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Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies (Recorded)

  • Training

  • 2 Days
  • May 3-4, 2021
  • Compliance Online
  • ID: 5626446
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 half-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

Course Content

Day 01(11:00 AM - 5:00 PM EDT)
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
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 Inspection Considerations
  • Types of inspections - GMP vs. PAI vs. Pre-License (BLA)
  • Readiness steps to consider
Day 02(11:00 AM - 5:00 PM EDT)
Phase Appropriate GMP Compliance
  • Legal basis
  • Applicability to placebos
FDA Guideline for Phase 1 GMP ComplianceFDA Guideline for Phase 2 and 3 GMP Compliance (legacy 1992 guideline no longer applicable to Phase 1)EU Annex 13 - Investigational Medicinal ProductsImportance of Data IntegrityGMP 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

Reviews

What past attendees say:

I enjoyed the practical answers and lessons learned as shared by the presenter. Grateful for the sharing of presentation material (soft copy). Thanks to ComplianceOnline for timely response and communication. Variety of choices is extensive good and easy to register.

Manager, Process Optimization,
Prolong Pharmaceuticals, LLC

Excellent instructor and he was easy to follow and I like the thorough and thoughtful answers of my questions.
Senior Scientist,
CCS Associates

Instructor is very knowledgeable and good in explaining regs and guidance. Information provided along with soft copy of slide is a great idea and very helpful.
Sr. QA Manager,
Theravance

Overall a good general overview. The amount of interaction between the participants and presenter was good.
Asst. Director QA, Clinical Packaging,
Abbott Labs

GMP expectations was the most valuable topic for me. Face to face interaction and networking was good.
Director of Pharmacy,
Pfizer New Haven Clinical Research Unit

Speaker’s knowledge was higher than I had hoped.
Director,
BioMed IRB

For me the whole event was very good. I had no knowledge of the topic prior to this seminar. The presentation was excellent and the speaker was very knowledgeable and respectful.
Quality Assurance Specialist,
Therapure Biopharma Inc.

The presenter is very knowledgeable and expert but could have made the conference more interesting. The presenter was very soft on combination drug product regulations. The whole FDA inspection discussion should have been more tailored to virtual companies.
Executive QA Director,
Ionis Pharmaceuticals

Course Provider

  • David L Chesney
  • Mr David L Chesney,
    Principal and General Manager ,
    DL Chesney Consulting, LLC (Former FDA Director)


    David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC.

    His career includes 23 years with the FDA and over 21 years in GMP and GCP consulting worldwide. In his consulting practice, Mr. Chesney helps clients prevent quality and compliance problems through proactive assessment and planning, and when necessary, with remediation planning and health regulatory authority communications.

    Until recently, he served as Vice President, Strategic Compliance Services for PAREXEL Consulting, a business unit of PAREXEL International LLC. Prior to joining PAREXEL Consulting in 1995, Mr. Chesney served 23 years with the FDA, where he advanced from Investigator to Supervisory Investigator and Director, Investigations Branch, working in the Boston, Seattle and Philadelphia District Offices. In 1991, he was appointed the District Director, FDA San Francisco District Office, where he served until joining PAREXEL in 1995. For 19 years, he led the Strategic Compliance Consulting group, and also personally provided regulatory enforcement related consulting services to the pharmaceutical, medical device and biologics industries, plus technical assistance to legal counsel in FDA regulatory matters. Mr. Chesney has a bachelor's degree and postgraduate credits in biology from California State University, Northridge and San Diego, and received a Certificate in Health Care Compliance from Seton Hall University School of Law.

Who Should Attend

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