How to Adapt Your QMS to Address Significant Changes and Risks
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Are you ready to adapt your QMS to address significant changes and risks?
One of the main challenges that pharmaceutical and medical device companies face is ensuring that they have a robust Quality Management System that continually meets the requirements of all the regulations they must adhere to and keeps abreast of significant changes.
It can be any manner of change, such as:
• Changes in the business operations such as new product types, new commercial activities, and new supply chains
• New regulations and guidelines (ICH, ISO, CTR, NVR, MDR, Serialisation, etc.)
• Changes in personnel and facilities
Pharmaceutical companies need to recognize that their QMS is a holistic system and needs to be reviewed and amended as the company expands its products to new markets and introduces new regulatory responsibilities or commercial activities. For example, when launching in new territories, progressing from drug discovery to complete authorized clinical trials or from virtual manufacturing as a MAH to taking on commercial manufacturing activities or product distribution.
The inability to adapt to significant changes and the associated compliance risks are a surefire way to end up with a QMS that doesn’t reflect operations and pick up inspection deficiencies, FDA 483’s, and warning letters.
In this webinar, industry insider and QMS expert Charley Maxwell from Orion GXP Consulting explains how the QMS is a living, breathing system that needs regular health checks. As regulations and business operations adapt, so too must the QMS. It is never as simple as just slotting in some quick fixes that mimic the wording in the revised regulations or doing the bare minimum to meet the needs of the new operation.
Instead, he explains the advantages and introduces tools for a thorough gap analysis each time there is a significant change to review the QMS against the new regulation or commercial process. It ensures that the benefits and risks of every operation and process explained in the revised QMS are weighed and adequately assessed. It also allows the company to tabulate all the gaps, get a holistic overview of the resource needs, and make informed choices with the senior management teams.
Don’t miss this exclusive webinar. Register now and join us on 01 Sept 2022 to eliminate any gaps from your QMS.
Who Should Attend:
QA Managers, Regulatory Managers, Heads of Quality, Quality Directors
- Skill Level: Intermediate , Expert
16:00 – 16:10 Introduction
16:10 – 16:20 Why would we need to revisit the QMS?
16:20 – 16:30 Examples of where we would do a complete gap analysis
16:30 – 16:45 Gap analysis tools
16:45 –17:00 Ensuring management buy-in and follow-through
17:00 – 17:30 Summary, Q&A, and discussion
Charley MaxwellManaging Director & Consultant QP / RP
Charley is the owner and Managing Director of Orion GXP Consulting. He has over 20 years of experience working in manufacturing QA, regulatory compliance, batch release, and distribution in the pharmaceutical and medical device industry. He has assisted multiple clients with designing, developing, and implementing phase-appropriate Quality Management Systems, vendor management, audit programs, quality risk management, and training. Charley has a Bachelor’s of Science In Biochemistry and a Master’s In Pharmaceutical Manufacturing Technology. He has acted as a QP in Ireland for sterile and non-sterile manufacture, clinical IMP release, and third-country Importation.
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