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Medical Device Software: Verification, Validation & Compliance
This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval ...
- Basic & Advanced
- 60 Mins
- Nancy Knettell
- May 23, 2019
Onboarding New or Transferred Employees in a GMP Environment
The objective of the course is to enable attendees to: Define the onboarding process in the context of regulatory compliance Interact with Human Resources to create a coordinated onboarding strategy that covers both their requirements and quality requireme ...
- Intermediate
- 90 Mins
- Michael Esposit
- May 28, 2019
Implementing a Robust Data Integrity Program
Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on the topic during co ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
- Jun 04, 2019
Technical Writing: A Detailed Process
Provides step-by-step instructions to produce excellent written presentations Learn how to balance between being precise enough to cover the subject matter yet general enough to apply to other locations and/or projects Learn how to deal with reviewers and ...
- Basic & Intermediate
- 60 Mins
- Robert Peoples
- Jun 04, 2019
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented w ...
- Basic & Intermediate
- 90 Mins
- Joy L. McElroy
- Jun 05, 2019
Adopting Price Controls for U.S. Prescription Drugs: Federal Policy Outlook for 2019 & Beyond
The cost of prescription drugs in the United States remains a hot-button issue for policymakers and consumers alike The vast majority of the public sees drug prices as unreasonably high with one in four people taking prescription drugs reporting difficulty ...
- Basic & Intermediate
- 60 Mins
- Dennis Weissman
- Jun 06, 2019
The Importance of Packaging and Labeling in Pharmaceutical Product Development
Pharmaceutical and life sciences companies are under an extreme amount of pressure to maintain an ever-increasing amount of regulation and legislation. With this pressure, they still need to increase efficiencies, bring new products to the market faster, re ...
- Basic & Intermediate
- 60 Mins
- Michael Esposit
- Jun 06, 2019
Cannabinoids as Drugs
This webinar will discuss the current status of cannabinoids as medical products in the United States. The focus will be on what we can learn from the FDA approval of Epidolex (Cannabidiol) oral solution 100 mg/mL. How to obtain research information will be pr ...
- Basic & Intermediate
- 90 Mins
- Loren Gelber
- Jun 06, 2019
FAA Drug and Alcohol Testing Requirements - How to Comply with Title 14 Code of Federal Regulations (CFR) part 120 and 49 CFR Part 40
This webinar will provide an emphasis on how to easily understand the FAA requirements relative to drug and alcohol testing and how to prepare for an FAA audit of an FAA approved Drug and Alcohol program. Federal Aviation Authority (FAA) regulations 14 CFR Pa ...
- Basic & Intermediate
- 60 Mins
- Mont Smith
- Jun 06, 2019
Effective Batch Record Review
In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of ...
- Intermediate
- 60 Mins
- Danielle Delucy
- Jun 11, 2019