Effective Strategies to Manage Validation In Conformance With The Pharmaceutical Quality System

Thursday, Oct 26, 2017 at 1:00 PM to 2:30 PM EST

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Thursday, Oct 26, 2017 at 1:00 PM to 2:30 PM EST

Event Description: 

     ICH Q10, The Pharmaceutical Quality System, which was released to the international pharmaceutical industry in 2008, includes the concept of the product lifecycle. Since that time, the lifecycle approach has been applied to all aspects of pharmaceutical products and processes. ICH Q8, Pharmaceutical Development, and ICH Q9, Quality Risk Management, are closely integrated with ICH Q10. In 2011, the FDA issued its Guidance for Industry, Process Validation: General Principles and Practices. This guidance integrates quality system concepts from ICH Q8, ICH Q9 and ICH Q10 including lifecycle and identifies the three stages of the process validation lifecycle. The Europeans followed with a similar guidance for process validation including the lifecycle concept. This has now been incorporated into the revised Annex 15: Qualification and Validation of the EU GMPs. Worldwide, the pharmaceutical community is approaching process validation as a process control tool that is applied to pharmaceutical production processes throughout the life of the process and the product. It is now a challenge for the process validation team to integrate a lifecycle approach into the development and validation of new processes and the verification of the validation of old processes.

Event URL: http://bit.ly/2yM9pB9

Speaker: Joseph N Wolfe

Compliance Training Panel: Compliance Training Panel has been established by professionals in the field of quality, compliance auditing and health care, education finance with an objective to create an ecosystem that will deliver quality trainings on compliance of various regulatory, and legal requirements. Our focus is to create a word class platform through which our clients can discuss and post their queries on regulatory compliance, quality, new technological developments and industry best practices with industry experts and to gain related information. CTP’s core competence is to identify, assess, and provide quality trainings by involving speakers and trainers with extensive experience in the respective fields. In today’s world, organizations are operating in an increasingly more complex and demanding risk environment. Our training programs are designed to ensure that our participants will be better equipped to understand the requirements, implement and improve compliance. Our training services are built around knowledge and understanding of the requirements and designed for Practitioners and Managers/Executives involved in quality, compliance, Operations and maintenance. The trainings programs are structured to help our participants develop a deep understanding on the requirements and standards.

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