GxP Outsourcing: Ensuring Compliance and Quality in Your Operations
Overview
Oversight is important for the client and the contract manufacturing, packaging, or testing site. The MAH or CT Sponsor is ultimately responsible for the product. Therefore they must maintain scientific, quality, and regulatory oversight to ensure that their companies’ internal standards and the regulator’s expectations are met.
By delegating their responsibility to the contractor, they have a duty of care to ensure that they meet the requirements regarding the quality, safety, and efficacy of the product, whether it is a commercial marketing authorisation or a new molecule being investigated as part of a clinical trial.
So how to engage with your partner organisation be it a consultancy or logistics partner, and how to ensure the right contracts are put in place, qualifications completed, QTAs put in place, and QP-QP agreements drafted is critical.
In this one-hour webinar, we will guide you through the ongoing assessments and reviews, PQR/APR product quality reviews, risk assessments, audits, and ongoing communication and oversight requirements, as well as give you insight into what to prioritise and work on when developing their relationship with the existing partners. We will talk you through how to engage with your partner organisations be it consultancies or logistics partners and how to ensure the right contracts are put in place, qualifications completed, QTAs put in place and QP-QP agreements drafted.
Don’t miss this exclusive webinar, register now and Join us on 31 May 2023 to ensure you maximise communication and oversight of your contracted operations and deliver real value to your organisation!
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Who Should Attend:
For companies that may be looking to exploit a shortage or pricing opportunity, or who perhaps have a niche product or a candidate drug for trials but don’t have the means or expertise to bring it to market. This webinar will navigate what can and cannot be outsourced, and how to maintain effective oversight and control of the outsourced activities.
- Head of Quality
- Head of Regulatory Compliance
- Compliance Managers
- QA Managers
- Regulatory Managers
- Technical Directors
- Technical Transfer / NPI Specialists
- Skill Level: Novice, Intermediate , Expert
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Topics:
15:00 – 15:10 Introductions
15:10 – 15:15 The Contract or QTA
15:15 – 15:25 Contract Organisations – Types and level of oversight
15:25 – 15:45 Maximising Communication
15:45 – 15:55 Risk assessments, APQRs, Stability and contract reviews
15:55 – 16:00 Summary and questions
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Special event information:
- Live attendees will receive a complimentary certificate of attendance.
Speaker
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Charley MaxwellManaging Director & Consultant QP / RPCharley 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.
Partner
Orion GXP Consulting
Website
https://oriongxp.comOrion GxP Consulting provides contract QP and RP services and consultancy support to pharmaceutical manufacturing and distribution clients, such as training and expert knowledge. Orion GMP Consulting draws on the experience of our consultants and their links to the pharmaceutical industry through consulting and QP/RP roles to assist their clients in developing, managing, and continuously improving their quality systems.
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If you attend the live session you will get a digital certificate of attendance emailed to you within 7-working days.
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