Compliance

Establishing Commercial Manufacturing Services for Antibody-Drug Conjugates

Learn how to properly structure your development work, perform a thorough process risk assessment and prepare for pre-approval inspection audit.

Sponsored released by MilliporeSigma 06.09.21

Inspections | Validation

From Capital Builds to Staff Augmentation: Tips to Achieving Integrated CQV Strategies

An integrated CQV strategy can support current projects and ongoing operations. This webinar will cover integration strategies in several key areas.

06.09.21

Information Technology | QA/QC | Regulatory Affairs

The Importance of Data Integrity Risk Assessment

Executing Data Integrity Risk Assessments for systems that generate and store both paper (manual)-based systems as well as computer-based and hybrid systems.

Paul Mason, Ph.D., Lachman Consultants 06.07.21

Breaking News | Facilities | Industry News | Inspections

CPL Completes Successful Virtual Health Canada Audit

The CDMO created a virtual tour of its facilities in response to the pandemic.

Tim Wright, Editor, Contract Pharma 06.03.21

Regulatory Affairs

Meeting with the FDA: Valuing the Statistician and Preparation for Review

A look at the key roles and responsibilities of FDA and biopharmaceutical industry statisticians throughout product lifespan.

Joshua Baker, VP and LaRee Tracy, PHASTAR 05.27.21

ADMA Receives FDA Approval for Increased IVIG Production Scale

Increases plant manufacturing capacity from 400,000L to 600,000L.

Tim Wright, Editor, Contract Pharma 04.29.21

Breaking News | Facilities | Industry News | Inspections

Bora Pharmaceuticals Completes Health Canada Inspection

Mississauga site is the company’s first manufacturing facility in North America and is its HQ in the region.

Tim Wright, Editor, Contract Pharma 04.23.21

Clinical Trials | R&D | Regulatory Affairs

Unifying Quality Manufacturing to Drive Speed, Collaboration, and Compliance

Learn how you can unify end-to-end quality management to improve visibility, efficiency, and compliance in this webinar on May 13.

04.22.21

Jubilant HollisterStier CMO

Jubilant HollisterStier Contract Manufacturing & Services is an integrated contract manufacturer of sterile injectables, ophthalmics, otics and sterile and non-sterile topicals and liquids.

Marcy Edwards, Marketing Manager 04.16.21

cGMP Manufacture | QA/QC

Ensuring Pharma Manufacturing Quality

How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.

Online Exclusives Kristin Brooks, Contract Pharma 04.14.21

Biologics, Proteins, Vaccines | Regulatory Affairs

What Will Change at FDA for 2021?

(R)evolution of the industry’s data, catalyzed by changes at FDA and what’s the likely impact to the pharmaceutical industry?

Ben Locwin, Contributing Editor, International COVID-19 Advisor, Healthcare Futurist 04.01.21

Clinical Trials | Drug Development | QA/QC

RBQM Comes of Age: COVID as a Catalyst for Change

Clinical trial conduct has undergone a fundamental shift over the last year – and things will never be the same again.

Online Exclusives Kristin Brooks, Managing Editor 04.01.21

Regulatory Affairs

Post-Pandemic Regulations

Envisioning clinical development regulatory practices in a post-pandemic world.

Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA 04.01.21

Enteris BioPharma: Custom Solutions – From Bench to Market

CDMO operations are housed within a 32,000-square-foot, FDA-inspected and cGMP-compliant facility in northern New Jersey.

Sponsored released by Enteris BioPharma 04.01.21

Breaking News | cGMP Manufacture | Industry News | Inspections

Metrics Contract Services Completes Russian Regulatory Inspection

Greenville, NC site approved to make an oncology drug to be marketed in Russia.

Tim Wright, Editor, Contract Pharma 03.09.21

Validation

Guide to Maintaining Validation of Older Facilities: Why, When and How

This guide explains some of the most common challenges found in aging facilities, tips for identifying when a facility requires revalidation and more.

Biologics, Proteins, Vaccines | Regulatory Affairs

The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to “normalcy.”

Chad Landmon, Michelle Divelbiss and Alex Alfano, Attorneys - Axinn, Veltrop & Harkrider LLP 01.27.21

Breaking News | Drug Development | Industry News | Information Technology | Regulatory Affairs

Top BioPharma Form Accumulus Synergy

Aims to develop a cloud-based Global Data Sharing Platform to facilitate data and information sharing between industry and health authorities worldwide.

Kristin Brooks 01.22.21

Breaking News | Industry News | Information Technology | Validation