- 14
- April
- 2021
- Wednesday
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 14
- April
- 2021
- Wednesday
Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles on Lean Documents and Lean Configuration
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
Jose Mora |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 14
- April
- 2021
- Wednesday
Auditing Laboratories Conducting Assays Supporting Biologics
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.
Gwendolyn Wise-Blackman |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 14
- April
- 2021
- Wednesday
Understanding International Logistics- The Basics of Air and Ocean Shipping
Air freight, or air cargo allows the transport of goods quickly by air. Shipping cargo by air has always been a high cost-to-weight form of shipment, countered by the fact that it is the fastest way to transport goods internationally.
Martin K. Behr, III |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 14
- April
- 2021
- Wednesday
Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends
CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.
David R Dills |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 14
- April
- 2021
- Wednesday
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Dr. Ludwig Huber |
Duration: 75 Minutes |
Price: $150.00
| View Details
- 15
- April
- 2021
- Thursday
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
John C. Fetzer |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 15
- April
- 2021
- Thursday
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Robert J. Russell |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 15
- April
- 2021
- Thursday
Bulletproof CAPA Process: How to do it Right?
Mr. Yuval Shapiro shall present the requirements for Corrective and Preventive actions as required by medical devices standards (ISO13485, etc.), and the common practice.
Yuval Shapiro |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 15
- April
- 2021
- Thursday
6-Hour Virtual Seminar on Statistics for Quality Control
This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.
Elaine Eisenbeisz |
Duration: 6 Hours |
Price: $545.00
| View Details
- 16
- April
- 2021
- Friday
Surviving OSHA Audit in Six Easy Steps
Recently, OSHA issued over 40,000 citations for safety violations in the workplace. In one example, a HVAC company was fined over $1.2 million for recordkeeping violations.
Deidre Tate |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 16
- April
- 2021
- Friday
2-Hour Virtual Seminar on Power Analysis for Sample Size Calculations
In this webinar attendees will learn the statistical power analysis and techniques for determining sample size (a priori techniques) calculation.
Elaine Eisenbeisz |
Duration: 2 Hours |
Price: $190.00
| View Details
- 16
- April
- 2021
- Friday
FDA Issues Final Rule on Symbols in Labeling
The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.
David R Dills |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 16
- April
- 2021
- Friday
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.
Dennis Taylor |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 16
- April
- 2021
- Friday
2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.
Dr. Ludwig Huber |
Duration: 2 Hours |
Price: $190.00
| View Details
- 19
- April
- 2021
- Monday
How to write SOP's that Avoid Human Error
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.
Ginette Collazo |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 19
- April
- 2021
- Monday
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Robert J. Russell |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 19
- April
- 2021
- Monday
Time-Saving Excel Tips, Tricks and 100 Shortcuts
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Dennis Taylor |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 20
- April
- 2021
- Tuesday
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 20
- April
- 2021
- Tuesday
Equipment Validation, Tracking, Calibration and Preventive Maintenance
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment.
Jeff Kasoff |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 20
- April
- 2021
- Tuesday
Water System Mythology: Common False Beliefs for Microbial Control and Monitoring
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Teri C. Soli |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 20
- April
- 2021
- Tuesday
Handling OOS Test Results and Completing Robust Investigations
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.
Danielle DeLucy |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 20
- April
- 2021
- Tuesday
FDA Audit Best Practices - Do's and Don'ts
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Charles H. Paul |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 20
- April
- 2021
- Tuesday
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
Angela Bazigos |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 20
- April
- 2021
- Tuesday
6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Carolyn Troiano |
Duration: 6 Hours |
Price: $545.00
| View Details
- 20
- April
- 2021
- Tuesday
Using Statistics to Determine Sample Size
We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.
Steven Wachs |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 20
- April
- 2021
- Tuesday
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.
David R Dills |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 21
- April
- 2021
- Wednesday
Analytical Method Validation
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.
Jerry Lanese |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 21
- April
- 2021
- Wednesday
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records
Jose Mora |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 21
- April
- 2021
- Wednesday
Cost of Quality from Theory to Implementation
How could one assess the effectiveness of a Quality Management System? The best way to do that, is by using the ultimate transfer unit: MONEY!
Yuval Shapiro |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 21
- April
- 2021
- Wednesday
4-Hour Virtual Seminar on Credit Risk Management- Principles and Practices, Tools and Techniques
Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives.
