ComplianceOnline
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
4
/ May
Tuesday-2021

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
CGMP controlled Raw Materials
4
/ May
Tuesday-2021

CGMP controlled Raw Materials

  • Speaker: Charity Ogunsanya
  • Product ID: 705148
  • Duration: 90 Min
This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.
* Per Attendee
$249
Data Integrity Compliance for Computer Systems Regulated by FDA
11
/ May
Tuesday-2021

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.
* Per Attendee
$229
Statistical Elements of Small Sample Sizes and Only 3 Lots in Process or Product Validation
13
/ May
Thursday-2021

Statistical Elements of Small Sample Sizes and Only 3 Lots in Process or Product Validation

  • Speaker: Elaine Eisenbeisz
  • Product ID: 706635
  • Duration: 90 Min

Attendees of this webinar will learn statistically valid methods for using small sample sizes and for using lots as few as 3 when validating processes or products.
The focus of this webinar is on providing the information needed for attendees to understand the concepts of risk in relation to process validation and to be able to compute sample sizes and lot sizes according the desired or required specification criteria or the process or product.

* Per Attendee
$249
Good Documentation Guideline (Chapter <1029> USP)
18
/ May
Tuesday-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
$199
The 6 Most Common Problems in FDA Software Validation and Verification
18
/ May
Tuesday-2021

The 6 Most Common Problems in FDA Software Validation and Verification

  • Speaker: David Nettleton
  • Product ID: 705582
  • Duration: 120 Min
This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
* Per Attendee
$249
Structuring and Conducting Risk-Based Internal cGMP Compliance Audits
19
/ May
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
$199
How to write SOP's that Avoid Human Error
26
/ May
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
Root Cause Analysis - The Heart of Corrective Action
26
/ May
Wednesday-2021

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
21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
8
/ Jun
Tuesday-2021

21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures

  • Speaker: Carolyn Troiano
  • Product ID: 706563
  • Duration: 90 Min
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
* Per Attendee
$249
SaaS/Cloud Risk-Based Validation With Time-Saving Templates
10
/ Jun
Thursday-2021

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
Vendor Management for Pharmaceuticals, Biologicals, and Medical Devices
14
/ Jun
Monday-2021

Vendor Management for Pharmaceuticals, Biologicals, and Medical Devices

  • Speaker: Paul Larocque
  • Product ID: 706689
  • Duration: 90 Min
This webinar provides an overview of FDA’s requirements for vendor management and oversight for pharmaceuticals, biologicals, and medical devices.
* Per Attendee
$249
How to Prepare a Standard Operating Procedure (SOP)?
15
/ Jun
Tuesday-2021

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
$199
Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies
17
/ Jun
Thursday-2021

Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies

  • Speaker: Elaine Eisenbeisz
  • Product ID: 706650
  • Duration: 90 Min
This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the determining sample size and providing justification for the planned sample sizes.
* Per Attendee
$199
Writing and Revising SOPs for Increased Operational Efficiency
20
/ Jul
Tuesday-2021

Writing and Revising SOPs for Increased Operational Efficiency

  • Speaker: Rob MacCuspie
  • Product ID: 706214
  • Duration: 60 Min
This webinar will discuss how to more effectively write and revise standard operating procedures (SOPs) with a focus on increasing operational efficiencies.
* Per Attendee
$199
Recorded/CD
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

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.
CD/Recorded
$299
Recorded/CD
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

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.
CD/Recorded
$299
Recorded/CD
Is My Nanotechnology Safe? Approaches For NanoEHS Risk Assessments

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.
CD/Recorded
$299
Recorded/CD
Human Error Investigations, Root Cause Determination and CAPA Effectiveness

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.
CD/Recorded
$299
Recorded/CD
Management Controls Under QSR and ISO 13485

Management Controls Under QSR and ISO 13485

  • Speaker: Jeff Kasoff
  • Product ID: 700988
  • Duration: 60 Min
This session will discuss the requirements for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system.
CD/Recorded
$249
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