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
Course Content
Course Provider
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 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
