ComplianceOnline
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
The FDA Inspection: Best Practices for Preparation, Management, and Follow-Up
18
/ Jun
Friday-2021

The FDA Inspection: Best Practices for Preparation, Management, and Follow-Up

  • Speaker: Jeff Kasoff
  • Product ID: 701568
  • Duration: 60 Min
This course provides medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
* Per Attendee
$199
Cybersecurity and US FDA Requirements
30
/ Jun
Wednesday-2021

Cybersecurity and US FDA Requirements

  • Speaker: John E Lincoln
  • Product ID: 706716
  • Duration: 60 Min
Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information.
* Per Attendee
$199
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
7
/ Jul
Wednesday-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
FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance
13
/ Jul
Tuesday-2021

FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance

  • Speaker: Carolyn Troiano
  • Product ID: 706561
  • Duration: 90 Min
As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed to assure data integrity is maintained. This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.
* Per Attendee
$249
Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention
13
/ Jul
Tuesday-2021

Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention

  • Speaker: Jeff Kasoff
  • Product ID: 700986
  • Duration: 60 Min
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! In this webinar, learn the best practices for managing complaints.
* Per Attendee
$199
Human Error Reduction in GMP Manufacturing
13
/ Jul
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
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
The 6 Most Common Problems in FDA Software Validation and Verification
28
/ Jul
Wednesday-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
SaaS/Cloud Risk-Based Validation With Time-Saving Templates
18
/ Aug
Wednesday-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
Data Integrity Compliance for Computer Systems Regulated by FDA
26
/ Aug
Thursday-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
Recorded/CD
Report Writing for Auditing Professionals

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.
CD/Recorded
$249
Recorded/CD
21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures

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.
CD/Recorded
$299
Recorded/CD
How to write SOP's that Avoid Human Error

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.
CD/Recorded
$299
Recorded/CD
Root Cause Analysis - The Heart of Corrective Action

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.
CD/Recorded
$299
Recorded/CD
Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

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.
CD/Recorded
$299
Recorded/CD
Good Documentation Guideline (Chapter <1029> USP)

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.
CD/Recorded
$299
Recorded/CD
Statistical Elements of Small Sample Sizes and Only 3 Lots in Process or Product Validation

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.

CD/Recorded
$299
Recorded/CD
CGMP controlled Raw Materials

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.
CD/Recorded
$399
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