Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)


 Course Description - Today, many companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering latter stages of Phase 2 or Phase 3 clinical trials, and plan to have a product ready for market approval in the coming months. Most such companies are small, and may not have deep expertise in QA and GMP compliance seminars, relying on their partners to cover those areas. Companies who outsource the majority of operations through the use of Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs) and Contract Laboratories, however, remain responsible for the quality and compliance status of the products they send to the clinic or to the marketplace.


In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies. You will learn how to diagnose your company's needs based on which GMP and GCP-governed operations you retain and which you outsource; what the current expectations and best industry practices are for selecting, qualifying and monitoring your contractors to ensure they are meeting your requirements; and how to build a quality system framework that is not excessive for your current needs, but has the structure and integration to "grow with you" as the scope your operations change in the coming months and years.


You will also learn best practices for managing a regulatory inspection, with emphasis on FDA, EMA and Health Canada, but applicable to most other major agencies as well.


Learning Objectives:

Participants in this seminar will:

Understand the GMP and GCP requirements all virtual companies must meet regardless of the extent of their outsourcing operations

Understand how to select, qualify and monitor CMOs, CROs and Contract Laboratories

Learn the elements to include in a quality agreement (also known as a technical agreement)

Learn how to determine which GMP or GCP requirements apply to you, depending on the things you do internally and those you outsource

Understand your obligations under the law for products you release to the clinic or the marketplace

Appreciate the importance of maintaining data integrity

Learn how to effectively manage a health regulatory inspection:

Inspection logistics

Responding effectively to document requests and questions from inspectors

Managing the inspection exit discussion

How to write an effective response to inspection observations

How to find applicable inspection references and procedures of the FDA, EMA and Health Canada


Agenda


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 Training Online

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(9:00 AM - 3:00 PM PDT)

Regulatory Inspections / Online Regulatory Compliance Training


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 web sites: 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

Making 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

4:30 PM: Adjourn

Who will Benefit

This course is designed for those charged with managing Quality Assurance and Regulatory Affairs for companies in the development or commercial phase of growth who either release investigational drugs to clinical trial sites or send commercial products to the market, but rely to a great extent on the use of Contract Manufacturers and/or Contract Laboratories. The following personnel will benefit from the course:


Senior quality managers in manufacturing QA/GMP or clinical quality areas

Quality professionals

Regulatory professionals

Clinical Operations

Compliance professionals

Quality auditors – GMP and GCP

Document control specialists

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