ComplianceOnline
FDA's Ambitious Regulation of Social Media
24
/ Jun
Monday-2019

FDA's Ambitious Regulation of Social Media

  • Speaker: Casper Uldriks
  • Product ID: 703853
  • Duration: 60 Min
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
* Per Attendee
$229
Raw Materials in Pharma/Biotech Production
26
/ Jun
Wednesday-2019

Raw Materials in Pharma/Biotech Production

  • Speaker: Peggy Berry
  • Product ID: 706077
  • Duration: 90 Min
In the webinar, gain the skills for practical implementation of regulatory requirements for Pharma/Biotech raw material selection, receipt, testing, storage, and use in production.
* Per Attendee
$249
Annual Current Good Manufacturing Practices (cGMP) Training
26
/ Jun
Wednesday-2019

Annual Current Good Manufacturing Practices (cGMP) Training

  • Speaker: Kelly Thomas
  • Product ID: 705422
  • Duration: 60 Min
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
* Per Attendee
$199
Pharmaceutical Water System: Design, Testing and Data Management
27
/ Jun
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
$249
Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program
27
/ Jun
Thursday-2019

Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program

  • Speaker: Todd Graham
  • Product ID: 703066
  • Duration: 60 Min
This webinar will tell you what you need to know to design a compliant vendor program, implement it throughout the organization, manage the necessary documentation and effectively communicate with vendors your requirements, needs and issues.
* Per Attendee
$229
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
28
/ Jun
Friday-2019

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

  • Speaker: Charity Ogunsanya
  • Product ID: 703875
  • Duration: 90 Min
This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.
* Per Attendee
$249
Best Practices of Writing SOPs
1
/ Jul
Monday-2019

Best Practices of Writing SOPs

  • Speaker: Michael Esposito
  • Product ID: 705614
  • Duration: 90 Min
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood how the writing of a procedure can have a positive or negative impact on training. In this course you will learn the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.
* Per Attendee
$199
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. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.
* Per Attendee
$249
Onboarding in a GMP Environment: Best Practices for Foundational Employee Success
8
/ Jul
Monday-2019

Onboarding in a GMP Environment: Best Practices for Foundational Employee Success

  • Speaker: Michael Esposito
  • Product ID: 705475
  • Duration: 75 Min
This onboarding course is geared toward the pharmaceutical industry, particularly for anyone who is responsible for managing or delivering training in a GMP environment, and HR employees who interact frequently with the GMP training organization to coordinate onboarding. The aim of the course is to provide practical information, which has already been used on the job effectively, and suggest similar actions that learners can apply to their job situations quickly.
* Per Attendee
$199
Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products
9
/ Jul
Tuesday-2019

Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products

  • Speaker: J. Jeff Schwegman
  • Product ID: 702893
  • Duration: 90 Min
This training on lyophilization cycles will cover the process of transferring and or scaling-up a lyophilization process to a larger or different freeze-dryer. It will discuss a methodical approach to understand the thermal properties of a product and simplify the scale-up or transfer process resulting in a consistent product being produced in any freeze-dryer.
* Per Attendee
$249
Challenges of an Effective Change Control Program
10
/ Jul
Wednesday-2019

Challenges of an Effective Change Control Program

  • Speaker: Kenneth Christie
  • Product ID: 704638
  • Duration: 90 Min
This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.
* Per Attendee
$249
Implementing a GxP Quality Management System
10
/ Jul
Wednesday-2019

Implementing a GxP Quality Management System

  • Speaker: William D Fox
  • Product ID: 706079
  • Duration: 90 Min
This 90-minute GxP Quality Management System webinar introduces you to the planning and implementation of a QMS using a pharmaceutical QMS as a working model and focuses on fundamental concepts of quality, managing quality, systems, processes, managing change and assessment tools.
* Per Attendee
$249
How to Prepare a Standard Operating Procedure (SOP)?
11
/ Jul
Thursday-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
Comparability Protocols For Approved Drugs
12
/ Jul
Friday-2019

Comparability Protocols For Approved Drugs

  • Speaker: Peggy Berry
  • Product ID: 706102
  • Duration: 90 Min
This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission. The information obtained will enable completion of appropriate testing to make changes to the drug substance or drug product formulation, manufacturing facility, and container closure which can be designed to save time and money in the future.
* Per Attendee
$249
Pharmaceutical Data Integrity
12
/ Jul
Friday-2019

Pharmaceutical Data Integrity

  • Speaker: Mark Powell
  • Product ID: 706101
  • Duration: 60 Min
Data integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.
* Per Attendee
$229
Recorded/CD
Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

  • Speaker: Roger Cowan
  • Product ID: 703590
  • Duration: 60 Min
This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality.
CD/Recorded
$249
Recorded/CD
CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

  • Speaker: Sunil Gupta
  • Product ID: 704302
  • Duration: 90 Min
This training program will assist 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. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.
CD/Recorded
$299
Recorded/CD
FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

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.
CD/Recorded
$299
Recorded/CD
Strategies to Mitigate Preclinical Safety Risks in Drug Discovery

Strategies to Mitigate Preclinical Safety Risks in Drug Discovery

  • Speaker: Bryan Norman
  • Product ID: 706071
  • Duration: 90 Min
This webinar will discuss current best practices in understanding, assessing and mitigating many preclinical safety concerns in drug discovery. It will highlight many of the primary factors impacting drug safety, such as drug properties, target and tissue specificity, metabolic profile and reactive metabolite formation. It will also demonstrate many modern preclinical mitigation strategies and techniques to improve the safety of potential drug candidates.
Recorded/CD
The Importance of Packaging and Labeling in Pharmaceutical Product Development

The Importance of Packaging and Labeling in Pharmaceutical Product Development

  • Speaker: Michael Esposito
  • Product ID: 706063
  • Duration: 60 Min
Packaging and labeling is often underestimated in the planning phases of pharmaceutical product development. This leads to unnecessary increases in cycle time, costly errors, and delays in product availability, or product recalls due to noncompliance. This webinar will help you succeed in pharmaceutical product launch by exploring its importance right from the conception of a product, its realization and distribution.
CD/Recorded
$299
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