ComplianceOnline

Regulations & Guidances Compliance Training - Live Webinars, Recordings & CDs

Understanding and Implementing a Quality by Design (QbD) Program
22
/ Jan
Wednesday-2020

Understanding and Implementing a Quality by Design (QbD) Program

  • Speaker: Steven Laurenz
  • Product ID: 705001
  • Duration: 60 Min
This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.
* Per Attendee
$229
Good Documentation Guideline (Chapter <1029> USP)
22
/ Jan
Wednesday-2020

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
Understanding the FDA Compounding Pharmacies Guidance
24
/ Jan
Friday-2020

Understanding the FDA Compounding Pharmacies Guidance

  • Speaker: Carl Patterson
  • Product ID: 705348
  • Duration: 60 Min
This webinar will cover in detail the FDA Compounding Pharmacies Guidance and will review the Aseptic Guidance document. It will help Compounding Pharmacies understand what actions are needed in order to prevent insanitary conditions.
* Per Attendee
$179
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
Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities
5
/ Feb
Wednesday-2020

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

  • Speaker: Vanessa Lopez
  • Product ID: 704758
  • Duration: 90 Min
This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.
* Per Attendee
$249
How to Conduct Annual Product Reviews to Achieve GMP Compliance Annual
14
/ Feb
Friday-2020

How to Conduct Annual Product Reviews to Achieve GMP Compliance Annual

  • 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
Japan: Regulatory Compliance Requirements for Life Science Products
19
/ Feb
Wednesday-2020

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
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
Understanding and Implementing a Technology Transfer Process
27
/ Feb
Thursday-2020

Understanding and Implementing a Technology Transfer Process

  • Speaker: Steven Laurenz
  • Product ID: 705031
  • Duration: 60 Min
This webinar will discuss the steps to guide the technology transfer for the successful implementation, ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.
* Per Attendee
$229
Steam Sterilization Microbiology and Autoclave Performance Qualification
9
/ Mar
Monday-2020

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
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
FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products
31
/ Mar
Tuesday-2020

FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

  • Speaker: Carolyn Troiano
  • Product ID: 705097
  • Duration: 90 Min
This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.
* Per Attendee
$249
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
4-Hr Virtual Training: How to Respond to an FDA Investigation

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.
CD/Recorded
$449
Recorded/CD
Annual Current Good Manufacturing Practices (cGMP) Training

Annual Current Good Manufacturing Practices (cGMP) Training

  • Speaker: Kelly Thomas
  • Product ID: 705422
  • Duration: 60 Min
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
CD/Recorded
$249
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
Best Practices for an Effective Cleaning Validation Program

Best Practices for an Effective Cleaning Validation Program

  • Speaker: Joy McElroy
  • Product ID: 704329
  • Duration: 60 Min
This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.
CD/Recorded
$299
Best Sellers
You Recently Viewed
    Loading