FDA Compliance
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Artificial Intelligence (AI) Algorithms as Medical Devices – Regulatory Requirements
This webinar will discuss the impact of incorporating Artificial Intelligence based algorithm on the premarket regulatory requirements from medical devices and healthcare products. The regulatory requirements associated with AI based software as medical device products will be mapped and... -
Artificial Intelligence in Pharmaceutical GMP Operations – Case Studies
This latest webinar will showcase possibilities with some case study examples of what can be done. The case study for manufacturing, maintenance, instrumentation, Quality assurance and regulatory assurance functions will be discussed. It is a must attend webinar to... -
Aseptic Process Overview and Validation
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors. Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a... -
Aseptic Processing and Techniques 101
Many of the drug products manufactured for use are injected into our bodies. By avoiding our first line of defense against infection, any possible source of infection can wreak havoc on our immune systems. In order in insure our... -
Auditing 101
The Course clarifies the role of the new auditor or internal auditor and explains their responsibilities. The session will also discuss interactions with others in key roles as part of the audit as well as exploring some techniques used... -
Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach
This training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities... -
Auditing Computer Systems for FDA and International Compliance
With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic... -
Auditing Computer Systems for FDA and International Compliance
With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic... -
Auditing for Microbiological Aspects in Pharmaceutical Manufacturing
The seminar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing... -
Auditing Laboratory Data Systems
The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met. This webinar will provide details of the most common non-conformances and provide staff members, who are unfamiliar with... -
Auditing Laboratory Data Systems
The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met. This webinar will provide details of the most common non-conformances and provide staff members, who are unfamiliar with... -
Sale!
Avoid Reporting Cybersecurity Updates and Patches to the FDA
Is a cybersecurity patch or update a reportable event under the Reports of Corrections and Removals regulation? (21 CFR Part 806) The FDA issued a guidance document recently entitled, “Postmarket Management of Cybersecurity in Medical Devices.” It explains that... -
Avoiding 483’s Throughout your Organization – Strategies, Risk and Mitigating Approaches
Certainly the most simplistic solution to achieving compliance excellence and 483 avoidances is “to do the right things right!” But what does this really mean? I have distilled the “doing the right things right” solution into 7 separate individual... -
Basic Requirements for IQ, OQ and PQ Quality Protocols
Current regulatory requirements state the need to prove equipment, systems and utilities are verified to perform their desired functions. This verification comes in the form of qualification protocols that verify proper installation, operation over its entire range, and acceptable... -
Best Practices For A Compliant, Lean Supplier Management Program
Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meet all... -
Best Practices in Preparation for an FDA Computer System Audit
The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and...
