Let's Combinate - Pharma + Medical Devices with Subhi Saadeh15 Mar 2023

076 - GMP Training, Competence, Human Error and Mentorship with Joanna Gallant

On this episode, I was joined by Joanna Gallant of JGTA. Joanna walks through:

Training programs at companies that had consent decrees
The difference between good training and bad GMP training
Competence in knowledge work
Human Error

Joanna Gallant is an experienced, solutions-driven Quality and training professional who has spent more than 30 years in pharmaceutical, biotechnology, tissue culture and medical device development and manufacturing environments. Over her career, she has provided regulatory, technical, skill, and management development training support to all operations functions, as well as IT, R&D, Customer Service and senior management. Now, as a training system consultant, she works with clients to design and deliver custom training and build/remediate training systems, including in support of regulatory audit observations and commitments. Joanna has been a GMP TEA member since 2001, and now serves on the Board of Directors as an Advisor. She is one of the founders of the Biomanufacturing Certificate Program at Worcester Polytechnic Institute, and became an Adjunct Professor at the Boston University School of Medicine’s Biotechnology degree program in 2011. Joanna writes a popular article series for Pharmaceutical Online on the people side of pharma & GMP, provides monthly interactive web courses through LifeScience Training Institute, and through her JGTA, LLC business, authored GMP Training Can Be Fun! along with an ever-expanding line of GMP training games and activities.

Denne episoden er hentet fra en åpen RSS-feed og er ikke publisert av Podme. Den kan derfor inneholde annonser.

Episoder(266)

258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin

Combination product quality with Ben Locwin: why drug and device quality systems differ, how human factors studies are designed, what to do when a CDMO's clean audit doesn't match its performance, and...

12 Okt 34min

257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products

21 CFR Part 4 sets the CGMP requirements for combination products. If your product has a drug and a device in it, you're on the hook for both sets of regulations. In this video, I walk through Part 4 ...

5 Okt 12min

256 - The New FDA Inspection Playbook: Where to Start with QMSR

QMSR became effective on February 2, 2026. Alongside that change, FDA retired the Quality System Inspection Technique (QSIT) and began using the inspection process described in Compliance Program 7382...

28 Sep 9min

255 - Audit Interview Techniques: How Good Auditors Get Better Evidence

A huge part of the job is knowing how to interview people, understand how work is actually performed, and corroborate what you hear against records, observations, and other objective evidence.In this ...

21 Sep 11min

254 - Saying No Is the Easy Part of Quality

Quality has a reputation for saying no.Sometimes that’s exactly the right call. Other times, “no” is just the easiest answer.In this episode, Subhi breaks down four situations where Quality should abs...

13 Sep 12min

253 - FDA Is Making Big Changes to Its Inspection Approach

FDA is changing how it organizes and deploys its investigators but it isn’t simply returning to the old generalist model.Eric Pittman spent more than 20 years at FDA, conducted approximately 800+ insp...

7 Sep 45min

252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)

Acceptance sampling is one of the most commonly used and commonly misunderstood tools in quality.In this video, I break down the fundamentals of acceptance sampling: what it is, what an AQL actually m...

31 Aug 13min

251 - The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy

In this episode, Subhi Saadeh sits down with Steven Kaufman, Founder of Combination Product Solutions, Inc. and fractional Chief Commercial Officer at Portal Instruments, to discuss where the drug del...

24 Aug 49min