Dev Strischek |
Duration: 4 Hours |
Price: $445.00
| View Details
- 21
- April
- 2021
- Wednesday
2-Hour Virtual Seminar on The 6 Most Common Problems in FDA Software Validation and Verification
This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls.
David Nettleton |
Duration: 2 Hours |
Price: $190.00
| View Details
- 21
- April
- 2021
- Wednesday
Postmarketing Vigilance Reporting For Medical Device Manufacturers
Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 6) came into force on January 1, 2008.
David R Dills |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 22
- April
- 2021
- Thursday
Preparing for OSHA Voluntary Protection Program (VPP): Brick by Brick
The OSHA Voluntary Protection Program (VPP) is the highest award in Health and Safety Excellence that OSHA presents to an organization.
Deidre Tate |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 22
- April
- 2021
- Thursday
Foreign Trade Zones- Understanding and Making Good Use of Them
U.S. foreign-trade zones (FTZs) are geographic areas declared to be outside the normal customs territory of the United States.
Martin K. Behr, III |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 22
- April
- 2021
- Thursday
Responsibility for Off-label Claims in Social Media
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Casper Uldriks |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 22
- April
- 2021
- Thursday
6-Hour Virtual Seminar on Adaptive Design for Clinical Trials
Clinical trials are expensive, time-consuming, and labor-intensive. And in the traditional sense, study designs are inflexible.
Elaine Eisenbeisz |
Duration: 6 Hours |
Price: $545.00
| View Details
- 23
- April
- 2021
- Friday
Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Danielle DeLucy |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 23
- April
- 2021
- Friday
Key Elements in Managing and Maintaining your Credit Administration and Credit Policy
This session by Dev Strischek is intended to provide guidance on how to develop and maintain a Credit Administration (CA) function that will provide guidance to anyone involved in the credit function of the bank.
Dev Strischek |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 23
- April
- 2021
- Friday
Conducting Successful Product Complaint Investigations
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
David R Dills |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 23
- April
- 2021
- Friday
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Dr. Ludwig Huber |
Duration: 75 Minutes |
Price: $150.00
| View Details
- 26
- April
- 2021
- Monday
3-Hour Virtual Seminar on Human Error Reduction in GMP Related Environments
Human error is known to be the primary cause of quality and production losses in many industries.
Ginette Collazo |
Duration: 3 Hours |
Price: $290.00
| View Details
- 26
- April
- 2021
- Monday
3-Hour Virtual Seminar on Design Controls for Medical Devices
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Susanne Manz |
Duration: 3 Hours |
Price: $290.00
| View Details
- 26
- April
- 2021
- Monday
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Robert J. Russell |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 26
- April
- 2021
- Monday
6-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. Now expanded to a six-hour format. As U.S. companies go global, they must meet different product design documentation.
John E Lincoln |
Duration: 6 Hours |
Price: $545.00
| View Details
- 26
- April
- 2021
- Monday
Power Analysis for Sample Size Calculations
In this webinar attendees will learn the statistical power analysis and techniques for determining sample size (a priori techniques) calculation.
Elaine Eisenbeisz |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 26
- April
- 2021
- Monday
Useful Statistical Methods for Defining Product and Process Specifications
Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.
Steven Wachs |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 26
- April
- 2021
- Monday
2-Hour Virtual Seminar on Mastering Excel Pivot Tables
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Dennis Taylor |
Duration: 2 Hours |
Price: $190.00
| View Details
- 27
- April
- 2021
- Tuesday
Data Integrity and Privacy for FDA Regulated Industries
Effective and compliant data management is critical to organizations in the regulated industries. Data integrity is defined as the extent to which all data is complete, consistent, accurate, trustworthy, and reliable throughout the data lifecycle, from its creation to archiving and its eventual destruction.
Eleonora Babayants |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 27
- April
- 2021
- Tuesday
Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.
Jeff Kasoff |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 27
- April
- 2021
- Tuesday
Dietary Supplements CGMPS - 21 CFR 111 Compliance
21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.
John E Lincoln |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 27
- April
- 2021
- Tuesday
Managing Corporate Culture During COVID-19
Your organization needs to understand how to maintain team cohesiveness with a remote workforce that is working from home.
