ComplianceOnline

Biotechnology Regulations and Guidance Training - Live Webinars, Recordings & CDs

Software Validation and its 11 Key Documents
17
/ Apr
Wednesday-2019

Software Validation and its 11 Key Documents

  • Speaker: John E Lincoln
  • Product ID: 703097
  • Duration: 90 Min
This webinar focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.
* Per Attendee
$249
Human Error Investigations, Root Cause Determination and CAPA Effectiveness
25
/ Apr
Thursday-2019

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.
* Per Attendee
$249
Good Documentation Guideline (Chapter <1029> USP)
26
/ Apr
Friday-2019

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
$229
Handling OOS Test Results and Completing Robust Investigations
2
/ May
Thursday-2019

Handling OOS Test Results and Completing Robust Investigations

  • Speaker: Danielle DeLucy
  • Product ID: 704351
  • Duration: 90 Min
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
* Per Attendee
$199
How to Prepare a Standard Operating Procedure (SOP)?
31
/ May
Friday-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
FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More
13
/ Jun
Thursday-2019

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

  • Speaker: Danielle DeLucy
  • Product ID: 704659
  • Duration: 60 Min
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
* Per Attendee
$229
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
Recorded/CD
New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

  • Speaker: Angela Bazigos
  • Product ID: 704529
  • Duration: 90 Min
This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.
CD/Recorded
$249
Recorded/CD
How to Conduct Annual Product Reviews to Achieve GMP Compliance

How to Conduct Annual Product Reviews to Achieve GMP Compliance

  • Speaker: Danielle DeLucy
  • Product ID: 704993
  • Duration: 60 Min
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.
CD/Recorded
$299
Recorded/CD
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer

  • Speaker: Gregory Martin
  • Product ID: 703644
  • Duration: 90 Min
This training on using the QbD approach to analytical method lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. The webinar presenter will use case studies to illustrate each stage in the process.
CD/Recorded
$299
Recorded/CD
Guideline to Aseptic Technique and Clean Room Behavior

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.
CD/Recorded
$299
Recorded/CD
Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

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.
CD/Recorded
$299
Recorded/CD
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

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

  • Speaker: Ginette M Collazo
  • Product ID: 704210
  • Duration: 60 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.
CD/Recorded
$299
Recorded/CD
Understanding and Implementing a Technology Transfer Process

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.
CD/Recorded
$299
Recorded/CD
The Most Serious FDA 483s - How to Avoid Them

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.
CD/Recorded
$299
Recorded/CD
Root Cause Analysis - The Heart of Corrective Action

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.
CD/Recorded
$299
Recorded/CD
FDA Regulations for Environmental Monitoring (EM) Program

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.
CD/Recorded
$299
Recorded/CD
Current Concepts and Challenges in Cloud Compliance

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.
CD/Recorded
$299
Recorded/CD
CDISC Mapping 1: Specifications and FDA Requirements

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).
CD/Recorded
$299
Recorded/CD
Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

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.
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