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

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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

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

The real-time and live presentation as in in-person events
Private chat for company-specific conversation – the same as you would get in an in-person seminar
Opportunities to connect with your peers to share knowledge at a different time and have group discussions
Live workshop activities
Live Q&A during the event and offline Q&A assistance after the event
As usual more content, activities and case studies and now adding homework for a comprehensive understanding
Certification

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Day 01(9:00 AM to 5:00 PM EST)

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(9:00 AM to 5:00 PM EST)

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

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.

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1
January 21-22, 2020
Virtual Seminar

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$1,699.00

(One Dial-in One Attendee)

January 21-22, 2021, Virtual Seminar
(Registrations till December 30, 2020 - $1699)
(Registrations after December 30, 2020 - $1999)

$8,665.00

Group-Max. 10 Attendees

January 21-22, 2021, Virtual Seminar
(Registrations till December 30, 2020 - $8665)
(Registrations after December 30, 2020 - $10195)

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Note: In view of Coronavirus situation and travel advisory issued, ComplianceOnline will waive off all cancellation charges for the registrations till December 30, 2020.

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Payment:

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions for In-person Seminars:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.

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Early bird seats are limited and based on first-come, first-serve.

Multiple offers cannot be combined.