24 July 2026, 3:00-4:00 PM EDT

SQA Webinar: The Role of Artificial Intelligence in Drug Product Development: Through an FDA Lens

Presented by:  Bhasker Sambar, Alvogen Inc.

Webinar Category: Regulatory

Regulatory Area of Interest: GMP

Description:
The pharmaceutical industry is rapidly evolving toward Pharma 4.0, where artificial intelligence (AI), digital twins, predictive analytics, and real-time process monitoring are transforming how drug products are developed and manufactured. This webinar will introduce the concept of digital twins in pharmaceutical manufacturing and explain how virtual process models can improve product quality, manufacturing efficiency, deviation reduction, and regulatory compliance.

The session will provide practical examples from sterile injectables, suspension products, and continuous manufacturing environments, highlighting how digital twins can support process optimization, scale-up, root cause investigations, and commercial manufacturing reliability. Attendees will also gain insight into FDA expectations, data integrity considerations, GMP implications, and future opportunities for AI-enabled autonomous pharmaceutical manufacturing.

This webinar is intended for pharmaceutical professionals working in Quality Assurance, Manufacturing, Process Development, Regulatory Affairs, Validation, and Pharmaceutical R&D who are interested in understanding the future of smart manufacturing and digital transformation in the pharmaceutical industry

RQAP Re-registration units approved:  1 GMP | non-GCP | non-GMP

Register to Attend

11 August 2026, 12:00-1:00 PM EDT

SQA Webinar: Early Career Insights: Debunking Myths and Revealing Truths

Presented by:

Taylor Egbert, Charles River Laboratories

Mayra Herrera, Inotiv

Webinar Category: Soft Skills

Description:
Our topic offers a practical and candid exploration of the lessons many professionals wish they had learned sooner. This presentation challenges common misconceptions about career growth—such as the importance of having everything figured out early, the myth of linear career paths, and the belief that hard work alone guarantees success.

Through real-world experiences and actionable advice, it highlights key insights on navigating workplace dynamics, building meaningful networks, embracing continuous learning, and advocating for personal and professional growth. Attendees will gain a clearer understanding of what truly matters in the early stages of a career and leave with strategies to make more informed, confident decisions moving forward.

RQAP Re-registration units approved: 1 non-GCP | non-GLP | non-GMP

Register to Attend

18 August 2026, 1:00-2:00 PM EDT

SQA Webinar: Maintaining Your TMF in an Inspection Steady State

Presented by:  Dawn Niccum, inSeption Group

Webinar Category:  Compliance

Regulatory Area of Interest:  GCP

Description:
The Trial Master FIle is a key deliverable in a clinical trial. The records in the TMF should support all key decision making, oversight and conduct of the trial. Organizations struggle to ensure their TMF always ready for an inspection ("inspection steady"). This webinar will discuss approaches QA can support to an ensure an "inspection steady" TMF.

RQAP Re-registration units approved: 1 GCP | non-GLP | non-GMP

Register to Attend

24 August 2026, 12:00 - 1:00 PM EDT

SQA Connect Lounge Series: Ethics and/or/versus Compliance Session 2 - Good Laboratory Practices

Presented by: Deborah Randall-Hlubek, Consultant; Cat Bens

Moderated by: Kamila Novak, KAN Consulting MON. I.K.E.

Webinar Category: Compliance

Regulatory Area of Interest: GLP

This is part of a series of Connect Lounges focusing on Ethics and/or/versus Compliance. More information about future topics can be found below.

No matter how much we wish ethics and compliance were always aligned, every now and then we encounter grey zones and dilemmas, and the way forward is not so clear and obvious. This Connect Lounge series will explore case studies from various GXP areas (GCP, GLP, GMP, GVP, AI and overarching). Moderators will discuss 2-3 case studies per Lounge, and will ask attendees four basic questions:

1.  Is there a potential compliance issue?
2.  Is there a potential ethical issue?
3. How would you analyze the root cause(s)?
4. What would you do in this situation?

Attendees will also be encouraged to share their own experiences with challenging situations.

To create a safe space for discussion, this lounge will not be recorded.

RQAP Re-registration units approved: 1 GLP | non-GCP | non-GMP

Registration available at a later date.

Upcoming Sessions in Ethics Series
Session 3 - Good Manufacturing Practices, 5 October
Session 4 - Good Pharmacovigilance Practices, 10 November
Session 5 - Artificial Intelligence, 7 December

27 August 2026, 12:00-1:00 PM EDT

SQA Webinar: The Evolving Role of Sponsors in GLP Studies: Oversight and Regulatory Expectations

Presented by:  Anand Pandya, Microcrispr Pvt. Ltd.

