ComplianceOnline

Microbiology Laboratory Regulatory Compliance Training - Live Webinars, Recordings & CDs

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory
31
/ Jan
Thursday-2019

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

  • Speaker: Gregory Martin
  • Product ID: 702534
  • Duration: 120 Min
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.
* Per Attendee
$199
Recorded/CD
Gaining and Re-establishing Control of Your Cleanroom

Gaining and Re-establishing Control of Your Cleanroom

  • Speaker: Joy McElroy
  • Product ID: 705317
  • Duration: 60 Min
This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.
CD/Recorded
$249
Recorded/CD
Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances

Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances

  • Speaker: Michael Brodsky
  • Product ID: 704861
  • Duration: 60 Min
This RCA webinar will define a specific set of steps and associated tools that you can use to determine the primary cause of non-conformance in your laboratory. You will learn to determine what happened, why it happened and how to reduce the likelihood of that non-conformance happening again.
CD/Recorded
$249
Recorded/CD
Measurement Uncertainty in Microbiology

Measurement Uncertainty in Microbiology

  • Speaker: Michael Brodsky
  • Product ID: 703902
  • Duration: 60 Min
This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples.
CD/Recorded
$249
Recorded/CD
How to undergo an FDA Inspection Successfully

How to undergo an FDA Inspection Successfully

  • Speaker: Marie Morin
  • Product ID: 705170
  • Duration: 90 Min
This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.
CD/Recorded
$249
Recorded/CD
Objectionable Microorganisms in Biopharmaceutical Manufacturing

Objectionable Microorganisms in Biopharmaceutical Manufacturing

  • Speaker: Carl Patterson
  • Product ID: 705319
  • Duration: 60 Min
This webinar will discuss the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place.
CD/Recorded
$249
Recorded/CD
Safe Drinking Water - Another Oxymoron?

Safe Drinking Water - Another Oxymoron?

  • Speaker: Michael Brodsky
  • Product ID: 703944
  • Duration: 60 Min
This training program will discuss the sources and causes of waterborne disease and what microbial options are available to assess and minimize the risk.
CD/Recorded
$249
Recorded/CD
Leadership in Manufacturing Contamination Control:  The Microbiology Lab

Leadership in Manufacturing Contamination Control: The Microbiology Lab

  • Speaker: T.C Soli
  • Product ID: 701478
  • Duration: 60 Min
This webinar on Contamination Control will discuss, how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve problems like recurring micro failures, investigations, and ineffective CAPAs.
CD/Recorded
$249
Recorded/CD
Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)

Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)

  • Speaker: Barry A Friedman
  • Product ID: 705433
  • Duration: 90 Min
The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.
Recorded/CD
FDA Inspections: What Regulations Expect

FDA Inspections: What Regulations Expect

  • Speaker: Joy McElroy
  • Product ID: 705346
  • Duration: 90 Min
Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.
CD/Recorded
$249
Recorded/CD
Sterilization of Pharmaceutical Products and Medical Devices

Sterilization of Pharmaceutical Products and Medical Devices

  • Speaker: Carl Patterson
  • Product ID: 705310
  • Duration: 60 Min
This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method.
CD/Recorded
$249
Recorded/CD
The Revised Total Coliform Rule (RTCR)

The Revised Total Coliform Rule (RTCR)

  • Speaker: Michael Brodsky
  • Product ID: 705279
  • Duration: 60 Min
This training program will discuss in detail the requirements of Revised Total Coliform Rule (RTCR) including its history and background, key provisions, comparison with the TCR (Total Coliform Rule) and much more. It will also describe the best practices to comply with the RTCR requirements.
Recorded/CD
How to prepare a winning Standard Operating Procedure (SOP)

How to prepare a winning Standard Operating Procedure (SOP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705131
  • Duration: 60 Min
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
Recorded/CD
Quality Control for Microbiological Media and Reagents

Quality Control for Microbiological Media and Reagents

  • Speaker: Todd Graham
  • Product ID: 705060
  • Duration: 60 Min
This webinar will give you the tools you need to maintain a quality supply of media and reagents in a variety of microbiology laboratories. A thorough understanding of the variety of challenges necessary in maintain quality media and reagents will be brought to the fore. This will allow you to perform microbiology testing with confidence.
CD/Recorded
$249
Recorded/CD
Performing an Effective Out-of-Specification Result Investigation

Performing an Effective Out-of-Specification Result Investigation

  • Speaker: Charity Ogunsanya
  • Product ID: 705064
  • Duration: 90 Min
This webinar will provide the basic understanding of how to conduct a compliant and effective out-of-specification (OOS) result investigation which is critical in preventing product recalls, voluntary and involuntary plant shut down, and FDA 483 findings or warning letter. It will also provide a basic mainframe for the Quality Assurance unit in the final disposition of the affected finished product as well as provide guidance for the different types of OOS investigational systems.
Recorded/CD
Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

  • Speaker: Henry Urbach
  • Product ID: 705072
  • Duration: 90 Min
This webinar you will discuss how to help your organization get a better handle on what is an “objectionable microorganism, ” exactly how “objectionable” it really is and what you can do to minimize the risk if you find one in your process or product.
CD/Recorded
$249
Recorded/CD
Basic Concepts of Sterility Assurance

Basic Concepts of Sterility Assurance

  • Speaker: Mark Seybold
  • Product ID: 705046
  • Duration: 90 Min
This course will provide a foundation for developing your technical skills related to sterility assurance.
Recorded/CD
Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)

Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)

  • Speaker: Charity Ogunsanya
  • Product ID: 705018
  • Duration: 90 Min
This webinar training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.
Recorded/CD
Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

  • Speaker: Henry Urbach
  • Product ID: 703058
  • Duration: 90 Min
This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.
CD/Recorded
$199
Recorded/CD
SOP's for Bioanalytical Methods Validation

SOP's for Bioanalytical Methods Validation

  • Speaker: Todd Graham
  • Product ID: 704916
  • Duration: 60 Min
This webinar will help you learn how to validate bioanalytical methods. This session will teach you the pitfalls behind bioanalytical methods validation, allowing one to transition between assays with ease.
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