Subject: QA/QC

FDA 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

Packaging 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

Drug Product Stability and Shelf-Life

Every drug product must undergo sufficient stability testing before it can be introduced to the market. While ICH has standardized and harmonized the stability testing process, there are still numerous challenges that need to be addressed to ensure that stability testing is conducted accurately. Inadequate stability testing can cause delays in product introduction, which is… Continue reading Drug Product Stability and Shelf-Life

Pharmaceutical Process Development

This course is designed to provide a basic understanding of the significant process development effort involved in taking an R&D laboratory formulation to commercial production. This course will focus on two main areas: How to develop a pilot process suitable for scale-up to commercial production. Factors to consider during scale-up and technology transfer to take… Continue reading Pharmaceutical Process Development

Writing 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

Qualification 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)

Beatrice Huey

Beatrice Huey is a Good Tissue Practice Specialist at the University of Arkansas for Medical Sciences in Little Rock, Arkansas. She has over 20 years of experience working in FDA-regulated environments and the tissue industry. She has extensive knowledge of current good tissue practice (CGTP), good manufacturing practices (CGMP), and good laboratory practice (GLP). She… Continue reading Beatrice Huey

John O’Neill

John O’Neill earned his Bachelor’s degree in Pharmaceutical Sciences from Columbia University and a Master’s in Health Systems Management from Union University. His career of 43 years has taken him from Registered Pharmacist to-Liquids and Semi-solids Formulator at Sterling Winthrop, QC Manager at Sanofi-Aventis, Medical Device Quality Steward at Boston Scientific, Independent Consultant, Principal Stability… Continue reading John O’Neill

Charity 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

Bonnie M. Pappacena

Bonnie Pappacena is the President of Qualture LLC, a quality consulting firm committed to building quality into company culture. Ms. Pappacena has been a quality professional for over 35 years, spanning the animal health, biological, chemical, device, generic, and pharmaceutical industries. She possesses hands-on experience conducting and managing audits in GCP, GLP, GMP (clinical supplies… Continue reading Bonnie M. Pappacena