ComplianceOnline
Sterilization of Pharmaceutical Products and Medical Devices
20
/ Aug
Tuesday-2019

Sterilization of Pharmaceutical Products and Medical Devices

  • Speaker: Carl Patterson
  • Product ID: 705310
  • Duration: 60 Min
This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.
* Per Attendee
$229
Supplier Management with the new Medical Device Regulation EU MDR 745/2017
20
/ Aug
Tuesday-2019

Supplier Management with the new Medical Device Regulation EU MDR 745/2017

  • Speaker: Frank Stein
  • Product ID: 706068
  • Duration: 90 Min
In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.
* Per Attendee
$249
Process Validation - Overview of Why and How
20
/ Aug
Tuesday-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
Risk-based Design Control - The New Paradigm for Medical Device Design
20
/ Aug
Tuesday-2019

Risk-based Design Control - The New Paradigm for Medical Device Design

  • Speaker: Jose Mora
  • Product ID: 706095
  • Duration: 60 Min
In this webinar, learn about the 2019 approach to compliant design control, how to create, manage, and maintain the information found in the various Risk Management documents and files. Get insights about how to shrink documentation time to provide enough time for actual risk management and mitigation.
* Per Attendee
$229
Health Canada Medical Device Regulations (SOR/98-202)
22
/ Aug
Thursday-2019

Health Canada Medical Device Regulations (SOR/98-202)

  • Speaker: Winkie Wong
  • Product ID: 706126
  • Duration: 90 Min
Attend this webinar to get an overview of the Health Canada Medical Devices Regulations and its requirements. Also, get guidance on how to approach MDEL and Device Licensing, Renewals and Costs.
* Per Attendee
$249
Statistical Justification for Using Small Sample Sizes and only 3 Lots in Process or Product Validation
22
/ Aug
Thursday-2019

Statistical Justification for Using Small Sample Sizes and only 3 Lots in Process or Product Validation

  • Speaker: John N Zorich
  • Product ID: 705980
  • Duration: 90 Min
In this webinar attendees will learn a statistically valid method for justification of small sample sizes for use in product or process validation studies (e.g. performed during design verification phase of design control). A different method will be explained for how to statistically justify the number of lots or batches used in such studies, a number that can be as low as 3.
* Per Attendee
$249
Japan: Regulatory Compliance Requirements for Life Science Products
23
/ Aug
Friday-2019

Japan: Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 702979
  • Duration: 90 Min
This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
* Per Attendee
$249
State of the Art: Recommendations for writing a thorough SOA and build SOA Libraries for your CERs
27
/ Aug
Tuesday-2019

State of the Art: Recommendations for writing a thorough SOA and build SOA Libraries for your CERs

  • Speaker: Maria Sanchez
  • Product ID: 706081
  • Duration: 90 Min
This webinar will showcase the importance of State of the Art in Clinical Evaluation Reports for Medical Devices and provide tools and recommendations for writing a well-structured SOA setting the stage for the entire CER. The webinar will also provide recommendations to build a State-of-the-Art Library for your medical device portfolio.
* 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
ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements?
28
/ Aug
Wednesday-2019

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.
* Per Attendee
$229
How To Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities
29
/ Aug
Thursday-2019

How To Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities

  • Speaker: Javier Kuong
  • Product ID: 700095
  • Duration: 120 Min
This training will provide valuable knowledge on what companies need to do to establish an "effective" Compliance Office that leads to conceiving, developing and implementing successful GRC programs and provides top level coordinating leadership for governance, risk management and compliance issues across the enterprise.
* Per Attendee
$199
ISO 13485:2016 - What are the hot topics and changes?
3
/ Sep
Tuesday-2019

ISO 13485:2016 - What are the hot topics and changes?

  • Speaker: Frank Stein
  • Product ID: 705864
  • Duration: 90 Min
In this quality management system webinar attendees will learn the recent changes to ISO 13485:2016 standard in step by step process and how to implement these changes in their current quality management system to pass the quality management audit. Also attendees will gain knowledge on how to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems.
* Per Attendee
$199
Normality Tests and Normality Transformations: Explanations, Justifications, and Uses
5
/ Sep
Thursday-2019

Normality Tests and Normality Transformations: Explanations, Justifications, and Uses

  • Speaker: John N Zorich
  • Product ID: 706175
  • Duration: 90 Min
The calculations used in many statistical tests and methods require that the inputted data be “normally distributed”. This webinar explains what it means to be “normally distributed”, how to assess normality, how to test for normality, and how to transform non-normal data into normal data, and how to justify the transformations to internal and external quality system auditors.
* Per Attendee
$249
Failure Mode Effects Analysis
10
/ Sep
Tuesday-2019

Failure Mode Effects Analysis

  • Speaker: Michael Abitz
  • Product ID: 705333
  • Duration: 60 Min
This webinar will explain how to create Failure Mode Effects Analysis (FMEA) by combining Effective Information Collection (EIC), Process Reliability Modeling (PRM) and Failure Mode Effect Criticality Analysis (FMECA). It will also cover the methods for determining root causes of process problems and effective tools for repair of ineffective processes.
* Per Attendee
$229
Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU
11
/ Sep
Wednesday-2019

Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU

  • 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.
* Per Attendee
$249
Recorded/CD
CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

  • Speaker: Sunil Gupta
  • Product ID: 704316
  • Duration: 90 Min
This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide effective and practical solutions to address real-world issues.
CD/Recorded
$299
Recorded/CD
CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

  • Speaker: Sunil Gupta
  • Product ID: 704313
  • Duration: 90 Min
This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.
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
$299
Recorded/CD
Combination Drug/Device Products CGMPs - Final Rule

Combination Drug/Device Products CGMPs - Final Rule

  • Speaker: John E Lincoln
  • Product ID: 702810
  • Duration: 90 Min
This training on combination product regulations will evaluate the chief areas of concern or change in the new CGMP requirements for combination products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving combination products.
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
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