- 13
- January
- 2021
- Wednesday
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
- 13
- January
- 2021
- Wednesday
Design Control for Medical Devices
Since 1984 the FDA has identified the lack of proper design controls as one of the major reasons for device recalls.
John Chapman |
Duration:60 Minutes |
Price: $150.00
| View Details
- 18
- January
- 2021
- Monday
Personal Protective Equipment Requirements
Personal protective equipment, commonly referred to as "PPE", is equipment worn to minimize exposure to hazards that cause serious workplace injuries and illnesses.
Robert A. (Bob) LaRosa |
Duration:60 Minutes |
Price: $150.00
| View Details
- 18
- January
- 2021
- Monday
Master Excel: Spreadsheet Internal Controls
Excel expert David Ringstrom, CPA, shows you how to implement internal control features within your Excel spreadsheets in this enlightening presentation. David uses a simple invoice form as a teaching aid to present various ways to control users' actions within Excel spreadsheets and to protect worksheets and workbooks from unauthorized changes. David demonstrates every technique at least twice first, on a PowerPoint slide with numbered steps, and second, in Excel 2016. He'll draw to your attention any differences in Excel 2013, 2010, or 2007 during the presentation as well as in his detailed handouts. David also provides an Excel workbook that includes most of the examples he uses during the webcast.
David Ringstrom |
Duration:60 Minutes |
Price: $150.00
| View Details
- 19
- January
- 2021
- Tuesday
3-Hour Virtual Seminar on Harmonized Tariff Schedule Classification
In this webinar attendees will understand the rules that are required to classify products in the Harmonized Tariff Schedule.
Martin K. Behr, III |
Duration:3 Hours |
Price: $290.00
| View Details
- 19
- January
- 2021
- Tuesday
Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance
Human Factors/ Usability is the analysis of how people interact with medical devices.
Edwin Waldbusser |
Duration:60 Minutes |
Price: $150.00
| View Details
- 19
- January
- 2021
- Tuesday
Medical Device Cybersecurity and FDA Compliance
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Carolyn Troiano |
Duration:90 Minutes |
Price: $150.00
| View Details
- 19
- January
- 2021
- Tuesday
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
- 20
- January
- 2021
- Wednesday
Prepare Your Company to Meet the Final FSMA Subpart G Rule Requirements for the Receiver Liability for Supplier Preventive Controls
The FDA recommended course includes actual data, costs and examples from transportation tracked and measured operations, important definitions and reviews of federal and international requirements, established standards for management, HARPC, sanitation, temperature monitoring and traceability and training, types of adulterants, preventive practices, vehicle qualification, pre-shipment inspection, contamination flows, unseen bacteria, container temperature losses, obvious violations, the most advanced temperature monitoring, pallet types, carrier responsibilities, sanitation testing, and includes specific recommendations for carriers as well as shippers and receivers who receive carrier services.
John Ryan |
Duration:90 Minutes |
Price: $150.00
| View Details
- 20
- January
- 2021
- Wednesday
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
- 20
- January
- 2021
- Wednesday
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
- January
- 2021
- Wednesday
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
- 21
- January
- 2021
- Thursday
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
David Nettleton |
Duration:75 Minutes |
Price: $150.00
| View Details
- 21
- January
- 2021
- Thursday
How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
Jeff Kasoff |
Duration:60 Minutes |
Price: $150.00
| View Details
- 22
- January
- 2021
- Friday
Sample Size Determination for Design Validation Activities
Design Validation should ensure that product performance, quality, and reliability requirements are met.
Steven Wachs |
Duration:90 Minutes |
Price: $150.00
| View Details
- 25
- January
- 2021
- Monday
Hazardous Material Release Reporting Requirements
Hazardous materials pose a danger to the environment. Federal regulations require immediate reporting to specific agencies (federal and local) in the event of a release to the environment.
Robert A. (Bob) LaRosa |
Duration:60 Minutes |
Price: $150.00
| View Details
- 26
- January
- 2021
- Tuesday
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
- 26
- January
- 2021
- Tuesday
The Income Statement - What a Banker Can Learn About a Borrower from Its Profit and Loss Statement
This program is designed to show bankers, lenders and credit professionals:
Dev Strischek |
Duration:60 Minutes |
Price: $150.00
| View Details
- 26
- January
- 2021
- Tuesday
INCOTERMS 2020 Made Easy - Decoding your Shipment
The term, Incoterms®, is an abbreviation for International Commercial Terms.
