Medical devices span the therapeutic spectrum, from the toothbrush to life-saving heart implants. Even in simple devices, complex engineering challenges can arise that must balance mechanical, biological, regulatory, and other factors.
Frequent training is necessary to stay current on the practical demands of adhering to medical device regulations and validation processes, and helps ensure your manufacturing process will produce devices that conform to the approved design characteristics.
The QbD Toolbox
If you are charged with exploring or implementing a QbD effort within your organization, where do you begin? Available guidance documents do not provide all of the information necessary to effectively implement such a program. Without a proper understanding of how to establish QbD, your efforts may fail. This accredited training course presents methods that… Continue reading The QbD Toolbox
Read MoreQualification and Management of CMOs (Contract Manufacturing Organizations)
Every pharmaceutical company hopes to obtain its desired expectations when it comes to important relationships with their outsourcing partners. This intensive course examines the root causes of critical issues that can arise within these relationships, which are much broader and deeper than the technical capability to perform a process. This course examines the strategic and… Continue reading Qualification and Management of CMOs (Contract Manufacturing Organizations)
Read MoreWriting and Enforcing SOPs: Best Practices for Regulated Industries
Organizations often face challenges when creating and enforcing effective standard operating procedures (SOPs). Poorly written SOPs are a common cause of deficiencies and observations mentioned in 483s and warning letters issued by the FDA. Therefore, companies operating in regulated industries must understand how to organize and present information for the intended audience and purpose. To address… Continue reading Writing and Enforcing SOPs: Best Practices for Regulated Industries
Read MoreSterile Products
Parenteral product development and aseptic manufacturing can be intimidating to people new to the topics. The approach to formulation and process development is substantially different than for oral and topical medications. Product development and manufacturing must consider how all of the manufacturing processes align to ensure chemical, physical, and microbiological stability with particular attention to… Continue reading Sterile Products
Read MoreQuality Management and Compliance in the Pharmaceutical and Related Industries
Under the global regulator-based inspection approach, the Quality system is one that is routinely audited. Quality issues are a huge factor in inspection observations leading to recalls for drugs, biologics, and medical devices. This indicates that not all companies are meeting current GMP expectations. Clearly a better understanding is needed to overcome this trend and… Continue reading Quality Management and Compliance in the Pharmaceutical and Related Industries
Read MorePackaging Pharmaceuticals, Medical Devices, and Combination Products
The importance of a product’s primary package cannot be overstated. From material selection to closures to stability to the packaging process itself, a multitude of critical decisions must be made in order to develop a quality package. Shortcomings or a lack of understanding of any of these important considerations can render a final package unacceptable.… Continue reading Packaging Pharmaceuticals, Medical Devices, and Combination Products
Read MoreFDA Inspection Readiness Certification Program
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading FDA Inspection Readiness Certification Program
Read MoreSterilization Professionals Certification Program
In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that manufacturers of… Continue reading Sterilization Professionals Certification Program
Read MoreCharity Ogunsanya
Charity Ogunsanya has more than 30 years of extensive experience within the biologics, pharmaceuticals, radiopharmaceuticals, biotechnology, and medical device industries and has been the Microbiology, Sterility Assurance, Contamination Control, Aseptic processing, Quality Control Subject Matter Expert (SME) for multiple fortune 100 companies. She has a Bachelor of Science degree in Microbiology from the University of… Continue reading Charity Ogunsanya
Read MoreJan Gates
Jan Gates has 30+ years of experience in package engineering for foods, pharmaceuticals, detergents, and medical devices, with a BS in Food Science and an MS in Packaging from Michigan State University. Her work includes individual contributions and leading teams for packaging material and systems design and development. The packaging design and development have been… Continue reading Jan Gates
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