Susan J. Schniepp

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Maintaining compliance to compendial requirements should be straightforward, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

The more information shared, the smoother the approval process, says Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.

A contamination control strategy should provide an overview of how contamination and containment practices work together to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

A risk assessment should be performed as part of the CAPA process, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating analytical methods.

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, provides simple answers to frequently asked questions regarding batch records.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, addresses the difference between regulatory compliance and real compliance.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about biologics license applications.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, provide answers to frequently asked regulatory questions about advanced therapy medicinal products.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about regulatory filings.

Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding deviation investigations.

Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding regulatory inspections, although many of the concepts can be applied to internal and supplier audits as well.

With appropriate planning and the proper use of technology, remote auditing can be as effective and informative as in-person auditing.

Virtual audits, virtual training, and more robust quality agreements may become positive impacts on the industry, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

The amount of detail included in SOPs may help a company stay compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, LLC.

When in-person training may not be feasible, there are still opportunities to ensure employees receive the required training, says Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

Products must be manufactured in accordance with appropriate regulatory requirements, even during a pandemic, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Addressing data integrity, quality culture, aging facilities, investigations/corrective actions and preventive actions, and risk management is key when conducting audits, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.

ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products

Investigating deviations of combination products needs to accommodate both the drug and device components, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.