ComplianceOnline

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.

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:

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
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Day 01(8:30 AM - 4:30 PM)
  • 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
Day 02(8:30 AM - 4:30 PM)
  • 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
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David L Chesney

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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Local Attractions of Hayward, CA

Japanese Gardens

Japanese Gardens

The Hayward Japanese Gardens, located near downtown Hayward, are the oldest Japanese gardens in California designed along traditional lines. The park's current area was fully acquired by 1976, and the park was dedicated in 1980. The garden was designed following Japanese garden design principles, using California native stone and plants. No stains were used on the wood constructions. Nails and fasteners are recessed, and all wood was notched, and aged, to simulate the appearance of a traditional Japanese garden.

Hayward Regional Shoreline

Hayward Regional Shoreline

Hayward Regional Shoreline is a regional park located on the shores of the San Francisco Bay in Hayward. It is part of the East Bay Regional Parks system. The 1,713 acre park extends to the shores of San Lorenzo. Part of the park is former commercial salt flats purchased in 1996. A former landfill, now capped with soil and plants, is located in the park. The park includes the 250 acre tidal wetland, Cogswell Marsh, and the 364 acre Oro Loma Marsh (constructed in 1997). Located to the south of the park is the Hayward Shoreline Interpretive Center, which provides information on the Bay shore habitats. The San Francisco Bay Trail runs through the park, which connects the park with San Lorenzo Creek.

San Lorenzo Creek

San Lorenzo Creek

San Lorenzo Creek is a 10.7-mile-long year-round natural stream flowing through Hayward, California, into San Francisco Bay at the Hayward Regional Shoreline. The creek begins in Castro Valley, and is the main tributary within the San Lorenzo Watershed, including the formerly independent Sulpher Creek, which had most of its flow diverted into San Lorenzo Creek in the 1960s to reduce the risk of flooding in downtown Hayward. Only in large flow events does some of the creek flow follow its old course into the Bay. The creek runs through the town of San Lorenzo and empties into San Francisco Bay. A portion of the San Francisco Bay Trail runs along the mouth of the creek. The Cull Canyon and Don Castro reservoirs, both located within regional parks, feed into the creek.

Hayward Shoreline Interpretive Center

Hayward Shoreline Interpretive Center

The Hayward Shoreline Interpretive Center is a natural history and ecology interpretive nature center located in Hayward, California. It is directly adjacent to the north side of Highway 92 as it approaches the San Mateo–Hayward Bridge, and is accessed from the highway by the last offramp in the westbound direction before the bridge toll gates. The Center was dedicated in 1986, and focuses on San Francisco Bay wetland and shoreline ecosystems, and is itself located next to restored wetlands formerly used as salt ponds. The Center operates primarily as a resource center for local schools' educational field trips. It is open to the public on weekends. The center has a small permanent exhibit of native, aquatic life, and rotating exhibits of other related subjects. Binoculars are on loan for birdwatching.

Cull Canyon Regional Recreation Area

Cull Canyon Regional Recreation Area

Cull Canyon Regional Recreation Area is a regional park located in Castro Valley, CA that is part of the East Bay Regional Parks system. The EBRPD's web-site reports that "The [recreation area's] lagoon won the 1966 Governor's Design Award for Exceptional Distinction for Recreational Development in the category of landscape." The recreation area is open for swimming seasonally.

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