Martin K. Behr, III |
Duration:90 Minutes |
Price: $150.00
| View Details
- 27
- January
- 2021
- Wednesday
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Robert J. Russell |
Duration:90 Minutes |
Price: $150.00
| View Details
- 27
- January
- 2021
- Wednesday
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
- 27
- January
- 2021
- Wednesday
Are You Ready for FDA FSMA Preventive Controls Audit?
This course will examine new FDA authority, introduces examples of Preventative Controls, leading into minimal recommended preparation steps for handling the new FDA FSMA requirements, including managing Form #483, or the FDA Warning for non-compliances.
Gina Reo |
Duration:60 Minutes |
Price: $150.00
| View Details
- 27
- January
- 2021
- Wednesday
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. This training program will guide attendees with best practices in implementing the OSHA VPP program.
Deidre Tate |
Duration:90 Minutes |
Price: $150.00
| View Details
- 28
- January
- 2021
- Thursday
1099 and W-9 Update - Complying with IRS Information Reporting
For years the IRS has struggled with the independent contractor and tax collection.
Miles Hutchinson |
Duration:90 Minutes |
Price: $150.00
| View Details
- 29
- January
- 2021
- Friday
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
- 29
- January
- 2021
- Friday
Sterile Filtration of Pharmaceutical Products -What you need to know to meet Validation and Regulatory Requirements
It is important that the sterile filtration process is fully understood and properly validated for your particular application.
Roger Cowan |
Duration:60 Minutes |
Price: $150.00
| View Details
- 29
- January
- 2021
- Friday
Data Integrity and Governance for Computer Systems Regulated by FDA
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry.
Carolyn Troiano |
Duration:90 Minutes |
Price: $150.00
| View Details
- 2
- February
- 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
- 3
- February
- 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
- 3
- February
- 2021
- Wednesday
Medical Device Hazard analysis following ISO 14971
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.
Edwin Waldbusser |
Duration:60 Minutes |
Price: $150.00
| View Details
- 4
- February
- 2021
- Thursday
What to Expect with the new FSMA Intentional Adulteration Regulation
IA establishes requirements to prevent or significantly minimize acts intended to cause wide-scale public health harm. The session will explain coverage, summarize requirements for facilities that manufacture, process, pack or hold human food.
Gina Reo |
Duration:60 Minutes |
Price: $150.00
| View Details
- 4
- February
- 2021
- Thursday
Classifying Your Products for International Trade: Plain Talk and Understanding
Importers must know how to classify imported products using the Harmonized Tariff Schedule of the United States (HTSUS).
Martin K. Behr, III |
Duration:90 Minutes |
Price: $150.00
| View Details
- 5
- February
- 2021
- Friday
Expedite Excel with Hidden Shortcuts
Excel expert David Ringstrom, CPA is fond of stating "Either you work Excel, or it works you!" In this fast-paced presentation David will share over two dozen ways that you can reclaim part of your day from Excel. You'll uncover mouse techniques, keyboard shortcuts, hidden menus, and even ways to create your own custom keyboard shortcuts in Excel.
David Ringstrom |
Duration:60 Minutes |
Price: $150.00
| View Details
- 8
- February
- 2021
- Monday
FDA Case Scenarios – Best Practices for Managing Inspection Situations
Companies can prepare and train their staffs effectively for prior inspection management, but once the audit begins, certain difficult situations, requests or issues may arise that may prove hard to manage properly.
Danielle DeLucy |
Duration:60 Minutes |
Price: $150.00
| View Details
- 8
- February
- 2021
- Monday
3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11
Part 11 / Annex 11 Computer Systems Validation (CSV) is to be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance.
Angela Bazigos |
Duration:3 Hours |
Price: $290.00
| View Details
- 9
- February
- 2021
- Tuesday
Trends in FDA Compliance and Enforcement for Regulated Systems
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:90 Minutes |
Price: $150.00
| View Details
- 9
- February
- 2021
- Tuesday
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
- 10
- February
- 2021
- Wednesday
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
- 11
- February
- 2021
- Thursday
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
- 11
- February
- 2021
- Thursday
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug.
Roger Cowan |
Duration:60 Minutes |
Price: $150.00
| View Details
- 11
- February
- 2021
- Thursday
Say Goodbye to NAFTA: The USMCA is Now Here
The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes. The United States-Mexico-Canada Agreement (USMCA), commonly referred to as the "New NAFTA," is essentially “NAFTA 2.0".
