Quality and GMP Compliance For Virtual Companies Seminar: New Perspective For Professionals - Setting the Course for Commercial Success

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Aug 16, 2023, 19:00 ET

DUBLIN, Aug. 16, 2023 /PRNewswire/ -- The "Quality and GMP Compliance For Virtual Companies - New Perspective For Professionals" training has been added to ResearchAndMarkets.com's offering.

This seminar on GMP compliance is typically designed for virtual companies that are going to welcome the commercial growth phase in the coming time.

Running a pharmaceutical company is not easy, especially if you have an outsourcing model. There are multiple crucial steps for which you need to depend on contract manufacturers and researchers. Additionally, due to the majority of outsourced products, the team may lack quality assurance and GMP compliance.

To evolve from your current expertise and enter Phase 2 and 3 of clinical trials, it is essential to have a strong hold on pharmaceutical GMP compliance. This seminar consists of two days of rigorous training for professionals from virtual companies. You will learn all major requirements and expectations that are applicable to you and your team.
Course Overview

As a virtual company also, it is your responsibility to adhere to the guidelines laid by FDA, EMA, and Health Canada. However, the first step is to diagnose your company's requirements and pick industry best practices to be followed.

The pharma GMP compliance for virtual companies is not just limited to your own practices. It is essential to choose the right contractors after proper qualification testing and monitoring. In addition to strengthening your brand or business's value, this training will allow you to grow and expand in the coming months.

Some of the benefits of knowing the prerequisites of GMP audits are:

Function beyond the outsourcing model
Choose the right contractors and C-level executives for your business.
Formulate a top-notch quality agreement.
Align your internal operations with that of the outsourced.
Release your product successfully for clinical and market use
Manage the inspections by responding with the required documents.

Who Should Attend:

Quality Managers and Analysts: Gain ideas about managing product quality when the company transitions from an outsourcing model.
Clinical Operations: Understand the requirements for a clinical product's approval in the market.
Document Control Specialists: Learn the requirements of the FDA in terms of documents so that you can present them during the inspection.
Regulatory Professionals: Supervise the overall function and perform internal audits effectively.

Agenda

DAY 01 (12:00 PM - 04:00 PM EDT)

Introductions and participant expectations for the program
Fundamentals of Good Manufacturing Practice
What is GMP?
Purpose of GMP
Basis in law: US, Europe, Canada
Elements that apply to all virtual companies
Elements that depend on how operations are conducted: How to tell what applies to your company

Data Integrity: What it is and why it is important to GMP

Fundamentals of Good Clinical Practice (GCP)
What is GCP?
Purpose of GCP
Basis in law: US, Europe, Canada
Elements that apply to all virtual companies
Elements that depend on how operations are conducted: How to tell what applies to your company

Regulatory and business risks: The case for compliance

Virtual company organizational structure and responsibility for QA/GMP/GCP
Virtual company quality system structure and management
Policies, procedures, documentation management
Metrics and management review considerations

Selection, qualification, and monitoring of contractors

Initial due diligence - public information sources to gage compliance
Qualification of vendors
Quality agreements - determining and documenting responsibilities for GMP
Vendor audit program
Day One Q&A and recap of progress meeting stated course expectations

DAY 02 (12:00 PM - 04:00 PM EDT)

Regulatory Inspections
Purpose of an inspection
Reasons for inspections
Inspections at virtual company headquarters locations - purpose and scope
Inspections at CMOs and Contract Labs
GMP inspections versus Preapproval inspections - FDA
GCP inspections of sponsors of clinical trials
EMA inspections - contrast with FDA
Health Canada inspections

Logistics for managing inspections at your location

Information sources about inspections on agency websites: What you need and how to find it easily
Preparation for inspections
Overall process - ready room support
Receiving and hosting the inspectors
Providing documents
Answering questions
Interpersonal dos and don'ts for interacting with inspectors
Managing the exit discussion at the conclusion of the inspection

Inspections at your contract organizations

Make sure your CMO and contract lab are "PAI ready"
Training employees to assure inspection readiness - pitfalls to make sure you avoid
Conducting mock inspections effectively

Post-inspection communications with the inspecting agency

How to write an effective response
Common mistakes to avoid
Following up to ensure the response is satisfactory
When to request a meeting, and if granted, how best to handle it

Enforcement considerations

FDA enforcement process - domestic and ex-US
EMA enforcement
Health Canada
Final Q&A, discussion, and conclusion

Speakers:

Kelly Thomas
Vice President
Stallergenes Greer

Ms. Thomas has over two decades of GMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

For more information about this training visit https://www.researchandmarkets.com/r/himsdn

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