GMPs for the Pharmaceutical Laboratory to be Inspection Ready

Tuesday, May 02, 2017 at 11:30AM - 2:30PM
San Jose, CA

Event Details

This 90 Min 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.

Objectives Of The Presentation
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:
  • Be familiar with the areas in which regulatory inspectors are likely to probe
  • Be aware of the general expectations for each of these areas
  • 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
  • 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.

For Registration


Note: Use Promo code HJQDZ and get 10% off on registration (Valid till FEBRUARY 28th 2017)

Organization Details

Online Compliance Panel (OCP) creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. OCP largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. OCP believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. OCP closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

Online Event
38780 Tyson Lane, Apt 210
San Jose, CA 94536

Starts May 02, 2017 at 11:30AM - 2:30PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896