Conference Description:

Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)


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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, 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.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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



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



AGENDA

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

08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
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(8:30 AM - 4:30 PM)

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 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



SPEAKER

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.



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