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
Surviving an FDA Sponsor Inspection - Training for Success
20
/ Aug
Tuesday-2019

Surviving an FDA Sponsor Inspection - Training for Success

  • Speaker: Stephen Schwartz
  • Product ID: 704516
  • Duration: 105 Min
This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.
* 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
Being the Center of Attention
26
/ Aug
Monday-2019

Being the Center of Attention

  • Speaker: Justin Muscolino
  • Product ID: 706148
  • Duration: 90 Min
Send your team to this training program to help them learn how to develop the necessary skills to conduct meetings and deliver presentations. This course will explore how to overcome interruptions and handle a difficult audience. By the end of this training, their capabilities will be enhanced to handle various situations when being the center of attention in any environment.
* Per Attendee
$249
USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure
27
/ Aug
Tuesday-2019

USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure

  • Speaker: Kelly Thomas
  • Product ID: 706164
  • Duration: 60 Min
Attend this webinar to learn how to be fully compliant with the USDA Final Rule on Bioengineered Food Disclosure, disclosure requirements in product labeling; disclosure options available to food manufacturers and distributors; symbols to be used and graphic requirements; and the timelines for compliance.
* Per Attendee
$229
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
What to Expect from FDA's Approach to Regulate Medical Software
29
/ Aug
Thursday-2019

What to Expect from FDA's Approach to Regulate Medical Software

  • Speaker: Dennis Weissman
  • Product ID: 706085
  • Duration: 60 Min
The FDA’s emerging approach to medical software product regulation has important ramifications for patients, healthcare providers and insurers as well as product developers. So, it is critically important for companies throughout the life sciences and healthcare industries that utilize software in its products to understand the important challenges and opportunities presented by this major policy shift. This webinar will provide understanding.
* Per Attendee
$229
C-TPAT Compliance for FDA-Regulated Industries
30
/ Aug
Friday-2019

C-TPAT Compliance for FDA-Regulated Industries

  • Speaker: Carolyn Troiano
  • Product ID: 706158
  • Duration: 90 Min
Attend this webinar to get an overview of the Customs and Trade Partnership Against Terrorism including “Tiered” strategy, guidelines, highlights, and compliance. We will also cover the major areas needed to build a successful framework that will support your compliance program including policies, SOPs, documentation, and training.
* Per Attendee
$249
The Mindset of an FDA Employee
6
/ Sep
Friday-2019

The Mindset of an FDA Employee

  • Speaker: Larry Stevens
  • Product ID: 706174
  • Duration: 60 Min
If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. It is important to interact with the FDA employee in the most productive manner. But there is a variable you must deal with that will determine how productive your interaction is. The variable is the FDA employee. That is the purpose of this webinar.
* Per Attendee
$229
Writing Effective IQ, OQ,PQ Protocols for Equipment Qualification
10
/ Sep
Tuesday-2019

Writing Effective IQ, OQ,PQ Protocols for Equipment Qualification

  • Speaker: Joy McElroy
  • Product ID: 705763
  • Duration: 90 Min
This equipment qualification webinar will discuss the requirements for IQ, OQ, and PQ protocols. It will train about the various components of each protocol, Proper language for documenting qualification testing including how to Collect data, conduct tests, and obtaining all necessary documents.
* Per Attendee
$249
Avoid Documentation 'Time Bombs'
11
/ Sep
Wednesday-2019

Avoid Documentation 'Time Bombs'

  • Speaker: John E Lincoln
  • Product ID: 701407
  • Duration: 60 Min
This documentation training will explain regulatory ramification of communication done through Lab books, SOPs, DHF, technical files etc and how to reduce it.
* Per Attendee
$229
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
Steam Sterilization Microbiology and Autoclave Performance Qualification
16
/ Sep
Monday-2019

Steam Sterilization Microbiology and Autoclave Performance Qualification

  • Speaker: Danielle DeLucy
  • Product ID: 705027
  • Duration: 60 Min
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
* Per Attendee
$229
Biocompatibility Testing; what you need to know
19
/ Sep
Thursday-2019

Biocompatibility Testing; what you need to know

  • Speaker: Mike Colvin
  • Product ID: 705585
  • Duration: 90 Min
This Webinar is geared toward those who require a working knowledge of biocompatibility.
* Per Attendee
$199
How to Develop, Implement and Manage an Effective Change Control Program
19
/ Sep
Thursday-2019

How to Develop, Implement and Manage an Effective Change Control Program

  • Speaker: Kelly Thomas
  • Product ID: 705909
  • Duration: 90 Min
This Change Control training program will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough Change Control program; as well as, discuss the elements regarding successful management an effective Change Control system.
* 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
Process Reliability Modeling: Measure the Cause Not the Effect of Process Variations

Process Reliability Modeling: Measure the Cause Not the Effect of Process Variations

  • Speaker: Michael Abitz
  • Product ID: 705334
  • Duration: 60 Min
This webinar will discuss in detail Process Reliability Modeling (PRM) method including its history, the process, validation, and results of effective management, sigma score and customer satisfaction. Attendees will learn how to convert qualitative information into quantitative data to determine process and system reliability.
CD/Recorded
$229
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
Developing a Strategic Approach to FDA Compliance for Computer Systems

Developing a Strategic Approach to FDA Compliance for Computer Systems

  • Speaker: Carolyn Troiano
  • Product ID: 706124
  • Duration: 90 Min
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. We will focus on how to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do and ensure that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project, along with the importance of the sequence of steps and deliverables.
CD/Recorded
$299
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