GMP Compliance for Quality Control and Contract Laboratories 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 AGENDADay 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
samplesDay 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
discussionSPEAKERDavid L ChesneyPrincipal 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. Please contact the event manager Marilyn
(marilyn.b.turner(at)nyeventslist.com ) below for:- Multiple
participant discounts- Price quotations or visa invitation letters-
Payment by alternate channels (PayPal, check, Western Union, wire
transfers etc)- Event sponsorshipsNO REFUNDS/TRANSFERS ALLOWED ON
REGISTRATIONSPrices may go up any time. Service fees included in
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20/08/2019 Last update