ComplianceOnline
Hello. Sign In Your Account
Welcome back! Please log in below to continue.
Forgot Password?
New customer? Free Signup
Cart
Your Shopping Cart
Contains 0 items
Total: $0.00
View Shopping Cart
Toll Free:
+1-888-717-2436
Home › Online Training ›  Pharmaceutical Training

Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

Sub Categories: GXP Pharmaceutical | Drug Marketing Compliance | Quality and Safety | Audits & Inspections | Crisis Management | Supply Chain and Manufacturing | Cosmetics | Drug Development | Regulations & Guidances | Documentation and Data Management
Loading....
Analytical Method Validation Best Practices for Pharma Companies
13
/ Dec
Thursday-2018

Analytical Method Validation Best Practices for Pharma Companies

  • Speaker: Loren Gelber
  • Product ID: 705838
  • Duration: 90 Min
This analytical method validation webinar will help you understand the various parameters required for a successful method validation. It will highlight various requirements of USP and FDA for a successful method validation. This will be helpful for All pharmaceutical analytical chemists & supervisors responsible for validating new or modified analytical methods, and the personnel responsible for hosting FDA inspections, responding to 483s and Warning Letters or preparing NDAs or ANDAs.
* Per Attendee
$229
View Details
How to Conduct Successful Supplier Audits
13
/ Dec
Thursday-2018

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.
* Per Attendee
$199
View Details
Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training
19
/ Dec
Wednesday-2018

Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

  • Speaker: Gwen Wise Blackman
  • Product ID: 705019
  • Duration: 180 Min
This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.
* Per Attendee
$299
View Details
Current Concepts and Challenges in Cloud Compliance
7
/ Jan
Monday-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.
View Details
Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration
15
/ Jan
Tuesday-2019

Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

  • Speaker: Jose Mora
  • Product ID: 703396
  • Duration: 90 Min
This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to controlled document system for a life sciences manufacturing plant.
* Per Attendee
$199
View Details
Cell Based Assays: Development and Validation
16
/ Jan
Wednesday-2019

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.
* Per Attendee
$199
View Details
Technical Writing for Medical Products: SOPs, Investigations and Change Records
17
/ Jan
Thursday-2019

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

  • Speaker: Regina Fullin
  • Product ID: 704304
  • Duration: 120 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
View Details
Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971
17
/ Jan
Thursday-2019

Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971

  • Speaker: Tanvir Mahmud
  • Product ID: 702422
  • Duration: 90 Min
This 90-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.
* Per Attendee
$199
View Details
Pharmaceutical Water System: Design, Testing and Data Management
17
/ Jan
Thursday-2019

Pharmaceutical Water System: Design, Testing and Data Management

  • Speaker: Charity Ogunsanya
  • Product ID: 705863
  • Duration: 90 Min
In this pharmaceutical water system webinar attendees will learn how to design, validate and maintain the new and existing water systems used in drug product manufacturing process. Different types of routine tests, testing frequencies, actions in each tests and sampling procedures associated with pharmaceutical water systems will be discussed to avoid any water systems failures.
* Per Attendee
$199
View Details
Data Governance for Computer Systems Regulated by FDA
23
/ Jan
Wednesday-2019

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.
* Per Attendee
$199
View Details
Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory
31
/ Jan
Thursday-2019

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

  • Speaker: Gregory Martin
  • Product ID: 702534
  • Duration: 120 Min
This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.
* Per Attendee
$199
View Details
Hazard Analysis and Product Risk Management Under ISO 14971 and ICH Q9
13
/ Feb
Wednesday-2019

Hazard Analysis and Product Risk Management Under ISO 14971 and ICH Q9

  • Speaker: John E Lincoln
  • Product ID: 701693
  • Duration: 60 Min
In this product risk management webinar attendees will understand the key requirements of ISO 14971 (2007 and 2012) and ICH Q9. Also attendees will learn how to develop and implement product risk management planning through ISO 14971 & ICH Q9 to increase the product safety and reduced liability.
* Per Attendee
$199
View Details
Process Capability for Normal and Non-Normal
13
/ Feb
Wednesday-2019

Process Capability for Normal and Non-Normal

  • Speaker: Steven Wachs
  • Product ID: 705020
  • Duration: 90 Min
This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.
* Per Attendee
$199
View Details
Successful Water System Sanitization
13
/ Feb
Wednesday-2019

Successful Water System Sanitization

  • Speaker: T.C Soli
  • Product ID: 705825
  • Duration: 60 Min
This webinar will discuss common problems of sanitization process, the causes of sanitization failures and teach how to troubleshoot and take remedial actions with respect to material, construction methods, biofilm removal process and timing of sanitization.
* Per Attendee
$169
View Details
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
$199
View Details
Recorded/CD
GMPs for Medical Marijuana Production Operations

GMPs for Medical Marijuana Production Operations

  • Speaker: Charles H Paul
  • Product ID: 705872
  • Duration: 60 Min
In this webinar attendees will learn the good manufacturing practices required for any medical marijuana production operations related to international and US individual state cannabis regulations to determine how to best operate their cannabis operations.
View Details
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
View Details
Recorded/CD
Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

  • Speaker: John E Lincoln
  • Product ID: 704848
  • Duration: 90 Min
A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.
CD/Recorded
$249
View Details
Recorded/CD
Steam Sterilization Microbiology and Autoclave Performance Qualification

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.
CD/Recorded
$249
View Details
Recorded/CD
Validation and Use of Cloud Computing in FDA Regulated Environments

Validation and Use of Cloud Computing in FDA Regulated Environments

  • Speaker: Dr. Ludwig Huber
  • Product ID: 703423
  • Duration: 75 Min
This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.
CD/Recorded
$249
View Details
Best Sellers
You Recently Viewed
    Loading