ComplianceOnline
Document Control and Change Control Process in GxP/GMP Environment
17
/ Jan
Friday-2020

Document Control and Change Control Process in GxP/GMP Environment

  • Speaker: Eleonora Babayants
  • Product ID: 705682
  • Duration: 90 Min
In this Gxp/GMP webinar, the connection between GxP/GMP and document control will be discussed. Details of document control procedures and the role of Quality Assurance in the documentation systems will be described as well as change control procedures for documentation.
* Per Attendee
$249
Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
22
/ Jan
Wednesday-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
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
The Mindset of an FDA Employee
27
/ Jan
Monday-2020

The Mindset of an FDA Employee

  • Speaker: Larry Stevens
  • Product ID: 706174
  • Duration: 60 Min
If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. It is important to interact with the FDA employee in the most productive manner. But there is a variable you must deal with that will determine how productive your interaction is. The variable is the FDA employee. That is the purpose of this webinar.
* Per Attendee
$229
Risk Management in Pharmaceuticals and BioTech
29
/ Jan
Wednesday-2020

Risk Management in Pharmaceuticals and BioTech

  • Speaker: Martin Lessem
  • Product ID: 706325
  • Duration: 90 Min
This course will focus on Risk Management in the Pharmaceutical and BioTech space. It will cover Risk Management Programs and also managing general regulatory risks in the drug development process.
* Per Attendee
$229
Developing a Strategic Approach to FDA Compliance for Computer Systems
29
/ Jan
Wednesday-2020

Developing a Strategic Approach to FDA Compliance for Computer Systems

  • Speaker: Carolyn Troiano
  • Product ID: 706124
  • Duration: 90 Min
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, which is critical in order to be able to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project that you may undertake, and the importance of the sequence of steps will also be covered, to ensure you are able to comply with FDA expectations.
* Per Attendee
$249
Practical Fundamentals for an Effective and Efficient On-the-Job Training Program
30
/ Jan
Thursday-2020

Practical Fundamentals for an Effective and Efficient On-the-Job Training Program

  • Speaker: Mike Kent
  • Product ID: 706324
  • Duration: 90 Min
This webinar will identify elements critical to both the compliance and effectiveness of an On-the-Job Training (OJT) program and provide practical strategies for implementing them efficiently and sustainably. Whether your training program is just getting started or is highly mature, the tools and ideas presented here will help you optimize its effectiveness while reducing compliance risk.
* Per Attendee
$249
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
Implementing a Robust Data Integrity Program
6
/ Feb
Thursday-2020

Implementing a Robust Data Integrity Program

  • Speaker: Kelly Thomas
  • Product ID: 706178
  • Duration: 90 Min
This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems. It will cover the common problems from FDA 483 observations and warning letters and teach you how to avoid them.
* Per Attendee
$249
Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry
6
/ Feb
Thursday-2020

Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry

  • Speaker: Robert J Russell
  • Product ID: 702038
  • Duration: 90 Min
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
* Per Attendee
$249
Occupational Safety of Nanomaterials
11
/ Feb
Tuesday-2020

Occupational Safety of Nanomaterials

  • Speaker: Rob MacCuspie
  • Product ID: 706203
  • Duration: 60 Min
This webinar will discuss how to use tiered approaches to evaluate the occupational safety risks of nanomaterials handling and processing for both laboratory environments and production environments, as well as common risk mitigation approaches.
* Per Attendee
$229
FDA Inspections: Understanding the Core Elements – Part I
12
/ Feb
Wednesday-2020

FDA Inspections: Understanding the Core Elements – Part I

  • Speaker: Vanessa Lopez
  • Product ID: 706256
  • Duration: 120 Min
Attend this course to learn the rationale, strategies and flow on how to plan for an FDA inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
* Per Attendee
$299
Good Documentation Practice (GDocP) for FDA Regulated Industry
12
/ Feb
Wednesday-2020

Good Documentation Practice (GDocP) for FDA Regulated Industry

  • Speaker: Eleonora Babayants
  • Product ID: 705782
  • Duration: 90 Min
This good documentation practice webinar will discuss how to secure, manage and govern your documentation in compliance with GxP/GMP requirements and be able to pass quality audit. Also attendees will learn the connection between CxP/GMP and document control, which documents need to be controlled and which are not, what documentation required for QMS, how QA can plays an important role in documentation systems and how change control procedure used in GxP/GMP environment.
* Per Attendee
$199
Recorded/CD
Making Data Driven Decisions using Statistical Hypothesis Testing

Making Data Driven Decisions using Statistical Hypothesis Testing

  • Speaker: Steven Wachs
  • Product ID: 704211
  • Duration:
This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes. Several types of hypothesis tests will be covered such as 1 and 2-sample means tests, tests of variances, and tests of proportions. Equivalence tests will also be discussed. The importance of selecting appropriate sample sizes will be stressed.
CD/Recorded
$299
Recorded/CD
3-Hr Virtual Training: Introduction to Design of Experiments

3-Hr Virtual Training: Introduction to Design of Experiments

  • Speaker: Steven Wachs
  • Product ID: 704847
  • Duration: 3 hrs
In this training program, attendees will understand when and why to apply DOE (design of experiments). They will also learn to identify and interpret significant factor effects and 2-factor interactions and develop predictive models to explain and optimize process/product behavior. Applying efficient fractional factorial designs in screening experiments will also be discussed.
CD/Recorded
$449
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
How to Develop, Implement and Manage an Effective Change Control Program

How to Develop, Implement and Manage an Effective 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
Sample Size Determination for Design Validation Activities

Sample Size Determination for Design Validation Activities

  • Speaker: Steven Wachs
  • Product ID: 705852
  • Duration: 90 Min
Statistical Methods are typically used to ensure that product performance, quality, and reliability requirements are met during the Design Validation phase of product development. This webinar discusses common elements of sample size determination and several specific sample size applications for various design validation activities including Reliability Demonstration/Estimation, Acceptance Sampling, and Hypothesis Testing.
CD/Recorded
$299
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