Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies

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This program combines general considerations for Good Manufacturing Practice (GMP) compliance management with the principles of phase-appropriate GMP considerations, with an emphasis on needs of virtual companies. (“Virtual companies” are those who outsource GMP operations to Contract Manufacturing Organizations (CMOs) and Contract Analytical Laboratories.)

Virtual companies typically do not conduct “hands on” manufacturing, but do perform tasks which are governed by GMP, for example, dispositioning final product, managing the supply chain, investigating complaints, and providing training to staff in GMP compliance concepts. Such companies often struggle to decide how to structure their quality management system, which procedures they need or do not need, and how to best manage vendor relationships. In addition, the application of GMP requirements to the manufacture of investigational products requires exercise of judgement over the life cycle from early phase (Phase 1) to peri-approval (late Phase 3). Understanding what is required by FDA and other regulatory agencies is important to assure timely approval, since GMP compliance issues can result in approval delays.

In this two day workshop conference you will learn how GMP applies directly to virtual company operations, how to best structure a quality management system in a virtual company, and a method to decide which procedures are necessary at what points in time. You will also learn best practices for quality agreements and vendor management. In addition, you will learn the current guidance from FDA for application of GMP to the manufacture of Phase 1, 2 and 3 clinical trial materials. Though FDA requirements are the primary emphasis, some discussion of EMA (European) requirements and other venues will also be included.

Learning Objectives:

Upon completing this course participants should:

  • Understand the fundamentals of GMP for the United States
  • Understand how to determine what GMP-governed operations you are performing internally versus what you are outsourcing
  • Understand a method to structure your quality management system and decide which procedures you need now versus which ones can wait
  • Understand best practices for vendor management
  • Learn how to apply GMP concepts to Phase 1, 2 and 3 investigational drugs
  • Learn the differences between an FDA GMP inspection, a Pre-Approval Inspection and a Pre-License Inspection and where to obtain guidance for each
  • Understand basic principles of FDA inspection authority, what to expect if FDA inspects your virtual firm, and how to manage the presence of FDA personnel on site

Who will Benefit:

This course is designed for persons responsible for GMP compliance management following a virtual model, both pre- and post-market. Though designed with small company needs in mind, the principles are also useful to those in larger companies who manage CMOs, particularly those manufacturing investigational drug API and finished products:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Quality engineers
  • Quality auditors

DAY 01(8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration

09.00 AM: Session Start

Introduction and objectives

Virtual Company Challenges

  • Importance of quality management to business success

GMP defined and the Legal basis of GMP

  • Meaning of the term “Manufacturing”
  • CMO Role
  • Role of the contracting company
  • Specific GMP requirements that apply to virtual companies

Structuring a Quality Management System in a Virtual Company Setting

  • Structuring the organization and the Quality Unit
  • Structuring a document control hierarchy
  • Determining what procedures to have in place
  • Development of Quality Standards

Supply Chain Quality Management

  • Legal basis for this requirement of GMP
  • Vendor selection considerations
  • Quality Agreements
  • Vendor auditing system (frequency, depth, obstacles to overcome)

FDA Inspections of Virtual Companies

  • Authority and scope of access
  • Reasons for FDA inspections of virtual companies
  • Special considerations for Prre-Approval (NDA/BLA) inspections
  • Logistic considerations for managing FDA presence on site
  • Answering interview questions
  • Regulatory correspondence: Responding to FDA-483s, other post inspection correspondence

DAY 02(9:00 AM - 4:00 PM)

09.00 AM: Session Start

Phase Appropriate GMP Compliance

Legal basis

Applicability to placebos

FDA vs. EMA inspection considerations

FDA Guideline for Phase 1 GMP Compliance

FDA Guideline for Phase 2 and 3 GMP Compliance (legacy 1992 guideline no longer applicable to Phase 1)

EU Annex 13 – Investigational Medicinal Products

Importance of Data Integrity

GMP data versus “application data” and importance to PAI/PLI Success

Practical application of GMP principles to investigational drug manufacturing

  • Facility considerations – size, scale
  • Equipment qualification
  • Process and analytical method validation issues
  • Scale-up issues
  • Sterility and environmental control
  • Stability issues
  • Procedures – level of detail
  • Master and batch production and control records
  • Change control – at what point does this apply?
  • Deviation investigation
  • Batch disposition and role of the Quality Unit at the CMO vs the Virtual Company

Final discussion, Q&A

Seminar (Price/Register)
Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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