ComplianceOnline

Medical Device Supply Chain and Manufacturing Regulatory Compliance Training - Live Webinars, Recordings & CDs

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
28
/ Jun
Friday-2019

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.
* Per Attendee
$249
Implementation and Management of GMP Data Integrity
3
/ Jul
Wednesday-2019

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. Also attendees will examples of data integrity pitfalls, • part 11 compliance data integrity issues, FDA citations related to data integrity and how to improve data integrity in a laboratory environment.
* Per Attendee
$249
The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016
9
/ Jul
Tuesday-2019

The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016

  • Speaker: John E Lincoln
  • Product ID: 705111
  • Duration: 90 Min
This webinar will focus on the IEC standard and its key requirements: “IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices”. It will touch on “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”. Another webinar will focus on Part 2, and re-evaluate key portions of Part-1.
* Per Attendee
$249
Challenges of an Effective Change Control Program
10
/ Jul
Wednesday-2019

Challenges of an Effective Change Control Program

  • Speaker: Kenneth Christie
  • Product ID: 704638
  • Duration: 90 Min
This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.
* Per Attendee
$249
How to Prepare a Standard Operating Procedure (SOP)?
11
/ Jul
Thursday-2019

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
$229
Process Validation - Overview of Why and How
24
/ Jul
Wednesday-2019

Process Validation - Overview of Why and How

  • Speaker: Betty Lane
  • Product ID: 703520
  • Duration: 60 Min
This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.
* Per Attendee
$199
Current Regulatory Requirements for Sterile Products
13
/ Aug
Tuesday-2019

Current Regulatory Requirements for Sterile Products

  • Speaker: Kenneth Christie
  • Product ID: 703672
  • Duration: 90 Min
This webinar will highlight and summarize the main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.
* Per Attendee
$249
CGMP controlled Raw Materials
15
/ Aug
Thursday-2019

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
Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
27
/ Aug
Tuesday-2019

Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

  • Speaker: Kenneth Christie
  • Product ID: 703635
  • Duration: 90 Min
This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.
* Per Attendee
$249
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
12
/ Sep
Thursday-2019

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
How to Investigate Environmental Monitoring Excursions
17
/ Sep
Tuesday-2019

How to Investigate Environmental Monitoring Excursions

  • Speaker: Gerry O Dell
  • Product ID: 701354
  • Duration: 90 Min
This OOS investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions.
* Per Attendee
$199
Project Management for FDA-Regulated Companies
18
/ Sep
Wednesday-2019

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.
* Per Attendee
$229
Recorded/CD
A Bulletproof, Cost-Efficient Supplier Management Program

A Bulletproof, Cost-Efficient Supplier Management Program

  • Speaker: Jeff Kasoff
  • Product ID: 700193
  • Duration: 60 Min
Attend this webinar to learn the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation, including “critical” suppliers and outsourced processes. Also attendees will learn QSR and ISO requirements for supplier assessment and the application of a risk-based process resulting in a customized supplier management system.
CD/Recorded
$299
Recorded/CD
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

  • Speaker: Robert J Russell
  • Product ID: 701369
  • Duration: 90 Min
This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
CD/Recorded
$249
Recorded/CD
Supplier and Service Provider Controls: FDA Expectations

Supplier and Service Provider Controls: FDA Expectations

  • Speaker: Vanessa Lopez
  • Product ID: 704844
  • Duration: 120 Min
This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
CD/Recorded
$349
Recorded/CD
Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers

Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers

  • Speaker: Betty Lane
  • Product ID: 702502
  • Duration: 75 Min
This webinar will provide you the information you need to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet expectations of the FDA and ISO 13485 Notified Body auditors.
CD/Recorded
$249
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
Creating a Risk-based Supplier Management program

Creating a Risk-based Supplier Management program

  • Speaker: Betty Lane
  • Product ID: 702501
  • Duration: 75 Min
This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest FDA, European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while potentially reducing your cost of compliance.
CD/Recorded
$299
Recorded/CD
ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements?

ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements?

  • 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 14971:2012 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
Process Challenge Device Development for EO Sterilization

Process Challenge Device Development for EO Sterilization

  • Speaker: Gerry O Dell
  • Product ID: 703443
  • Duration: 90 Min
This webinar will discuss the role of Process Challenge Devices (PCDs) both during ethylene oxide (EO) validation and during routine processing. It will explain the difference in requirements for PCD during both the processes.
CD/Recorded
$299
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