The research, development, manufacturing, and regulatory approval of new biotechnology and biopharmaceutical products often presents novel challenges for which a background in conventional pharmaceuticals offers little guidance.
To bridge this gap between academic instruction and the real-world complexities of research, development, validation, regulations, processing, and manufacturing, we provide practical, specialized training by industry experts. With ever-changing scientific understanding and government regulations, it’s critical that you have the most current information possible – training with COBBLESTONE ensures you will.
How to Manage and Prepare for a Pre-Approval Inspections (PAI)
The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control. Many times, the arrival of a… Continue reading How to Manage and Prepare for a Pre-Approval Inspections (PAI)
Read MoreManaging Standard Operating Procedures (SOPs) in the FDA Regulated Environment
Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible.… Continue reading Managing Standard Operating Procedures (SOPs) in the FDA Regulated Environment
Read MoreHandling OOS Test Results and Completing Robust Investigations
It was the Barr Decision in the early 1990s that first coined the term Out-of-Specification (OOS). Since that landmark case, pharmaceutical companies, both drug and biologicals, have had to perform adequate investigations whenever an OOS result was obtained through laboratory testing. In the nearly 30 years since then, FDA continues to cite companies for not… Continue reading Handling OOS Test Results and Completing Robust Investigations
Read MoreBasics of Microbiology
For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Basics of Microbiology
Read MoreRequirements for Aseptic Techniques and Practices
For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes… Continue reading Requirements for Aseptic Techniques and Practices
Read MorePackakaging Design: Designing a Package to Maximize Product Impact
A package can mean the difference between proper dosing or failure to follow a drug regimen. It can build product loyalty or drive a user to switch to a different offering. It can also mean profitable manufacturing or a cost of goods headache. At the conclusion of this 90-minute accredited training, you will understand the… Continue reading Packakaging Design: Designing a Package to Maximize Product Impact
Read MoreFDA Inspection Essentials: Key Dos and Don’ts
The purpose of the Regulatory Inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control. Many times, the arrival of a… Continue reading FDA Inspection Essentials: Key Dos and Don’ts
Read MoreLaboratory Controls Overview & Establishment of Specifications
In FDA’s Guide to Inspections of Pharmaceutical Quality Control Laboratories (7/93), it is stated The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. Consistent with current Good Manufacturing… Continue reading Laboratory Controls Overview & Establishment of Specifications
Read MoreAnalytical Methods Validation – 21CFR211.165(e)
One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products today is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this to the drug development process… Continue reading Analytical Methods Validation – 21CFR211.165(e)
Read MoreStability Testing – 2 CFR 211.166 (a & b)
In 2006, FDA withdrew both their approved 1987 Stability Guideline and their draft 1998 Stability Guidance and referred industry to the ICH Stability Guidances. In the absence of the detailed FDA guidelines, industry was left to interpret the somewhat ambiguous GMPs. The fact that stability issues continue to be a major cause for regulatory action… Continue reading Stability Testing – 2 CFR 211.166 (a & b)
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