New York Professional Events List


Recordkeeping and Documentation in a GLP Laboratory (COM)


Date
May 03, 2018 - 08:30 AM - May 04, 04:30 PM
Organizer
MetricStream, Inc.
Venue
DoubleTree by Hilton San Diego Downtown
Location
1646, Front St

San Diego San Diego,
CA,
USA,
ZIP: 92101
Phone:

Recordkeeping and Documentation in a GLP Laboratory (US FDA, US EPA and OSHA Focus)

 

*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***
REGISTER TODAY! 

 

GLP requires many types of documents. The seminar covers both the general issues and many specifics that laboratories can receive a non-compliance on. These range from data recording to validation issues to training records to archiving of documents.

An auditor can find numerous common errors and many, many others that are specific to a particular laboratory. This seminar will go through many of the compliance areas and point out some of both of these types. For those implementing GLP or striving to maintain certification, this course should point out many areas to examine that would lessen an unsatisfactory audit.

Most of the focus on a laboratory’s compliance with Good Laboratory Practice (GLP) or with the analogous ISO 17025 is on items such as the Standard Operating Procedures (SOPs), training, quality assurance testing, and the statistical assessment of performance and compliance. These, however, are not all that an auditor may delve into. These might the bulk of an audit, yet a laboratory may still fail an audit while doing well on all of these areas. Since laboratories focus on these, other areas might be ignored – the more mundane and simple areas, such as recordkeeping and archiving, basic laboratory operations, and safety.

 

 

Learning Objectives:

Upon completing this course, participants should:

  • Know the variety of common documentation within a compliant laboratory.
  • Understand the requirements for entering information into logbooks and also to know some of the ways that are not compliant.
  • Understand the importance of logbooks for: chemicals, instruments, calibration, maintenance and repair, calibrations, training and competence. Know the information suitable in each type.
  • Understand the requirements for recordkeeping and archiving.
 

 

 

Who will Benefit:

This course is aimed at those working in laboratories that must comply with Good Laboratory Practice or ISO 17025, especially those whose results are to be reported to the US Food and Drug Administration (FDA), the US Environmental Protection Agency (EPA), and the US Occupational Safety and Health Administration (OSHA). The various roles:

  • Managers and supervisors of the laboratory
  • Quality officers and internal auditors
  • Scientists and research associates



------------
AGENDA
------------


DAY 01(8:30 AM - 4:30 PM)
 
  • Registration Process - (8:30 am till 9:00 am)
  • Session 1 (90 Mins)
    • Recordkeeping and Archiving – Who, what, when, where, why, and how these are performed – an Overview.
  • Session 2 (90 Mins)
    • Who is responsible – what are the roles?
  • Session 3 (90 Mins)
    • What things must be recorded and archived?
    • Why is this important? The Role of Records and Documents in Compliance and Operations
  • Session 4 (90 Mins)
    • Where are specific things recorded and archived?
    • The How to keep records, the Logging System, Offsite versus Onsite Archiving.


DAY 02(8:30 AM - 4:30 PM)
 
  • Session 5 (90 Mins)
    • Basic laboratory operations - Facilities maintenance records
    • Sample entrance and records, Sample handling and storage, Chain of custody
  • Session 6 (90 Mins)
    • Sample preparation records
    • Weighing, volumetric glassware, labeling
    • Sample solution handling and records
  • Session 7 (90 Mins)
    • Stability testing! Logbooks for preparation of standards, reagents, and buffers.
    • Instrument repair and maintenance logbooks, calibration logbooks
  • Session 8 (90 Mins)
    • Prevention through the Use of Control Charts, Nelson's Rules as a Statistical Basic for such Monitoring
    • Troubleshooting and Prevention Efforts
    • Safety as a Compliance Issue

 

 

Speaker

John C. Fetzer

 

John C. Fetzer, PhD,
Consultant, Fetzpahs Consulting

Dr. Fetzer has been a method-development analytical chemist for over 3 decades. In that role he developed new methods for GC, HPLC, fluorescence spectroscopy, titrimetry, the use of ion-selective electrodes, and physical properties of aqueous solubility and octanol-water partition coefficient that complied with Good Laboratory practices. As part of his consulting and contracting work he developed GLP-compliant methods for a biopharma startup and for a petrochemical company. In all of these various efforts, numerous SOPs were written, as well as the prototype of a later-approved ASTM method. He supervised and managed a GLP compliant laboratory for over 10 years and helped maintain the documentation necessary for compliance.

 

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 sponsorship 

NO REFUNDS ALLOWED ON REGISTRATIONS 
Prices may go up any time. Service fees included in pricing. 
----------------------------------------------------------------- 
This event is brought to you by: 
MetricStream, Inc. - NewYorkEventsList 
http://www.NyEventsList.com 
http://www.BostonEventsList.com 
http://www.SFBayEventsList.com 
-----------------------------------------------------------------

VIO180102CEV MAR180106UPD EDA180216UPA

MYL180226UPD


Event Categories
BUSINESS & MANAGEMENT CONFERENCES
Keywords: fun, administration , arts, assessment , Book , development , environment, food , Fun , Health




Comments








Events Calendar

SunMonTueWedThuFriSat
29 30 1 2 3 4 5
6 7 8 9 10 11 12
13 14 15 16 17 18 19
20 21 22 23 24 25 26
27 28 29 30 31 1 2

Newsletters

Subscribe
VIP Life Time Subscription to our Newsletters!
$399.99
$299.99

Forbes Women's Summit 2018
Disrupt SF 2018 - Brought to you by Techcrunch
U.S. Naval Institute Annual Meeting 2018
Breast Cancer Research Foundation
Children’s Health Fund
The World Energy Engineering Congress (WEEC)
                            Oct. 17-19, 2018
                            Charlotte, NC