Martin K. Behr, III |
Duration:90 Minutes |
Price: $150.00
| View Details
- 11
- February
- 2021
- Thursday
Risk Management - Implementing ISO14971: 2019
Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.
Yuval Shapiro |
Duration:60 Minutes |
Price: $150.00
| View Details
- 15
- February
- 2021
- Monday
FDA's New Import Program for 2020 and Impact of the COVID-19
In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Casper Uldriks |
Duration:60 Minutes |
Price: $150.00
| View Details
- 16
- February
- 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
- 17
- February
- 2021
- Wednesday
Writing Excellent SOPs
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Susanne Manz |
Duration:90 Minutes |
Price: $150.00
| View Details
- 17
- February
- 2021
- Wednesday
Allergen Cleaning, Validation & Preventative Risk Management
Allergen mishaps in manufacturing are now a Class I Recall by the FDA (Food & Drug Administration), considered an adulterant in foods.
Gina Reo |
Duration:60 Minutes |
Price: $150.00
| View Details
- 17
- February
- 2021
- Wednesday
Surviving OSHA Audit in Six Easy Steps
Learn how to quickly spot violations in the workplace and how to correct them to OSHA standards by attending this webinar.
Deidre Tate |
Duration:90 Minutes |
Price: $150.00
| View Details
- 17
- February
- 2021
- Wednesday
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
- 18
- February
- 2021
- Thursday
Quality Control for Analytical Materials used in Microbiology Laboratories
Method validation and method verification are two distinct procedures required to comply with ISO/IEC Standard 17025 for a microbiology laboratory accreditation. Unfortunately the two terms are often used interchangeably with serious consequences.
Michael Brodsky |
Duration:60 Minutes |
Price: $150.00
| View Details
- 18
- February
- 2021
- Thursday
FDA's Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data
This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry.
Carolyn Troiano |
Duration:90 Minutes |
Price: $150.00
| View Details
- 18
- February
- 2021
- Thursday
The Foreign Corrupt Practices Act: What Every U.S. Businessperson Must Know
The FCPA makes it unlawful for any U.S. citizen or firm (or any person who acts on behalf of a U.S. citizen or firm) to use a means of U.S. interstate commerce to offer, pay, transfer, or authorize a payment, transfer, or promise of money or anything of value to any foreign appointed or elected official, foreign political candidate, or candidate for a foreign political office for a corrupt purpose.
Martin K. Behr, III |
Duration:60 Minutes |
Price: $150.00
| View Details
- 18
- February
- 2021
- Thursday
The Transfer Of Validated Methods
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
John C. Fetzer |
Duration:60 Minutes |
Price: $150.00
| View Details
- 18
- February
- 2021
- Thursday
Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts
Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.
Angela Bazigos |
Duration:90 Minutes |
Price: $150.00
| View Details
- 18
- February
- 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
- 19
- February
- 2021
- Friday
FDA Inspections - Do's and Don'ts
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Jeff Kasoff |
Duration:60 Minutes |
Price: $150.00
| View Details
- 19
- February
- 2021
- Friday
3-Hour Virtual Seminar on Aseptic Technique and Cleanroom Behavior - Avoiding Human Error
Aseptic techniques are used to create compounded sterile products. In Microbiological term; Aseptic technique refers to prevention of microorganism contamination.
Danielle DeLucy |
Duration:3 Hours |
Price: $290.00
| View Details
- 19
- February
- 2021
- Friday
C for Yourself: The 5 C's of Credit
The first four C's-capacity, conditions, collateral, and character- evaluate a borrower's ability to repay, but character forces the lender to examine closely the borrower's willingness to repay.
Dev Strischek |
Duration:60 Minutes |
Price: $150.00
| View Details
- 19
- February
- 2021
- Friday
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
- 22
- February
- 2021
- Monday
Validation and Use of Excel Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Dr. Ludwig Huber |
Duration:75 Minutes |
Price: $150.00
| View Details
- 23
- February
- 2021
- Tuesday
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.
Dennis Taylor |
Duration:60 Minutes |
Price: $150.00
| View Details
- 23
- February
- 2021
- Tuesday
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
- 23
- February
- 2021
- Tuesday
Medical device cybersecurity following latest FDA Guidance
The company must establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market.