Webinar Category:  Compliance

Regulatory Area of Interest:  GLP

Description:
Sponsors play a vital role in ensuring that Good Laboratory Practice (GLP) studies are conducted with scientific integrity, regulatory compliance, and data reliability. While sponsors are responsible for selecting qualified test facilities, approving study protocols, and providing adequately characterized test items, they must also ensure that their involvement does not influence study outcomes or compromise independent scientific judgment. Regulatory authorities and OECD guidance emphasize the importance of transparency, proper documentation, and maintaining the independence of the Study Director and Quality Assurance Unit throughout the study lifecycle.

This presentation discusses the key roles and responsibilities of sponsors in GLP studies, including oversight of outsourced activities, communication practices, protocol management, and data integrity expectations. It further highlights regulatory concerns related to inappropriate sponsor influence and outlines practical measures to ensure unbiased study conduct, credible reporting, and regulatory acceptability. The session aims to strengthen awareness of ethical and compliant sponsor involvement within modern GLP environments.

RQAP Re-registration units approved: 1 GLP |non-GCP | non-GMP

More information and registration available at a later date.

5 October 2026, 12:00 - 1:00 PM EDT

SQA Connect Lounge Series: Ethics and/or/versus Compliance Session 3 - Good Manufacturing Practices

Presented by: Ed Armstrong, Vedanta Biosciences

Moderated by: Melanie Willis, Consultant

Webinar Category: Compliance

Regulatory Area of Interest: GMP

Registration available at a later date.

Upcoming Sessions in Ethics Series
Session 4 - Good Pharmacovigilance Practices, 10 November
Session 5 - Artificial Intelligence, 7 December

21 October 2026, 12:00-1:30 PM EDT

SQA Connect Lounge: Building Trust in Digital Documentation: Validation and Adoption of Electronic Lab Notebooks

Presented by:  Mallory Dishman, Charles River Laboratories; Ricardo Torres-Rivera, Xevalics Consulting; Jess Standerford, Celerion; Amy Sherwood, Celerion

Webinar Category:  Compliance

Regulatory Area of Interest:  GCP, GLP, IT Compliance/CSV/CSA

Description:
As laboratories shift from paper-based processes to digital environments, Electronic Laboratory Notebooks (ELNs) play a critical role in supporting data integrity, efficiency, and regulatory compliance. However, completing computer system validation (CSV) alone does not ensure a system is audit ready.

This panel discussion brings together subject matter experts in ELN validation and implementation to explore what it truly takes to deploy and sustain compliant electronic systems.

The session will begin with a concise overview of key validation principles, including risk-based approaches, system configuration, and documentation expectations. Panelists will also highlight often-overlooked considerations, particularly the needs of end users and Quality Assurance (QA) reviewers.

A key focus will be on designing ELN systems that enable efficient, consistent QA review of electronic records. Attendees will gain practical insight into how system design and workflows impact reviewability and inspection readiness.

RQAP Re-registration units approved:  1.5 GCP | GLP | GMP

More information and registration available at a later date.

29 October 2026, 12:00-1:00 PM EDT

SQA Webinar: Potential for Bias in Subject Reimbursement

Presented by:  Pam Dellea-Giltner, PDG Clinical Consulting LLC

Webinar Category:  Compliance

Regulatory Area of Interest:  GCP

Description:
What is the difference between coercion and undue influence in subject recruitment to participate in clinical research studies? How do auditors deal with potential bias being verified at Investigator Site Audits?

A recent FDA Warning letter shed light on what the FDA may be thinking and how auditors can include this in their review of investigator sites. Time for discussion and auditor experience will be included.

RQAP Re-registration units approved:  TBD

More information and registration available at a later date.

10 November 2026, 12:00 - 1:00 PM EDT

SQA Connect Lounge Series: Ethics and/or/versus Compliance Session 4 - Good Pharmacovigilance Practices

Presented by: Vaska Tone, LaVaPharm

Moderated by: Ed Armstrong, Vedanta Biosciences

Webinar Category: Compliance

Regulatory Area of Interest: GVP

Registration available at a later date.

Upcoming Session in Ethics Series
Session 5 - Artificial Intelligence, 7 December

7 December 2026, 12:00 - 1:00 PM EDT

SQA Connect Lounge Series: Ethics and/or/versus Compliance Session 5 - Artificial Intelligence

Presented by: Ricardo Torres-Rivera, Xevalics Consulting; Ashley Moore, Smithers Pharmaceutical Development Services

Moderated by: Judy Zahora, Tyra Biosciences

Webinar Category: Compliance

Regulatory Area of Interest: GLP

Registration available at a later date.

Webinar Library

Browse Webinar Recordings

Already purchased a webinar recording? Sign in and access it by going to My Account > My Online Courses & Recordings.