ComplianceOnline

Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
24
/ Nov
Tuesday-2020

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

  • Speaker: David Nettleton
  • Product ID: 701582
  • Duration: 75 Min
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
* Per Attendee
$229
Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
1
/ Dec
Tuesday-2020

Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements

  • Speaker: John E Lincoln
  • Product ID: 700149
  • Duration: 60 Min
In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested field-tested individual V&V plans, Test Report / Protocol formats, and individual test cases, IQ, OQ, and PQs, are presented.
* Per Attendee
$229
Annual Current Good Manufacturing Practices (cGMP) Training
3
/ Dec
Thursday-2020

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.
* Per Attendee
$199
FDA's Ambitious Regulation of Social Media
10
/ Dec
Thursday-2020

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
How To Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities
15
/ Dec
Tuesday-2020

How To Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities

  • Speaker: Javier Kuong
  • Product ID: 700095
  • Duration: 120 Min
This training will provide valuable knowledge on what companies need to do to establish an "effective" Compliance Office that leads to conceiving, developing and implementing successful GRC programs and provides top level coordinating leadership for governance, risk management and compliance issues across the enterprise.
* Per Attendee
$199
SaaS/Cloud Risk-Based Validation With Time-Saving Templates
16
/ Dec
Wednesday-2020

SaaS/Cloud Risk-Based Validation With Time-Saving Templates

  • Speaker: David Nettleton
  • Product ID: 701687
  • Duration: 90 Min
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
* Per Attendee
$249
Human Error Reduction in GMP Manufacturing
12
/ Jan
Tuesday-2021

Human Error Reduction in GMP Manufacturing

  • Speaker: Ginette M Collazo
  • Product ID: 704107
  • Duration: 90 Min
This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.
* Per Attendee
$249
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
13
/ Jan
Wednesday-2021

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705583
  • Duration: 60 Min
In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.
* Per Attendee
$229
How to write SOP's that Avoid Human Error
27
/ Jan
Wednesday-2021

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.
* Per Attendee
$249
Structuring and Conducting Risk-Based Internal cGMP Compliance Audits
3
/ Feb
Wednesday-2021

Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

  • Speaker: John E Lincoln
  • Product ID: 701432
  • Duration: 60 Min
This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.
* Per Attendee
$229
Report Writing for Auditing Professionals
9
/ Feb
Tuesday-2021

Report Writing for Auditing Professionals

  • Speaker: Phil Vassallo
  • Product ID: 703814
  • Duration: 90 Min
Skilled auditors require a method that aligns what they experienced during the reviewing process with what they compose during the writing process. This report writing workshop will provide foundation resources that participants can continually turn to during intense, complex audit engagements.
* Per Attendee
$199
Good Documentation Guideline (Chapter <1029> USP)
10
/ Feb
Wednesday-2021

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
Recorded/CD
Properly Investigating and Remediating OOS Results

Properly Investigating and Remediating OOS Results

  • 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.
CD/Recorded
$299
Recorded/CD
Veterinary Medical Devices and FDA’s Regulatory Oversight

Veterinary Medical Devices and FDA’s Regulatory Oversight

  • Speaker: Karl M. Nobert
  • Product ID: 703769
  • Duration: 60 Min
This webinar will make your understand regulatory requirements of veterinary medical device. How to differentiate regulations of human and veterinary medical devices, manufacturing requirements, safety standards, labelling requirements, how to draft the SOPs covering material intake, production, quality control, packing, distribution and sales.
CD/Recorded
$399
Recorded/CD
How to Conduct Successful Supplier Audits

How to Conduct Successful Supplier Audits

  • Speaker: Danielle DeLucy
  • Product ID: 704499
  • Duration: 60 Min
This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.
CD/Recorded
$249
Recorded/CD
Proper Handling of OOT and OOS Results

Proper Handling of OOT and OOS Results

  • Speaker: Kelly Thomas
  • Product ID: 702540
  • Duration: 90 Min
This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA compliant documentation of OOT, failure investigations, root causes and CAPA.
CD/Recorded
$299
Recorded/CD
An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use

An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use

  • Speaker: Karl M. Nobert
  • Product ID: 701927
  • Duration: 90 Min
This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
CD/Recorded
$399
Recorded/CD
FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

  • Speaker: Danielle DeLucy
  • Product ID: 704659
  • Duration: 60 Min
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
CD/Recorded
$299
Recorded/CD
Implementation and Management of GMP Data Integrity

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.
CD/Recorded
$299
Recorded/CD
How to Investigate Environmental Monitoring Excursions

How to Investigate Environmental Monitoring Excursions

  • Speaker: Gerry O Dell
  • Product ID: 701354
  • Duration: 90 Min
This environmental excursion investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions.
CD/Recorded
$249
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