ComplianceOnline
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
3
/ Feb
Monday-2020

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
Human Error Investigations, Root Cause Determination and CAPA Effectiveness
4
/ Feb
Tuesday-2020

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

  • Speaker: Ginette M Collazo
  • Product ID: 704314
  • Duration: 90 Min
This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.
* Per Attendee
$249
How low can you go? Different ways to determine the limit of detection
12
/ Feb
Wednesday-2020

How low can you go? Different ways to determine the limit of detection

  • Speaker: James Peterson
  • Product ID: 706251
  • Duration: 60 Min
This webinar will present and apply FBI, FDA and EPA approved methods for the determination of limits of detection (LOD) and limits of quantitation (LOQ) in chemical forensic and environmental analysis. These methods apply to most analytical techniques including gas and liquid chromatography, mass spectrometry, and elemental and molecular spectroscopy and can be used when analyzing blood, urine, food, or trace evidence for the presence of toxic chemicals or drugs.
* Per Attendee
$229
Validation of GC / GC-MS Methodologies
19
/ Feb
Wednesday-2020

Validation of GC / GC-MS Methodologies

  • Speaker: John Fetzer
  • Product ID: 705259
  • Duration: 60 Min
This training program will cover in detail the method validation of gas chromatography (GC) and gas chromatography mass spectrometry (GC-MS). It will focus on key elements of validation including injector, column, detection system, data system and much more.
* Per Attendee
$199
Improving GLP QA in the coming Decade
20
/ Feb
Thursday-2020

Improving GLP QA in the coming Decade

  • Speaker: Richard L Streeton
  • Product ID: 706355
  • Duration: 60 Min
QA groups in the pre-clinical space need to be the driver of change and improvement in their organization. In the coming decade the reliance on management to be a driver of change is no longer a held value. Senior management is looking to QA to be to set the tone for the organization and be the champion of the changing regulatory environment.
* Per Attendee
$229
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
20
/ Feb
Thursday-2020

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
Objectionable Microorganisms in Biopharmaceutical Manufacturing
21
/ Feb
Friday-2020

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.
* Per Attendee
$199
Starting a New Lab for Chemical Analysis
19
/ Mar
Thursday-2020

Starting a New Lab for Chemical Analysis

  • Speaker: James Peterson
  • Product ID: 706306
  • Duration: 60 Min
In this webinar the presenter will draw upon his experience in starting new private, contract research, state and federal government laboratories and laboratory subdivisions to elaborate the numerous aspects of developing a plan to open a new analytical lab for business in a reasonable amount of time.
* Per Attendee
$229
Sterilization of Pharmaceutical Products and Medical Devices
27
/ Mar
Friday-2020

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. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.
* Per Attendee
$229
How to Prepare a Standard Operating Procedure (SOP)?
27
/ Mar
Friday-2020

How to Prepare a 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.
* Per Attendee
$229
Basic Laboratory Skills
6
/ Apr
Monday-2020

Basic Laboratory Skills

  • Speaker: Mark Powell
  • Product ID: 706286
  • Duration: 60 Min
Accurate measurement of weight and correct use of volumetric apparatus are prerequisites for valid analytical measurement. This webinar covers the quality-critical aspects of both. It is intended for new starters in industrial analytical laboratories or for other staff who would benefit from refresher training.
* Per Attendee
$229
Handling OOS Test Results and Completing Robust Investigations
9
/ Apr
Thursday-2020

Handling OOS Test Results and Completing Robust Investigations

  • Speaker: Danielle DeLucy
  • Product ID: 704351
  • Duration: 90 Min
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
* Per Attendee
$249
Implementation and Management of GMP Data Integrity
18
/ Jun
Thursday-2020

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.
* Per Attendee
$249
Recorded/CD
Instrument Calibration for Chemical Forensic and Environmental Analysis

Instrument Calibration for Chemical Forensic and Environmental Analysis

  • Speaker: James Peterson
  • Product ID: 706289
  • Duration: 60 Min
This webinar will present approaches to instrument calibration that are used by FBI, FDA and EPA in forensic and environmental analysis. It will emphasize the importance of calibration in obtaining accurate results in analysis of trace evidence, toxicological specimens and environmental samples.
Recorded/CD
Good Documentation Guideline (Chapter <1029> USP)

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
CD/Recorded
$299
Recorded/CD
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

  • Speaker: Ginette M Collazo
  • Product ID: 704210
  • Duration: 60 Min
This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.
CD/Recorded
$299
Recorded/CD
Automating Assays for Clinical Diagnostics

Automating Assays for Clinical Diagnostics

  • Speaker: Todd Graham
  • Product ID: 703268
  • Duration: 60 Min
This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.
Recorded/CD
FDA's Ambitious Regulation of Social Media

FDA's Ambitious Regulation of Social Media

  • Speaker: Casper Uldriks
  • Product ID: 703853
  • Duration: 60 Min
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
CD/Recorded
$279
Recorded/CD
Product Stability Testing Program - Designing and Sustaining New and Existing Programs

Product Stability Testing Program - Designing and Sustaining New and Existing Programs

  • Speaker: Charity Ogunsanya
  • Product ID: 703000
  • Duration: 90 Min
This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.
CD/Recorded
$299
Recorded/CD
Laboratory Accreditation (ISO/IEC 17025): Everything Old is New Again

Laboratory Accreditation (ISO/IEC 17025): Everything Old is New Again

  • Speaker: Michael Brodsky
  • Product ID: 705272
  • Duration: 60 Min
This training program will discuss in details the new requirements of ISO/IEC 17015:2017 laboratory accreditation standard and their impact on quality management system. It will provide you with an overview of the salient differences and similarities between the old and the new standard and provide advice on what you must do to meet the requirements each of the elements.
CD/Recorded
$229
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