) clinical trials in accordance with ICH E6(R2) have generated a buzz in the industry. Quality tolerance limits have historically been required for Good Manufacturing Practice (GMP) activities, inferring limits by which significant actions must be taken to ensure the manufactured product achieves quality and usability limits. With regulators now […]

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