ComplianceOnline

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

Instructor: Gregory Martin
Product ID: 702534
Training Level: Intermediate
  • 8
  • November 2017
    Wednesday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 120 Min

Live Online Training
November 08, Wednesday 10:00 AM PST | 01:00 PM EST | Duration: 120 Min

$199.00
One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD free!

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD

$349.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD

$449.00

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.

Why Should You Attend:

This laboratory inspection course is designed to provide participants with an understanding of the areas which are likely to be the subject of a laboratory inspection, whether it is a Pre-Approval Inspection or a general GMP inspection. By understanding the expectations, the participants will be able to develop a strategy to minimize issues should their laboratory be inspected.

Upon completion of this course the participant should:

  1. Be familiar with the areas in which regulatory inspectors are likely to probe.
  2. Be aware of the general expectations for each of these areas.
  3. Develop an overall strategy to minimize the likelihood of issues arising during an inspection.

Due to the diverse interests of the participants, questions will be actively solicited and addressed by the end of the webinar.

Areas Covered in the Webinar:

  • Types of Inspections.
  • Personnel Organization and Records.
  • Instrument Inventory, Qualification and Change Control.
  • Key SOPs Every Lab Should Have, and Related Training and Maintenance.
  • Log of Out of Specification Results.
  • Documentation of Analytical Procedures, including Validation, Verification and Change Control.
  • Documentation of Analytical Data and Reports.
  • Trending of Analytical Data, Laboratory Incidents and OOS Reports.
  • Brief Introduction to Expectations for Computer Systems.
  • Attendee Questions and Answers.

Who Will Benefit:

  • Chemists
  • Laboratory Managers
  • Regulatory Affairs
  • Quality Assurance personnel responsible for generating GMP or GLP data or assuring readiness for a regulatory inspection
  • IT/IS
  • Documentation
Instructor Profile:
Gregory Martin

Gregory Martin
Founder and President, Complectors Consulting LLC.

Gregory Martin is President of Complectors Consulting (www.complectors.com), which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years’ experience in the pharmaceutical industry, including Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company to solving challenging problems. He provides consulting services to over 50 companies, including human and veterinary pharmaceutical companies, manufacturers of OTC and nutritional supplement products, and contract organizations.

In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters – Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He also serves on the Steering Committee of the AAPS IN Vitro Release and Dissolution Testing Focus Group.

He has particular interest in QbD/Lean approaches to dissolution testing, method lifecycle (development/validation/transfer), impurity testing and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is has presented at several scientific meetings, and authored of several papers in the areas of dissolution and analytical method validation.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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