![](/images/products/large/705544.jpg)
Deciding When to Submit a 510(k) for a Change to an Existing Device - FDA's Final Guidance
Angela Bazigos
3 hrs
Product Id: 705544
This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., “existing devices”) during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).
![](/images/products/large/705506.jpg)
Bioavailability and Bioequivalence Studies submitted in NDAs and INDs
Stephanie Cooke
90 Min
Product Id: 705506
Attendees that need to perform bioavailability (BA) and bioequivalence (BE) studies for INDs, NDAs or for NDA supplements should attend this training. They will learn the requirements of such studies, per 21 CFR 320 and all other relevant regulatory documents.
![](/images/products/large/705488.jpg)
How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)
Angela Bazigos
90 Min
Product Id: 705488
Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?
![](/images/products/large/705432.jpg)
Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity
Edwin Waldbusser
60 Min
Product Id: 705432
This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.
![](/images/products/large/705477.jpg)
Ensure successful FDA/Global Site Inspections and Maximize Potential Regulatory Opportunities by establishing effective Pharmaceutical Quality System (per ICH Q10 guidance document)
Stephanie Cooke
90 Min
Product Id: 705477
This webinar will discuss the requirements for handling deviation based on GMPs, ICH guidance documents and other relevant guidance. It will also explain ICH Q8, Q9, and Q10 guidance documents and will provide best practices to ensure compliance with these documents in regards to handling deviations and nonconforming products.
![](/images/products/large/705520.jpg)
3.5 hr Virtual Boot Camp: How to Survive an FDA Food Facility Inspection
Angela Bazigos
3.5 hrs
Product Id: 705520
This Virtual Boot Camp will provide an overview of the FDA inspection program, how to prepare for an inspection of your facility and the FDA program that applies to foreign food facility inspections.
![](/images/products/large/702277.jpg)
Changing Supplier Controls Requirements
John E Lincoln
60 Min
Product Id: 702277
This training on FDA supplier controls will help you refine your supplier chain management and vendor audits to match the FDA's tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program.
![](/images/products/large/705057.jpg)
How to Conduct a Human Factors Validation Following ISO 62366 and the 2016 FDA Guidance
Edwin Waldbusser
60 Min
Product Id: 705057
This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.
![](/images/products/large/703738.jpg)
Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts
Angela Bazigos
90 Min
Product Id: 703738
This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.
![](/images/products/large/705412.jpg)
Risk Based Approach in cGMP - Quality Risk Management (QRM)
Shana Dressel
60 Min
Product Id: 705412
This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.
![](/images/products/large/705346.jpg)
FDA Inspections: What Regulations Expect
Joy McElroy
90 Min
Product Id: 705346
Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.
![](/images/products/large/705448.jpg)
Managing Communication in a Crisis and Protecting Your Brand
Michael Barrio
60 Min
Product Id: 705448
This webinar will focus on the effective crisis communication strategies. Attendees will learn best practices to protect their organization’s brand in the time of crisis.
![](/images/products/large/705329.jpg)
Introduction to Medical Communications - Medical Writing Careers in Pharma
Anne E Maczulak
60 Min
Product Id: 705329
This webinar will focus on the specific types of writing responsibilities available in industry. It will help attendees understand the medical writing profession and in determining if medical writing or technical writing is a good fit for each of them.
![](/images/products/large/705336.jpg)
Reduce Inspection Costs with Sequential Sampling
William Levinson
60 Min
Product Id: 705336
This webinar will explain how to use ANSI/ASQ Z1.4 to define sampling plans including its switching rules. It will also offer an inspection plan format that reduces the sequential sampling plan to ten or fewer rows in most cases.
![](/images/products/large/702152.jpg)
Going Global: Best Practices for Integrating Business Development and Regulatory Compliance (life science focus)
Robert J Russell
90 Min
Product Id: 702152
This 90 minute webinar will present regulatory compliance considerations and regional differences for regulated and/or registered products for the U.S., Canada, the EU, Latin America and countries in the Asia / Pacific rim, to make the expansion to that region a success.
![](/images/products/large/705288.jpg)
21 CFR 111 GMP Dietary Supplement Laboratory
Gwen Wise Blackman
60 Min
Product Id: 705288
This training program will provide an overview of 21 CFR 111 regulatory requirements which governs how dietary supplements are manufactured and tested. It will futher review the test procedures and documentation requirements to ensure regulatory compliance.
![](/images/products/large/701022.jpg)
Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Operations
Jim Polarine
90 Min
Product Id: 701022
This webinar will discuss the details of specific excursion investigation for outbreaks of molds, vegetative bacteria, and Bacillus.
![](/images/products/large/705323.jpg)
FDA Import Alert - 2017
Casper Uldriks
60 Min
Product Id: 705323
This webinar will cover US FDA and Customs legal import requirements including discussion on FDA product codes, Custom's Harmonized Tariff Schedule (HTS) and Affirmation of Compliance (AOC). It will also provide information on FDA's software screening program, PREDICT, and U.S. Custom's ACE program.
![](/images/products/large/700322.jpg)
Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data
Jeff Kasoff
60 Min
Product Id: 700322
This webinar will provide valuable assistance to all regulated companies; a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
![](/images/products/large/705322.jpg)
Using Open Access - Finding Trustworthy Online Resources
Anne E Maczulak
90 Min
Product Id: 705322
This webinar will focus on most trustworthy open access resources. It will also provide tips on how to gain access to hard-to-find materials by paying high subscription or membership fees.