During this complimentary consultation, we will discuss how to optimize your Quality Management System (QMS) to enhance efficiency and compliance. Do you need assistance with implementing your QMS, or do you require help with remediating or improving your existing processes? Do you need hands-on support for your day-to-day operations, or high-level QMS oversight at the senior leadership level? During this session, you will describe the project scope, expected outcomes, and any identified roadblocks that need addressing. Together, we will brainstorm potential solutions. Expected Outcomes: - Overview of your current QMS - Discussion of potential gaps to be addressed or areas for improvement - Determination of whether regular or fractional consulting is more suitable for your needs - Development of a preliminary plan to enhance your QMS

During this session I will provide practical guidance on how to proactively prepare for regulatory inspections (e.g., FDA, EU), even if unannounced! Learn how to promptly setup a control room and be inspection ready after trying the tips I will share in this session. After this session you should be able to: - Understand the concept of inspection readiness and its importance. - Learn how to set up a control room for regulatory inspections. - Identify the key elements of a successful Inspection Readiness Plan - Gain insights into common pitfalls and how to avoid them.

During this complimentary consultation, we will discuss how Fractional Consulting offers a cost-effective solution for startups and small organizations that require flexible, scalable QA/QMS support without the commitment of a full-time staff member. As a Head of QA, I will provide ongoing quality expertise on a part-time basis, whether hourly, retainer, or project-based. You determine the number of hours or days per week you need my services, the scope of work to be completed, and the anticipated length of service. Together, we will develop a plan that aligns with your budget and meets your quality objectives. Expected Outcomes: - Assess if Head of QA Fractional Consulting aligns with your organizational needs - Overview of how fractional consulting can benefit your organization - Development of a tailored plan that aligns with your budget and quality objectives

During this free consultation, we will discuss your quality needs and how my services can help you achieve these objectives, all within your budget. Expected Outcomes: - Understand your specific quality needs and objectives. - Identify which services best suit your requirements. - Develop a preliminary plan to address your quality challenges. - Gain insights into how our collaboration can benefit your organization.

In this session, I'll share some tips on technical writing to make written procedures easier to understand, easier to follow, and easier to execute. Learn how to craft clear, concise, and effective SOPs that enhance compliance and streamline operations. After the session you should be able to: - Understand the importance of well-written SOPs - Learn key technical writing techniques for clarity and simplicity - Explore best practices for structuring and formatting SOPs - Determine the best training method to ensure effective SOP implementation - Gain insights into common pitfalls and how to avoid them

During this complimentary consultation, we will discuss the auditing services available and which audit plan would best fit your scope and budget. I offer a range of audit packages to provide flexible options for my clients. Whether you require a single audit or comprehensive audit program management; I am equipped to meet your auditing needs. Expected Outcomes: - Discuss type of auditing services offered - Overview of available flexible GxP vendor audit packages - Guidance on selecting the most suitable audit plan for your organization

During this free consultation, we'll discuss your vendor management needs and understand the challenges you face that need support. Expected Outcomes: - Overview of your current vendor management processes - Discussion of potential gaps and areas for improvement - Discuss potential plan to enhance your vendor management and oversight program

This session will be live. Your registration will be confirmed once all seats are filled.