Seminar on Quality and GMP Compliance for Virtual Businesses: Pharmaceutical and Biologics Industries – September 28-29, 2022 –

DUBLIN–(BUSINESS WIRE)–The “Quality and GMP compliance for virtual companies (pharmaceutical and biological industries)” training has been added to from offer.

In this two-day conference-workshop, you will learn about the requirements and expectations of major health regulators that apply to “virtual” businesses.

Many companies today operate on an outsourcing model. This is very common for companies that are moving from a primarily development-focused approach to a point where they are entering the later stages of phase 2 or phase 3 clinical trials and plan to have a product ready for approval. market in the coming months.

Most of these companies are small and may not have deep expertise in QA and GMP compliance, relying on their partners to cover these areas. Companies that outsource the majority of operations using Contract Manufacturing Organizations (CMOS), Contract Research Organizations (CROs) and Contract Laboratories, however, remain responsible for product quality and compliance. products they send to the clinic or hospital. market.

You will learn how to diagnose your business needs based on the GMP and GCP governed operations you retain and those you outsource; what are the current expectations and industry best practices for selecting, qualifying and monitoring your contractors to ensure they meet your requirements; and how to build a quality system framework that is not overkill for your current needs, but has the structure and integration to “grow with you” as the scope of your operations changes over the months and years. coming.

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

Learning objectives:

The participants in this seminar:

  • Understand the GMP and GCP requirements that all virtual businesses must meet, regardless of the scope 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 called technical agreement)

  • Learn how to determine which GMP or GCP requirements apply to you, based on what you do in-house and what you outsource

  • Understand your obligations under the law for the products you distribute at the clinic or market

  • Appreciate the importance of maintaining data integrity

  • Learn how to effectively manage a health regulatory inspection:

    • Control logistics

    • Respond effectively to requests for documents and questions from inspectors

    • Management of the inspection exit discussion

    • How to Write an Effective Response to Inspection Observations

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

Who should attend:

This course is designed for individuals responsible for managing quality assurance and regulatory affairs for development-stage or commercial-growth companies that release investigational drugs to clinical trial sites or send commercial products to the market, but depend to a large extent on the use of contract manufacturers and/or contract laboratories.

The following personnel will benefit from the course:

  • Senior Quality Managers in the areas of Manufacturing QA/GMP or Clinical Quality

  • Quality professionals

  • Regulatory Professionals

  • Clinical operations

  • Compliance professionals

  • Quality auditors – GMP and GCP

  • Document control specialists

Main topics covered:

DAY 01

Introductions and expectations of participants for the program

Fundamentals of Good Manufacturing Practices

  • What is GMP?

  • Purpose of GMPs

  • Legal basis: United States, Europe, Canada

  • Elements that apply to all virtual businesses

  • Elements that depend on how operations are conducted: How to tell what applies to your business

Data Integrity: What It Is and Why It Matters for GMP

Fundamentals of Good Clinical Practice (GCP)

  • What is GCP?

  • Purpose of GCP

  • Legal basis: United States, Europe, Canada

  • Elements that apply to all virtual businesses

  • Elements that depend on how operations are conducted: How to tell what applies to your business

Regulatory and business risks: the case for compliance

Virtual enterprise organizational structure and responsibility for QA/GMP/GCP

Structure and management of the quality system of the virtual company

  • Policies, procedures, documentation management

  • Management review metrics and considerations

Selection, qualification and monitoring of service providers

  • Initial due diligence – public sources of information to assess compliance

  • Qualification of sellers

  • Quality agreements – determine and document responsibilities for GMP

  • Supplier audit program

Day 1 Q&A and recap of progress meeting indicated course expectations

DAY 02

Regulatory visits

  • Purpose of an inspection

  • Reasons for inspections

  • Inspections in the company’s virtual headquarters – purpose and scope

  • Inspections in CMOs and contract laboratories

  • GMP inspections versus pre-approval inspections – FDA

  • GCP inspections of clinical trial sponsors

  • EMA inspections – unlike the FDA

  • Health Canada inspections

Logistics for the management of inspections on your site

  • Sources of inspection information on agency websites: what you need and how to find it easily

  • Preparing for checks

  • Overall process – prep room support

  • Reception and accommodation of inspectors

  • Provide documents

  • To answer questions

  • The Dos and Don’ts of Interacting with Inspectors

  • Manage the exit discussion at the end of the inspection

Inspections in your contractual organizations

  • Ensure that your CMO and your contract laboratory are “PAI ready”

  • Employee training to ensure inspection readiness – pitfalls to avoid

  • Efficiently perform mock inspections

Post-inspection communications with the inspection body

  • How to write an effective response

  • Common mistakes to avoid

  • Follow up to ensure response is satisfactory

  • When to request a meeting and, if granted, how best to manage it

Application Considerations

  • FDA Enforcement Process – Domestic and Non-US

  • Application of EMA

  • Health Canada

Final questions and answers, discussion and conclusion

4:00 p.m.: Adjournment

For more information on this training, visit