Robert Greene and Marques Ogden |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 27
- April
- 2021
- Tuesday
Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.
Teri C. Soli |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 27
- April
- 2021
- Tuesday
6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Robert J. Russell |
Duration: 6 Hours |
Price: $545.00
| View Details
- 27
- April
- 2021
- Tuesday
3-Hour Virtual Seminar on Project Management for Non-Project Managers
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Charles H. Paul |
Duration: 3 Hours |
Price: $290.00
| View Details
- 27
- April
- 2021
- Tuesday
3-Hour Virtual Seminar on Bootcamp on How the FDA are Trained for Medical Device Inspections
This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms. It will present the specific guidance FDA inspectors receive for each of the regulations.
Angela Bazigos |
Duration: 3 Hours |
Price: $290.00
| View Details
- 28
- April
- 2021
- Wednesday
The Human Error Tool Box: A Practical Approach to Human Error
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Ginette Collazo |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 28
- April
- 2021
- Wednesday
Laboratory Investigation of Out-of-Specification Results
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.
Jerry Lanese |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 28
- April
- 2021
- Wednesday
Analytical Method Validation Under Good Laboratory Practices - GLPs
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
John C. Fetzer |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 28
- April
- 2021
- Wednesday
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect.
Jose Mora |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 28
- April
- 2021
- Wednesday
6-Hour Virtual Seminar on Project Management for Non-Project Managers
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Charles H. Paul |
Duration: 6 Hours |
Price: $545.00
| View Details
- 28
- April
- 2021
- Wednesday
How to Prepare for and Host an FDA Inspection and respond to 483's
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 28
- April
- 2021
- Wednesday
Implementing Process Controls for Cell-Based Assays
Bioassays are used to demonstrate that a biologic product performs per the stated function and potency.
Gwendolyn Wise-Blackman |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 28
- April
- 2021
- Wednesday
The 6 Most Common Problems in FDA Software Validation and Verification
This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls.
David Nettleton |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 28
- April
- 2021
- Wednesday
3-Hour Virtual Seminar on Complaint Handling and Management: From Receipt to Trending
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
David R Dills |
Duration: 3 Hours |
Price: $290.00
| View Details
- 28
- April
- 2021
- Thursday
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations.
Dr. Ludwig Huber |
Duration: 75 Minutes |
Price: $150.00
| View Details
- 29 & 30
- April
- 2021
- Thursday
2-Day Virtual Seminar on Best Practices for Import & Export Control & Customs Compliance During & After COVID 19
FDA’s import and export programs are complex, detailed and undergo changes without notice to the public.
Casper Uldriks |
Duration: 2 Days |
Price: $995.00
| View Details
- 29
- April
- 2021
- Thursday
Preparing for an FDA Inspection - What you Need to Know
Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively.
Susanne Manz |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 29
- April
- 2021
- Thursday
6-Hour Virtual Seminar on Bootcamp on Excel
In this webinar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.
Tom Fragale |
Duration: 6 Hours |
Price: $545.00
| View Details
- 29
- April
- 2021
- Thursday
ISO13485: 2016 - Quality Management Systems for Medical Devices
This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.
Yuval Shapiro |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 29
- April
- 2021
- Thursday
6-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
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.
Michael Esposito |
Duration: 6 Hours |
Price: $545.00
| View Details
- 30
- April
- 2021
- Friday
GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems
Documentation is a critical tool for ensuring GxP/GMP compliance.
Eleonora Babayants |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 30
- April
- 2021
- Friday
Complaint Handling in Compliance with FDA and ISO Regulations
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.
Jeff Kasoff |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 30
- April
- 2021
- Friday
Good Manufacturing Practices (GMP) - An Introduction
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Michael Esposito |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 30
- April
- 2021
- Friday
Essentials of Validation - IQ, OQ, PQ
Validation is an important element of the Quality System Regulations and ISO13485.
Susanne Manz |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 30
- April
- 2021
- Friday
3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations
This webinar will review the regulatory requirements for investigating an OOS Investigation.
Danielle DeLucy |
Duration: 3 Hours |
Price: $290.00
| View Details
- 30
- April
- 2021
- Friday
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Carolyn Troiano |
Duration: 6 Hours |
Price: $545.00
| View Details
- 30
- April
- 2021
- Friday
Tips and Techniques for Handling Missing Data (Statistical Techniques)
If you work with data, you should attend this webinar. Real life data is not pretty. It is messy and often incomplete.
