ComplianceOnline
Product Stability Testing Program - Designing and Sustaining New and Existing Programs
9
/ Dec
Monday-2019

Product Stability Testing Program - Designing and Sustaining New and Existing Programs

  • Speaker: Charity Ogunsanya
  • Product ID: 703000
  • Duration: 90 Min
This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.
* Per Attendee
$249
FDA's Ambitious Regulation of Social Media
10
/ Dec
Tuesday-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
Automating Assays for Clinical Diagnostics
11
/ Dec
Wednesday-2019

Automating Assays for Clinical Diagnostics

  • Speaker: Todd Graham
  • Product ID: 703268
  • Duration: 60 Min
This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.
* Per Attendee
$229
Recognizing and Responding to "Red Flags" in Clinical Operations
11
/ Dec
Wednesday-2019

Recognizing and Responding to "Red Flags" in Clinical Operations

  • Speaker: Peggy Berry
  • Product ID: 706094
  • Duration: 90 Min
Sponsors need to comply with various legal requirements for drug product development. These include communications with Federal and State Regulatory agencies. The post-marketing requirements include more functional areas of the company such as sales and marketing, medical affairs, and external spokespersons.
* Per Attendee
$249
Human Error Reduction Techniques for Floor Supervisors
13
/ Dec
Friday-2019

Human Error Reduction Techniques for Floor Supervisors

  • Speaker: Ginette M Collazo
  • Product ID: 706137
  • Duration: 90 Min
Attend this course to gain practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
* Per Attendee
$249
Handling OOS Test Results and Completing Robust Investigations
17
/ Dec
Tuesday-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
$249
Annual Current Good Manufacturing Practices (cGMP) Training
18
/ Dec
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
Good Documentation Guideline (Chapter <1029> USP)
22
/ Jan
Wednesday-2020

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
Sampling and Sample Preparation
2
/ Mar
Monday-2020

Sampling and Sample Preparation

  • Speaker: Mark Powell
  • Product ID: 706285
  • Duration: 60 Min
Sampling and sample preparation are both potential sources of variability and bias in analytical chemistry. The purpose of this webinar is to describe a scientifically-sound approach to sampling different types of analytical matrix (including liquids, gases and solids such as powder blends and tablets) and to describe the options available for sample extraction, clean-up and pre-concentration. The webinar would be useful for scientists developing analytical methods or writing sampling plans.
* Per Attendee
$229
Making Data Driven Decisions using Statistical Hypothesis Testing
19
/ Mar
Thursday-2020

Making Data Driven Decisions using Statistical Hypothesis Testing

  • Speaker: Steven Wachs
  • Product ID: 704211
  • Duration: 60 Min
This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes. Several types of hypothesis tests will be covered such as 1 and 2-sample means tests, tests of variances, and tests of proportions. Equivalence tests will also be discussed. The importance of selecting appropriate sample sizes will be stressed.
* Per Attendee
$229
How to Prepare a Standard Operating Procedure (SOP)?
27
/ Mar
Friday-2020

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 Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products
31
/ Mar
Tuesday-2020

FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

  • Speaker: Carolyn Troiano
  • Product ID: 705097
  • Duration: 90 Min
This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.
* Per Attendee
$249
Reviewing Drug Product Batch Records
1
/ Jun
Monday-2020

Reviewing Drug Product Batch Records

  • Speaker: Mark Powell
  • Product ID: 706287
  • Duration: 60 Min
Batch record review is an important step in the release of a medicinal product. This webinar sets out the regulatory requirements for batch records and sets out a systematic approach for review. Trending of batch data is also discussed.
* Per Attendee
$229
The Drug Development Process from Concept to Market
7
/ Sep
Monday-2020

The Drug Development Process from Concept to Market

  • Speaker: Mark Powell
  • Product ID: 706288
  • Duration: 60 Min
The goal of pharmaceutical development is to design a manufacturing process that can produce a drug product to a consistently high quality. This webinar sets out regulatory expectations for pharmaceutical development, taking account of the risk-based approach set out in ICH guidance documents (Q8, Q9, Q10 and draft Q12). It covers some examples of problems encountered during drug development.
* Per Attendee
$229
Recorded/CD
Overcoming Obstacles of The Canadian Drug Regulatory Landscape

Overcoming Obstacles of The Canadian Drug Regulatory Landscape

  • Speaker: Susanne Picard
  • Product ID: 706188
  • Duration: 60 Min
The Canadian Drug Approval Process is misunderstood by many and considered harsh by some. We will explore reasons why the Canadian market should not be overlooked and the benefits of including Canada in strategic drug development initiatives. We will share insights and practical examples that facilitate a positive, proactive and transparent interaction with Health Canada, and provide strategies for avoiding obstacles and managing them efficiently should they occur.
Recorded/CD
4-Hr Virtual Training: How to Respond to an FDA Investigation

4-Hr Virtual Training: How to Respond to an FDA Investigation

  • Speaker: Joy McElroy
  • Product ID: 704549
  • Duration: 4 hrs
This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.
CD/Recorded
$449
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
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

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.
CD/Recorded
$299
Recorded/CD
Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

  • Speaker: Vanessa Lopez
  • Product ID: 704758
  • Duration: 90 Min
This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.
CD/Recorded
$299
Recorded/CD
Best Practices for an Effective Cleaning Validation Program

Best Practices for an Effective Cleaning Validation Program

  • Speaker: Joy McElroy
  • Product ID: 704329
  • Duration: 60 Min
This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.
CD/Recorded
$299
Best Sellers
You Recently Viewed
    Loading