Edwin Waldbusser |
Duration:60 Minutes |
Price: $150.00
| View Details
- 23
- February
- 2021
- Tuesday
Protecting Food Delivery Drivers and Consumers During Covid-19
In a 2018 meeting of the Association of Food and Drug Officials, home food delivery services drew great interest due to potential for driver services to result in consumer level food safety outbreaks because of the lack of industry and governmental food safety controls.
John Ryan |
Duration:60 Minutes |
Price: $150.00
| View Details
- 23
- February
- 2021
- Tuesday
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
- 24
- February
- 2021
- Wednesday
Food Security and Fraud-Are You Ready?
Traditional HACCP programs are designed to enhance food safety by addressing the risk of inadvertent contamination of food during production and processing. Mitigating the intentional contamination of food requires an approach beyond HACCP.
Michael Brodsky |
Duration:60 Minutes |
Price: $150.00
| View Details
- 24
- February
- 2021
- Wednesday
3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Casper Uldriks |
Duration:3 Hours |
Price: $290.00
| View Details
- 24
- February
- 2021
- Wednesday
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
- 25
- February
- 2021
- Thursday
Determining Sample Size: What Sample Size Should I Use?
The webinar will provide important considerations when selecting sample sizes for specific applications.
Steven Wachs |
Duration:90 Minutes |
Price: $150.00
| View Details
- 25
- February
- 2021
- Thursday
Food Supplier Auditing: A Four-Part Plan
You deal with hundreds of suppliers. And you need to make sure each and every one of them meet regulations and quality standards. How can you keep your eye on that many suppliers?
Gina Reo |
Duration:60 Minutes |
Price: $150.00
| View Details
- 25
- February
- 2021
- Thursday
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
- 25
- February
- 2021
- Thursday
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
- 26
- February
- 2021
- Friday
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
Advancements in technology have forced organizations to rethink business models.
Carolyn Troiano |
Duration:90 Minutes |
Price: $150.00
| View Details
- 26
- February
- 2021
- Friday
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
- 2
- March
- 2021
- Tuesday
Mobile Apps as Medial Devices
Some of these new mobile apps / software functions are specifically targeted to assisting individuals in their own health and wellness management.
John E Lincoln |
Duration:90 Minutes |
Price: $150.00
| View Details
- 2
- March
- 2021
- Tuesday
BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now
The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union.
Robert J. Russell |
Duration:90 Minutes |
Price: $150.00
| View Details
- 4
- March
- 2021
- Thursday
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications.
David Nettleton |
Duration:90 Minutes |
Price: $150.00
| View Details
- 5
- March
- 2021
- Friday
How Will FDA's New Approach to CSV Make Implementations Easier?
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Carolyn Troiano |
Duration:90 Minutes |
Price: $150.00
| View Details
- 9
- March
- 2021
- Tuesday
Effective Standard Operating Procedure (SOPs) Development
Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities.
Danielle DeLucy |
Duration:90 Minutes |
Price: $150.00
| View Details
- 9
- March
- 2021
- Tuesday
CAPA: Corrective and Preventative Actions and Non-Conformances
If, instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it.
Michael Brodsky |
Duration:60 Minutes |
Price: $150.00
| View Details
- 9
- March
- 2021
- Tuesday
Medical Device Complaints & CAPA
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing.
Edwin Waldbusser |
Duration:60 Minutes |
Price: $150.00
| View Details
- 9
- March
- 2021
- Tuesday
Regulatory Challenges of Real-world Artificial Intelligence (AI) and Machine Learning (ML)
This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.
Angela Bazigos |
Duration:90 Minutes |
Price: $150.00
| View Details
- 10
- March
- 2021
- Wednesday
Best Practices in Preparation for an FDA Computer System Audit
As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.
Carolyn Troiano |
Duration:90 Minutes |
Price: $150.00
| View Details
- 10
- March
- 2021
- Wednesday
Re-establishing Manufacturing Controls After the Pandemic Shutdown
Good manufacturing controls have been around for many years. They have helped companies go through the point in their growth cycle when the initial fly-by-night system they struggled to put in place as a young company no longer satisfy demands or schedules.
John Ryan |
Duration:90 Minutes |
Price: $150.00
| View Details
- 10
- March
- 2021
- Wednesday
Death By CAPA - Does your CAPA Program Need a CAPA?
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Susanne Manz |
Duration:90 Minutes |
Price: $150.00
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- 11
- March
- 2021
- Thursday
Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.