Elaine Eisenbeisz |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 30
- April
- 2021
- Friday
The Credit Manager's Tool Box - Tools And Techniques For Making Sound Credit Decisions
This webinar will provide guidance on how gather information, evaluate it, and make sound credit decisions on prospective clients and existing borrowers You will also learn the differences between unaudited and audited financials and how to use and interpret financial ratios in your analysis.
Dev Strischek |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 30
- April
- 2021
- Friday
Project Management for Non-Project Managers
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Charles H. Paul |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 30
- April
- 2021
- Friday
Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products
What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?
David R Dills |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 30
- April
- 2021
- Friday
3-Hour Virtual Seminar on Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA-EMA, USP and ICH
The 3-hour virtual seminar will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement even most critical requirements.
Dr. Ludwig Huber |
Duration: 3 Hours |
Price: $290.00
| View Details
- 4
- May
- 2021
- Tuesday
Combating Racism in the Workplace
You need to eradicate racism in the workplace and promote unity. Learn how to build an inclusive and equitable organization, ensure fairness for all employees, candidates, customers, and other stakeholders.
Robert Greene and Marques Ogden |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 5
- May
- 2021
- Wednesday
Verification vs Validation-Product, Process or Equipment and QMS Software
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.
John E Lincoln |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 5
- May
- 2021
- Wednesday
OSHA's Final Rule: Worker Exposure to Respirable Crystalline Silica
Exposure to silica has been linked to lung cancer, silicosis, chronic obstructive pulmonary disease, and kidney disease in workers.
Deidre Tate |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 5
- May
- 2021
- Wednesday
The Income Statement - What a Banker Can Learn About a Borrower from Its Profit and Loss Statement
This topic will explore all aspects of an income statement and Loss Statement and how the information that a profit and loss statement contains about a borrower's operating performance can assist in making credit decisions.
Dev Strischek |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 5
- May
- 2021
- Wednesday
3-Hour Virtual Seminar on Bioanalytical Method Validation
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Gwendolyn Wise-Blackman |
Duration: 3 Hours |
Price: $290.00
| View Details
- 5
- May
- 2021
- Wednesday
Controlling Human Error in the Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries.
Ginette Collazo |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 10
- May
- 2021
- Monday
Root Cause Analysis - Starting at the Beginning
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
John E Lincoln |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 10
- May
- 2021
- Monday
Secrets to Writing Effective SOPs for Medical Device QMS
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Susanne Manz |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 10
- May
- 2021
- Monday
Implementing an Effective CAPA System
CAPA, no matter how you look at it, is the heart of the quality management system. CAPA can be viewed as and is the merging of change control, continuous improvement, and complaint management.
Charles H. Paul |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 11
- May
- 2021
- Tuesday
Validation of HPLC/UPLC Methodologies
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
John C. Fetzer |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 11
- May
- 2021
- Tuesday
6-Hour Virtual Seminar on Validation and 21 CFR Part 11 Compliance of Computer Systems
This course is appropriate for beginner and experienced person alike.
Angela Bazigos |
Duration: 6 Hours |
Price: $545.00
| View Details
- 11
- May
- 2021
- Tuesday
Supervising a Human Error Free Environment: You can do a Lot More than you Think
Human error is known to be the major cause of quality and production losses in many industries.
Ginette Collazo |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 11
- May
- 2021
- Tuesday
Cash Flow Analysis Of Borrower's Repayment Ability
There is an old saying in credit analysis, "Borrowers pay back loans from cash flow, not profits." But it is not just cash flow; it is cash flow from operations that is the most desirable source of repayment because it is generated by a borrower managing its working capital assets and earning a sustainable profit.
Dev Strischek |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 12
- May
- 2021
- Wednesday
6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Charles H. Paul |
Duration: 6 Hours |
Price: $545.00
| View Details
- 12
- May
- 2021
- Wednesday
6-Hour Virtual Seminar on Good Laboratory Practices (GLPs) Comparing and Contrasting GMP
The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
Joy McElroy |
Duration: 6 Hours |
Price: $545.00
| View Details
- 12
- May
- 2021
- Wednesday
6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Robert J. Russell |
Duration: 6 Hours |
Price: $545.00
| View Details
- 13
- May
- 2021
- Thursday
Identifying Social Injustice and Racial Inequality in the Workplace
Outside stress on employees can impact work performance.
