ComplianceOnline

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

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
$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
$199
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
$199
Report Writing for Auditing Professionals
9
/ Jun
Wednesday-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
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
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
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
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
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
Recorded/CD
Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance

Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance

  • Speaker: Jeff Kasoff
  • Product ID: 701142
  • Duration: 60 Min
This Quality management training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive Maintenance.
CD/Recorded
$249
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
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
ISO 14971:2019 - Does your Risk Analysis meet this new revision of the Standard?

ISO 14971:2019 - Does your Risk Analysis meet this new revision of the Standard?

  • Speaker: Betty Lane
  • Product ID: 702871
  • Duration: 60 Min
This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2019 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.
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
Recorded/CD
Project Management for FDA-Regulated Companies

Project Management for FDA-Regulated Companies

  • Speaker: John E Lincoln
  • Product ID: 701758
  • Duration: 60 Min
This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.
CD/Recorded
$299
Recorded/CD
Quality Control of Microbiological Media, Reagents and Test Kits

Quality Control of Microbiological Media, Reagents and Test Kits

  • Speaker: Michael Brodsky
  • Product ID: 703599
  • Duration: 60 Min
The webinar will discuss QC best practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents.
CD/Recorded
$249
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