ComplianceOnline

Biotechnology Contamination Control Regulatory Compliance Training - Live Webinars, Recordings & CDs

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
28
/ Jun
Friday-2019

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

  • Speaker: Charity Ogunsanya
  • Product ID: 703875
  • Duration: 90 Min
This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.
* Per Attendee
$249
The Regulatory Expectations for Environmental Monitoring Programs
25
/ Jul
Thursday-2019

The Regulatory Expectations for Environmental Monitoring Programs

  • Speaker: Kenneth Christie
  • Product ID: 703648
  • Duration: 90 Min
Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when auditing EM programs.
* Per Attendee
$249
Current Regulatory Requirements for Sterile Products
13
/ Aug
Tuesday-2019

Current Regulatory Requirements for Sterile Products

  • Speaker: Kenneth Christie
  • Product ID: 703672
  • Duration: 90 Min
This webinar will highlight and summarize the main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.
* Per Attendee
$249
Understanding Aseptic Technique and Cleanroom Behavior
14
/ Aug
Wednesday-2019

Understanding Aseptic Technique and Cleanroom Behavior

  • Speaker: Danielle DeLucy
  • Product ID: 704429
  • Duration: 60 Min
This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.
* Per Attendee
$229
Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
27
/ Aug
Tuesday-2019

Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

  • Speaker: Kenneth Christie
  • Product ID: 703635
  • Duration: 90 Min
This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.
* Per Attendee
$249
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
12
/ Sep
Thursday-2019

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

  • Speaker: Charity Ogunsanya
  • Product ID: 703885
  • Duration: 90 Min
This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.
* Per Attendee
$249
Recorded/CD
Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

  • Speaker: Joy McElroy
  • Product ID: 705929
  • Duration: 90 Min
In this cleaning validation webinar attendees will learn the Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.
CD/Recorded
$299
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
Understanding and Controlling Endotoxin in Water Systems

Understanding and Controlling Endotoxin in Water Systems

  • Speaker: T.C Soli
  • Product ID: 701301
  • Duration: 60 Min
This Water system compliance training cover all these issues and more so that the attendee can have a better appreciation of the endotoxin test, a better understanding of what can go wrong in WFI systems to allow endotoxin into the finished water.
CD/Recorded
$249
Recorded/CD
Water System Investigation "How-To's" and Example Case Studies

Water System Investigation "How-To's" and Example Case Studies

  • Speaker: T.C Soli
  • Product ID: 701585
  • Duration: 90 Min
In this Water System Webinar the author will explain the process he uses as a consultant for investigating and solving water system or product contamination problems with water organisms. Case studies of real life problems he has resolved will be presented to illustrate the process.
CD/Recorded
$249
Recorded/CD
Remediating Water System Biofilm - What to Do After It Gets Ahead of You

Remediating Water System Biofilm - What to Do After It Gets Ahead of You

  • Speaker: T.C Soli
  • Product ID: 702860
  • Duration: 90 Min
This pharmaceutical water systems webinar training will discuss what you should do when your monitoring data tells you that you may have a significant biofilm problem. It covers how to verify that the data and your interpretation of the data are correct, as well as the location of the problem which gives you clues as to what caused the problem and its impact on manufacturing and product.
CD/Recorded
$249
Recorded/CD
Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations

Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations

  • Speaker: Jim Polarine
  • Product ID: 701766
  • Duration: 90 Min
This webinar on addressing fungal and bacterial spore outbreaks will discuss case studies on excursion investigations and show how facility design, personnel practices and cleaning and disinfection effect excursion investigations.
CD/Recorded
$229
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
Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Operations

Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Operations

  • Speaker: Jim Polarine
  • Product ID: 701022
  • Duration: 90 Min
This webinar will discuss the details of specific excursion investigation for outbreaks of molds, vegetative bacteria, and Bacillus.
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
Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

  • Speaker: Henry Urbach
  • Product ID: 703474
  • Duration: 90 Min
This webinar will enable participants to understand sources of contamination and to investigate various contamination issues in the biopharmaceutical manufacturing of sterile and non-sterile products. Learn how to create an effective Environmental Monitoring (EM) program.
CD/Recorded
$249
Recorded/CD
Contamination Control in Pharmaceutical, Biotech and Medical Device Cleanroom

Contamination Control in Pharmaceutical, Biotech and Medical Device Cleanroom

  • Speaker: Jim Polarine
  • Product ID: 705078
  • Duration: 90 Min
This 90-minute webinar will cover general considerations for microbial control for non-sterile manufacturing areas, including attributes of an effective cleaning and disinfection program. Points to consider specifically aimed at oral solid dose (OSD) manufacturers will also be presented, including cleaning and disinfection of both product contact and non-product contact surfaces.
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.
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