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November 15, 2024

Reducing Lyophilization Time and Increasing Product Stability

November 1, 2024

November 2024 Newsletter

AVS Life Sciences - A Corporate Perspective

Artificial Intelligence & Machine Learning in Biopharmaceutical Engineering: A Woman's Perspective

Accelerating Batch Record Reviews with Electronic Batch Records

Navigating Medical Device Regulations: EU MDR vs. US QSR and the Role of Digitization

September 16, 2024

Batch Processing Integration

Cell & Gene Therapy

November 15, 2023

Fill Finish

QC Lab Study

November 29, 2023

Artificial Intelligence: Regulatory Affairs Evolution Utilizing AI

September 20, 2023

Right Sizing Computer System Validation in Life Sciences

Cell and Gene Therapy: Manufacturing and Development Challenges

Inhalation Sciences

Medical Devices - EU MDR Compliance

August 11, 2021

The Essence of Good Laboratory Practices (GLP): What You Need to Know

Inhalation Drug Development Process Overview

Remote Auditing: Best Practices and Practical Suggestions

January 15, 2020

What to Expect in an FDA Inspection: CPGM-Updated PAI Guide

November 13, 2019

Keeping up with Regulations: Good Clinical Practice ICH E6(R2)

September 25, 2019

Data Integrity: The Roadmap to Compliance

Investigation Deviations and Non-Conformances

Management Review and Quality Metrics

Quality Culture

Quality Agreements

February 12, 2019

Qualifications and Oversight of Contract Service Providers

January 29, 2019

Key Elements of Virtual Life Sciences Companies

The top 8 pharmaceutical consulting firms you should consider for 2024

AVS-MWA among Qualio’s 9 top medical device consulting firms you should consider for 2024

February 15, 2024

FDA Guidance: Quality Considerations for Ophthalmic Drug Products

January 23, 2024

FDA Launches New Webpage for Searching Pharmaceutical Quality Documents

January 16, 2024

FDA Draft Guidance on 510(k) Submissions and EUA Requests

January 4, 2024

Automation & Validation Solutions, LLC Acquires MWA Consulting, Inc.

November 1, 2023

FDA Draft Guidance on the Agency’s Continued Use of Remote Evaluations

October 3, 2023

FDA Published Draft Guidance on Electronic Submission Template for Medical Device De Novo Requests

September 28, 2023

CDER’s Quality Management Maturity Program

August 31, 2023

FDA’s Informed Consent Regulations for Clinical Investigations

August 16, 2023

Process Checklist for Computer System Validation (CSV)

FDA Published Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry

FDA Paper on Artificial Intelligence in the Manufacture of Medicines

FDA Published Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices

FDA Published Patient-Focused Drug Development Guidance Document

FDA Issued Guidance to Help Identify Suspect and Illegitimate Product

FDA Publishes Guidance on a Risk-Based Approach to Monitoring Clinical Investigations

ECA GMP Equipment Design Guide

FDA Released Recommendations that Assist in the Development of Monoclonal Antibodies

February 21, 2023

Guidance Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products from FDA

February 16, 2023

Manufacturing Execution Systems (MES) Methodology

February 14, 2023

Draft Guidance for M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms

February 7, 2023

The Impact of Clinical Trial Decentralisation on the Pharma Supply Chain

Upcoming Events

Find us at these industry events throughout the year.

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San Francisco, CA

January 14, 2025

San Francisco, CA

January 27, 2025

2025 ISPE Facilities of the Future Conference