ComplianceOnline

Regulations & Guidances Compliance Training - Live Webinars, Recordings & CDs

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
20
/ Feb
Wednesday-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
Current Concepts and Challenges in Cloud Compliance
21
/ Feb
Thursday-2019

Current Concepts and Challenges in Cloud Compliance

  • Speaker: Angela Bazigos
  • Product ID: 703739
  • Duration: 90 Min
Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
* Per Attendee
$229
Pharmacokinetics/Biopharmaceutics for Chemists/Analysts
21
/ Feb
Thursday-2019

Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

  • Speaker: Saeed Qureshi
  • Product ID: 705271
  • Duration: 120 Min
This training program will focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic physiological concepts pertinent to drug actions, product developments and evaluations.
* Per Attendee
$249
HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
21
/ Feb
Thursday-2019

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

  • Speaker: Roger Cowan
  • Product ID: 703831
  • Duration: 60 Min
Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product. This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.
* Per Attendee
$229
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
26
/ Feb
Tuesday-2019

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

  • Speaker: Ginette M Collazo
  • Product ID: 704210
  • Duration: 90 Min
This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.
* Per Attendee
$229
CDISC Mapping 1: Specifications and FDA Requirements
27
/ Feb
Wednesday-2019

CDISC Mapping 1: Specifications and FDA Requirements

  • Speaker: Sunil Gupta
  • Product ID: 704152
  • Duration: 90 Min
This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).
* Per Attendee
$229
FDA Regulations for Environmental Monitoring (EM) Program
4
/ Mar
Monday-2019

FDA Regulations for Environmental Monitoring (EM) Program

  • Speaker: Joy McElroy
  • Product ID: 704377
  • Duration: 90 Min
This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.
* Per Attendee
$199
Root Cause Analysis - The Heart of Corrective Action
5
/ Mar
Tuesday-2019

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
The Most Serious FDA 483s - How to Avoid Them
12
/ Mar
Tuesday-2019

The Most Serious FDA 483s - How to Avoid Them

  • Speaker: John E Lincoln
  • Product ID: 702766
  • Duration: 90 Min
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.
* Per Attendee
$249
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers
12
/ Mar
Tuesday-2019

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

  • Speaker: Roger Cowan
  • Product ID: 703476
  • Duration: 60 Min
This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.
* Per Attendee
$199
Understanding and Implementing a Technology Transfer Process
13
/ Mar
Wednesday-2019

Understanding and Implementing a Technology Transfer Process

  • Speaker: Steven Laurenz
  • Product ID: 705031
  • Duration: 60 Min
This webinar will discuss the steps to guide the technology transfer for the successful implementation, ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.
* Per Attendee
$229
FDA Regulations for Marketing OTC Drugs in the U.S.
14
/ Mar
Thursday-2019

FDA Regulations for Marketing OTC Drugs in the U.S.

  • Speaker: Norma Skolnik
  • Product ID: 704145
  • Duration: 60 Min
This training program will illustrate why it’s essential to understand FDA regulations and OTC labeling requirements to market OTC drugs in the U.S.
* Per Attendee
$229
Technical Writing for Medical Products: SOPs, Investigations and Change Records
14
/ Mar
Thursday-2019

Technical Writing for Medical Products: SOPs, Investigations and Change Records

  • Speaker: Regina Fullin
  • Product ID: 704304
  • Duration: 60 Min
In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.
* Per Attendee
$229
Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
22
/ Mar
Friday-2019

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

  • Speaker: Joy McElroy
  • Product ID: 705929
  • Duration: 90 Min
In this cleaning validation webinar attendees will learn the Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.
* Per Attendee
$249
Guideline to Aseptic Technique and Clean Room Behavior
28
/ Mar
Thursday-2019

Guideline to Aseptic Technique and Clean Room Behavior

  • Speaker: Danielle DeLucy
  • Product ID: 704429
  • Duration: 60 Min
This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.
* Per Attendee
$229
Recorded/CD
Understanding and Implementing a Quality by Design (QbD) Program

Understanding and Implementing a Quality by Design (QbD) Program

  • Speaker: Steven Laurenz
  • Product ID: 705001
  • Duration: 60 Min
This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.
CD/Recorded
$299
Recorded/CD
Data Governance for Computer Systems Regulated by FDA

Data Governance for Computer Systems Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 704745
  • Duration: 60 Min
In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.
CD/Recorded
$249
Recorded/CD
Cell Based Assays: Development and Validation

Cell Based Assays: Development and Validation

  • Speaker: Michael Simonian
  • Product ID: 704528
  • Duration: 60 Min
This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.
Recorded/CD
How to Conduct Successful Supplier Audits

How to Conduct Successful Supplier Audits

  • Speaker: Danielle DeLucy
  • Product ID: 704499
  • Duration: 60 Min
This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations. When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier’s acceptability is to audit the operation.
CD/Recorded
$249
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
$249
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