Robert Greene and Marques Ogden |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 17
- May
- 2021
- Monday
6-Hour Virtual Seminar on Statistical Process Control & Process Capability
Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to "listen" to their processes so that potentially harmful changes will be quickly detected and rectified.
Steven Wachs |
Duration: 6 Hours |
Price: $545.00
| View Details
- 18
- May
- 2021
- Tuesday
6-Hour Virtual Seminar on Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Danielle DeLucy |
Duration: 6 Hours |
Price: $545.00
| View Details
- 18
- May
- 2021
- Tuesday
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
Roger Cowan |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 18
- May
- 2021
- Tuesday
6-Hour Virtual Seminar on Auditing Analytical Laboratories for FDA Compliance
There are two phases to this topic. The first is auditing itself. Good audits are well structured.
Steven S. Kuwahara |
Duration: 6 Hours |
Price: $545.00
| View Details
- 19
- May
- 2021
- Wednesday
6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Robert J. Russell |
Duration: 6 Hours |
Price: $545.00
| View Details
- 20
- May
- 2021
- Thursday
3-Hour Virtual Seminar on CAPA for Medical Devices
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.
Susanne Manz |
Duration: 3 Hours |
Price: $290.00
| View Details
- 20
- May
- 2021
- Thursday
6-Hour Virtual Seminar on Combination Products
This seminar provides Professionals working in this area with:
Salma Michor |
Duration: 6 Hours |
Price: $545.00
| View Details
- 21
- May
- 2021
- Friday
6-Hour Virtual Seminar on Biostatistics for the Non-Statistician
Statistics is a useful decision making tool in the clinical research arena.
Elaine Eisenbeisz |
Duration: 6 Hours |
Price: $545.00
| View Details
- 24
- May
- 2021
- Monday
6-Hour Virtual Seminar on Phase I GMPs
Early clinical trials are conducted to establish initial safety of a drug.The studies are generally in small number of healthy subjects and use lower doses of the drug product.
Peggy Berry |
Duration: 6 Hours |
Price: $545.00
| View Details
- 24
- May
- 2021
- Monday
6-Hour Virtual Seminar on Statistics for the Non-Statistician
The world is swimming in data yet raw data is mostly useless without methods to turn this data into useful and actionable information.
Steven Wachs |
Duration: 6 Hours |
Price: $545.00
| View Details
- 25
- May
- 2021
- Tuesday
FDA Best Audit Behavior Practices - Do's and Don'ts
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Charles H. Paul |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 26
- May
- 2021
- Wednesday
6-Hour Virtual Seminar on Controlling Human Error in the Manufacturing Floor
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Ginette Collazo |
Duration: 6 Hours |
Price: $545.00
| View Details
- 26
- May
- 2021
- Wednesday
6-Hour Virtual Seminar on The New EU Medical Device Regulation
In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices.
Salma Michor |
Duration: 6 Hours |
Price: $545.00
| View Details
- 27
- May
- 2021
- Thursday
Account Based Marketing & Nurturing
Once a customer has been acquired, an organization needs to maximize the lifetime value of the relationship. This course will explore the following topics:
Robert Greene |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 28
- May
- 2021
- Friday
6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Devices)
This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance.
Joy McElroy |
Duration: 6 Hours |
Price: $545.00
| View Details
- 28
- May
- 2021
- Friday
6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada
The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.
Peggy Berry |
Duration: 6 Hours |
Price: $545.00
| View Details
- 1
- June
- 2021
- Tuesday
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
John E Lincoln |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 9
- June
- 2021
- Wednesday
Project Management for FDA-Regulated Companies
This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
John E Lincoln |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 22
- June
- 2021
- Tuesday
Device Changes, FDA Changes, and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
John E Lincoln |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 29
- June
- 2021
- Tuesday
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
John E Lincoln |
Duration: 3 Hours |
Price: $290.00
| View Details
- 7
- July
- 2021
- Wednesday
The Most Common Problems in FDA Software Validation & Verification
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
John E Lincoln |
Duration: 90 Minutes |
Price: $150.00
| View Details
Search Webinars
Topic: Not Specified
Category: All
Speaker: All
Month: Any