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Home › Online Training ›  Biotechnology Training

Biotech Regulatory Compliance Training - Live Webinars, Recordings & CDs

Sub Categories: Testing and Validation | Documentation and IT | Contamination Control | Quality & Safety | Technologies and Processes | Blood and Blood Products | Tissue and Tissue Products | Cellular and Gene Therapy | Biologics and Biosimilars | Regulations & Guidances
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Japan: Regulatory Compliance Requirements for Life Science Products
23
/ Aug
Friday-2019

Japan: Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 702979
  • Duration: 90 Min
This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
* Per Attendee
$249
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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
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Proper Execution of Annual Product Reviews
5
/ Sep
Thursday-2019

Proper Execution of Annual Product Reviews

  • Speaker: Danielle DeLucy
  • Product ID: 704993
  • Duration: 60 Min
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.
* Per Attendee
$229
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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
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Steam Sterilization Microbiology and Autoclave Performance Qualification
16
/ Sep
Monday-2019

Steam Sterilization Microbiology and Autoclave Performance Qualification

  • Speaker: Danielle DeLucy
  • Product ID: 705027
  • Duration: 60 Min
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
* Per Attendee
$229
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FDA's Ambitious Regulation of Social Media
24
/ Sep
Tuesday-2019

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.
* Per Attendee
$229
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Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
8
/ Oct
Tuesday-2019

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

  • Speaker: Joy McElroy
  • Product ID: 704531
  • Duration: 120 Min
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.
* Per Attendee
$299
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Root Cause Analysis - The Heart of Corrective Action
8
/ Oct
Tuesday-2019

Root Cause Analysis - The Heart of Corrective Action

  • Speaker: Betty Lane
  • Product ID: 703391
  • Duration: 75 Min
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
* Per Attendee
$229
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Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971
9
/ Oct
Wednesday-2019

Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971

  • Speaker: Tanvir Mahmud
  • Product ID: 702422
  • Duration: 90 Min
This 90-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.
* Per Attendee
$249
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Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
24
/ Oct
Thursday-2019

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

  • Speaker: Joy McElroy
  • Product ID: 704086
  • Duration: 120 Min
The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
* Per Attendee
$299
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Good Documentation Guideline (Chapter <1029> USP)
24
/ Oct
Thursday-2019

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.
* Per Attendee
$229
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How to Prepare a Standard Operating Procedure (SOP)?
19
/ Nov
Tuesday-2019

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
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4-Hr Virtual Training: How to Respond to an FDA Investigation
4
/ Dec
Wednesday-2019

4-Hr Virtual Training: How to Respond to an FDA Investigation

  • Speaker: Joy McElroy
  • Product ID: 704549
  • Duration: 4 hrs
This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.
* Per Attendee
$399
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Handling OOS Test Results and Completing Robust Investigations
17
/ Dec
Tuesday-2019

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
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Recorded/CD
CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

  • Speaker: Sunil Gupta
  • Product ID: 704316
  • Duration: 90 Min
This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide effective and practical solutions to address real-world issues.
CD/Recorded
$299
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Recorded/CD
CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

  • Speaker: Sunil Gupta
  • Product ID: 704313
  • Duration: 90 Min
This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.
CD/Recorded
$299
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Recorded/CD
Understanding Aseptic Technique and Cleanroom Behavior

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.
CD/Recorded
$299
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Recorded/CD
Combination Drug/Device Products CGMPs - Final Rule

Combination Drug/Device Products CGMPs - Final Rule

  • Speaker: John E Lincoln
  • Product ID: 702810
  • Duration: 90 Min
This training on combination product regulations will evaluate the chief areas of concern or change in the new CGMP requirements for combination products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving combination products.
CD/Recorded
$299
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Recorded/CD
How to write SOP's that Avoid Human Error

How to write SOP's that Avoid Human Error

  • Speaker: Ginette M Collazo
  • Product ID: 704418
  • Duration: 90 Min
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
CD/Recorded
$299
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Recorded/CD
Bioanalytical Methods Validation

Bioanalytical Methods Validation

  • Speaker: Edward O Connor
  • Product ID: 701769
  • Duration: 60 Min
This training on bio-analytical methods validation will help you understand the clear, consistent and compliant approaches for instrumental, ligand binding, and cell based methods. A comparison of EMEA and FDA guidances will be presented.
CD/Recorded
$299
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