Roger Cowan |
Duration:60 Minutes |
Price: $150.00
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- 11
- March
- 2021
- Thursday
Creating Optimal Sampling Plans
A sampling plan is a term widely used in research studies that provide an outline on the basis which of research is conducted. It tells which category is to be surveyed, what should be the sample size and how the respondents should be chosen out of the population.
Yuval Shapiro |
Duration:60 Minutes |
Price: $150.00
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- 17
- March
- 2021
- Wednesday
Successful Deviation Investigations
Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit.
Danielle DeLucy |
Duration:60 Minutes |
Price: $150.00
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- 17
- March
- 2021
- Wednesday
Is it Microbiological Method Verification or Validation, or Just Semantics?
This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation in food/water microbiology.
Michael Brodsky |
Duration:60 Minutes |
Price: $150.00
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- 17
- March
- 2021
- Wednesday
Human Factors/ Usability Studies following ISO 62366 and the new FDA Guidance
Human Factors/ Usability is the analysis of how people interact with medical devices.
Edwin Waldbusser |
Duration:60 Minutes |
Price: $150.00
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- 17
- March
- 2021
- Wednesday
3-Hour Virtual Seminar on Project Management for Computer Systems Validation
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion.
Angela Bazigos |
Duration:3 Hours |
Price: $290.00
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- 18
- March
- 2021
- Thursday
How Blockchain Will Become the Basis for An Integrated Food Safety System (IFFS)
If you have been wondering what all this jazz about Blockchain is or how it might impact your position in the food supply chain, you need to take and hour to learn what's going on.
John Ryan |
Duration:90 Minutes |
Price: $150.00
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- 18
- March
- 2021
- Thursday
Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Ginette Collazo |
Duration:90 Minutes |
Price: $150.00
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- 22
- March
- 2021
- Monday
FDA Compliance for Mobile Applications
Attend this webinar to understand the FDA guidance for mobile applications.
Eleonora Babayants |
Duration:60 Minutes |
Price: $150.00
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- 24
- March
- 2021
- Wednesday
Cybersecurity - US FDA Requirements
Due to the growth of the cybersecurity threat to electronic records, computer-controlled manufacturing, and medical devices, the US FDA has issued Guidances for Industry, e.g.: 1) "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software Document”, and 2) "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", and 3) "Postmarket Management of Cybersecurity in Medical Devices" - Draft.
John E Lincoln |
Duration:90 Minutes |
Price: $150.00
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- 25
- March
- 2021
- Thursday
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
David Nettleton |
Duration:75 Minutes |
Price: $150.00
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- 25
- March
- 2021
- Thursday
Biosafety And Blood-Borne Pathogen Safety In The Lab
This webinar will provide you with the regulatory framework and recommended guidelines, risk assessment for biological materials, structure of a robust biosafety program and on how to train employees exposed to biological hazards.
Danielle DeLucy |
Duration:60 Minutes |
Price: $150.00
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- 25
- March
- 2021
- Thursday
European Union Device Regulation (EU MDR)
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".
Edwin Waldbusser |
Duration:60 Minutes |
Price: $150.00
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- 25
- March
- 2021
- Thursday
The EU Medical Device Regulation (MDR 745/2017) - The New Process to Enter the European Market
The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing.
Yuval Shapiro |
Duration:60 Minutes |
Price: $150.00
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- 25
- March
- 2021
- Thursday
3-Hour Virtual Seminar on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science".
Angela Bazigos |
Duration:3 Hours |
Price: $290.00
| View Details
- 30
- March
- 2021
- Tuesday
Data Integrity - US FDA Requirements
Due to the growth of electronic records and electeronic signatures in CGMP documentation, as well as computer-controlled manufacturing, and medical devices, the US FDA has issued a draft Guidance for Industry, outlining its expectations for increased data integrity in this changing environment.
John E Lincoln |
Duration:90 Minutes |
Price: $150.00
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- 30
- March
- 2021
- Tuesday
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
- 31
- March
- 2021
- Wednesday
The Identification And Quantitation Of Low-Level Compounds For Impurity And Degradation Analyses
In this webinar attendees will learn the impurity and degradation product analyses tests on compounds of low concentrations for Identification and Quantitation.
John C. Fetzer |
Duration:90 Minutes |
Price: $150.00
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- 13
- April
- 2021
- Tuesday
Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement.
Roger Cowan |
Duration:60 Minutes |
Price: $150.00
| 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
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