This program will cover the requirements for laboratory controls under US GMP regulations and compare them to those applied by other international health regulatory authorities. Laboratory controls relating to equipment calibration and preventive maintenance; sample chain of custody; good documentation practices; investigation of out of specification and out of trend results; analytical method validation; change control; impact of staffing levels and work flow patterns in the lab on GMP compliance; training and other issues will be included under laboratory controls. The program will also examine the impact of the benchmark court ruling in US versus Barr Laboratories on QC laboratory governance under GMP; the role of the QC Laboratory; its placement in the overall organizational structure of a company; the responsibility of a contract laboratory versus an in-house laboratory; regulatory requirements and expectations concerning the relationship between a contract laboratory and the company who gives the contract; the criticality of data integrity, with special emphasis on recent laboratory related issues that have arisen internationally, and case studies focusing on a review of common laboratory inspection observations.
Learning Objectives:
Upon completing this course participants should:
- Understand the fundamental laboratory controls mandated under US and various other international GMP regulations
- Understand the global influence of the landmark US versus Barr Laboratories case, why it matters outside of the United States, what the original objective of the ruling was and how its influence has spread internationally and impacted laboratory GMP governance world wide
- Understand the principles of investigation of out of specification and out of trend results and why they are important to GMP compliance
- Understand the expectations of regulatory authorities about the organizational placement of the QC lab and its relationship to QA and Manufacturing units
- Understand the expectations of regulators regarding contract givers and contract receivers in outsourced laboratory operations and how those should be managed under GMP
- Appreciate the importance of maintaining rigorous data integrity standards, particularly regarding laboratory computer systems; know the problems and pitfalls to avoid, understand the implications of the use of metadata and what to do with audit trails for computer systems
Who will Benefit:
This course is designed for people tasked with developing, maintaining and/or improving Quality Management Systems for laboratory operations, working in or managing QC laboratories, or for qualifying and auditing contract laboratories.
- Laboratory scientists and managers
- Quality Assurance professionals
- Regulatory Affairs professionals
- Compliance professionals
- GMP Auditors
- Anyone with management or oversight responsibility for QC Lab operations
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- Introductions and setting of attendee’s objectives – What do you want to get from this seminar?
- Basics of FDA law and regulations for QC laboratories
- Concept of “adulteration” under the law as applied to:
- Pharmaceuticals
- Biologics
- Medical Devices
- Foods
- Cosmetics
- What is “CGMP” and how does it apply to:
- Pharmaceuticals
- Biologics
- Medical Devices
- Foods
- Cosmetics
- What is “GLP”?
- What is the “AIP”?
- Use of Contract Laboratories
- Reliance on Certificates of Analysis
- Quality agreement guidance from FDA
- Monitoring and auditing laboratory performance
- Laboratory Organization
- Organization and reporting structure: Requirements versus “expectations”
- Personnel qualification and training
- Documentation and record-keeping requirements
- Standard Operating Procedures
- Analytical Methods
- Raw data (notebooks, print-outs)
- Document management (change control, retention)
- Part 11 (electronic records and signatures)
- Sample integrity requirements
- Sample collection
- Sample delivery, handling, disposition
- Retain samples
- Check in from day one: Compare topics covered to attendee objectives stated on day one
- Stability (shelf-life) studies
- Organization and management of the stability program
- Storage units
- Stability indicating methods
- Analytical method validation
- Validation Protocols
- Tests
- Documentation
- Management and control of laboratory instruments
- Qualification
- Calibration
- Maintenance
- Management and control of laboratory supplies
- Standards
- Reagents, chemicals
- Proper conduct of laboratory out of specification/out of trend investigations
- Out-of-specification results
- Out-of-trend results
- Root cause analysis
- Documentation practices and data integrity
- Consequences of laboratory non-compliance – enforcement basics
- Final Q&A and open discussion
David L Chesney
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)
David L. Chesney, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide. He has 47 years experience, evenly divided between the FDA and the private sector, including over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii.
Mr. Chesney has an MS degree in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law from Seton Hall University School of Law, a Bachelor's degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego. Mr. Chesney is a member of the Parenteral Drug Association, where he serves on the faculty of the PDA Training and Research Institute. He is also active in the Food and Drug Law Institute and RAPS.
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The Franklin Institute
An innovator in designing hands-on exhibits before “interactive†became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.
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The Barnes Foundation
The Barnes Foundation was created in 1922, a school originating with Barnes’ educational experimentation in his Argyrol (pharmaceutical) factory. Barnes and The Foundation’s first director of education, John Dewey, were interested in fostering cognitive development through new approaches to education, and in heightening critical-thinking and problem-solving skills through the study of art. Barnes, like Dewey, was actively engaged in development of an intellectual framework and educational philosophies and practices with many of the best artists and thinkers of his day.
The Rocky Statue
One of Philadelphia’s most famous pieces of public art is a bigger-than-life boxer… literally. Originally created for Rocky III, the sculpture is now a real-life monument to a celluloid hero. The fictional Rocky Balboa of Sylvester Stallone’s Rocky movies was immortalized in bronze in 1980. After filming for the movie completed, Stallone donated the statue to the City of Philadelphia.
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Franklin Square, one of Philadelphia’s five original public squares laid out by William Penn in his original plan for the city, has undergone a dramatic renovation. The park now boasts several family-friendly attractions, including a miniature golf course, classic carousel, burger joint, storytelling bench, picnic area and more.
