ComplianceOnline
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
Enhance ISO 9001:2015 with Features from IATF 16949:2016
1
/ Dec
Tuesday-2020

Enhance ISO 9001:2015 with Features from IATF 16949:2016

  • Speaker: William Levinson
  • Product ID: 706581
  • Duration: 60 Min
IATF 16949:2016 consists of ISO 9001:2015 plus additional requirements for automotive suppliers, and many of these features have universal as opposed to automotive-specific applications. ISO 9001 users can benefit by adding them to their own quality systems as well.
* Per Attendee
$329
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
Labeling, Advertising and Promotion in the Regulated Environment
7
/ Dec
Monday-2020

Labeling, Advertising and Promotion in the Regulated Environment

  • Speaker: Susanne Steiner
  • Product ID: 706586
  • Duration: 90 Min
Labeling, Advertising and Promotion of drugs, biologics and medical devices are heavily regulated and aggressively reviewed on behalf of the regulators such as FDA, FTC and other Federal Authorities. This course provides an overview of label development, building a Target Product Profile, the label’s impact on advertising and promotion, and recent changes in how these areas are monitored and enforced.
* Per Attendee
$349
Is My Nanotechnology Safe? Approaches For NanoEHS Risk Assessments
7
/ Dec
Monday-2020

Is My Nanotechnology Safe? Approaches For NanoEHS Risk Assessments

  • Speaker: Rob MacCuspie
  • Product ID: 706181
  • Duration: 60 Min
This webinar will discuss how to use tiered approaches to evaluate the benefits and risks of novel nanomaterials and product formulations containing nanomaterials, as well as common risk mitigation approaches.
* Per Attendee
$229
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
Medical Device Cybersecurity and FDA Compliance
10
/ Dec
Thursday-2020

Medical Device Cybersecurity and FDA Compliance

  • Speaker: Carolyn Troiano
  • Product ID: 706169
  • Duration: 90 Min
In this webinar, you will learn just how cyberattacks threaten medical devices and how industry is currently responding to them. We will discuss the many ways of preventing and mitigating the cybersecurity risk, and about the industry best practices that can help your company do the same.
* Per Attendee
$249
Aseptic Processing Overview and Validation
15
/ Dec
Tuesday-2020

Aseptic Processing Overview and Validation

  • Speaker: Kelly Thomas
  • Product ID: 706212
  • Duration: 90 Min
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
* Per Attendee
$249
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
21 CFR Part 11 and QMS Software Risk-Based Implementation
16
/ Dec
Wednesday-2020

21 CFR Part 11 and QMS Software Risk-Based Implementation

  • Speaker: John E Lincoln
  • Product ID: 706363
  • Duration: 60 Min
CGMP-compliant companies must develop / implement formal software controls and usage, starting with proper verification and validation methods. This is an important consideration for a company’s Quality Management System (QMS) and must consider applicable elements of electronic records / signatures / Part 11. The US FDA recently added data integrity and cybersecurity to these requirements. These activities must be properly documented.
* Per Attendee
$229
Implementing a Robust Supplier Management Program
16
/ Dec
Wednesday-2020

Implementing a Robust Supplier Management Program

  • Speaker: Kelly Thomas
  • Product ID: 706055
  • Duration: 90 Min
This course will review regulatory guidance governing Suppliers and the elements of a robust supplier management program including, initial qualification, supplier performance monitoring, and scorecards, supplier audit options, and quality agreement requirements. It will discuss how to utilize risk-based quality tools to determine supplier classification with a risk assessment example. Recent FDA audit findings will also be reviewed.
* 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
Assess Impact For Supplier Change Notices
12
/ Jan
Tuesday-2021

Assess Impact For Supplier Change Notices

  • Speaker: Alan M Golden
  • Product ID: 706344
  • Duration: 60 Min
This webinar will discuss dealing with supplier change notices. Regulatory agencies have the expectation that a manufacturer has control over its supply chain and dealing with changes to that supply chain can be challenging.
* Per Attendee
$229
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
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
Data Integrity Compliance for Computer Systems Regulated by FDA

Data Integrity Compliance for Computer Systems Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 706352
  • Duration: 90 Min
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. In this webinar, you will learn about these FDA trends in compliance and enforcement, as they relate to data integrity, and how to improve your practices to meet compliance requirements.
CD/Recorded
$299
Recorded/CD
EO Sterilization Equipment, Software and Product Validation Per ISO 11135

EO Sterilization Equipment, Software and Product Validation Per ISO 11135

  • Speaker: John E Lincoln
  • Product ID: 706566
  • Duration: 60 Min
ISO 11135:2014: “Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices”, defines the latest requirements for the validation of Ethylene Oxide sterilization of medical devices, the sterilization chamber, and sterilization controls. This webinar will use ISO 11135 as a basis for a field-tested approach to sterilization validation and its documentation, including the chamber control software.
CD/Recorded
$299
Recorded/CD
Implementing a Robust and Compliant Change Control Program

Implementing a Robust and Compliant Change Control Program

  • Speaker: Kelly Thomas
  • Product ID: 705909
  • Duration: 90 Min
This Change Control training program will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough Change Control program; as well as, discuss the elements regarding successful management an effective Change Control system.
CD/Recorded
$299
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
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