ISPE

JUNE 27, 2023

This group is also connected with US regulators e.g., Biomedical Advanced Research and Development Authority (BARDA), UK colleagues in MHRA, and Pharmaceutical Inspection Co-operation Scheme (PIC/s) as well as other agencies. It was moderated by Mark Birse, Vice President Technical, Strategic Compliance Consulting, Parexel.

Communication 52

Communication FDA Vaccines 52

ISPE

SEPTEMBER 8, 2023

At this year’s session, most questions focused on technical pharmaceutical queries related to sterile products, whereas last year’s panel had a lot of questions around audit practices during the pandemic and learnings from virtual and hybrid inspections. Attendees were invited to submit questions to the FDA representatives.

FDA 52

FDA Vaccines Documentation 52

ISPE

APRIL 12, 2023

A Closer Look at Paperless Validation’s Impact on Biotech Trudy Patterson Wed, 04/12/2023 - 07:34 iSpeak Blog iSpeak A Closer Look at Paperless Validation’s Impact on Biotech Steven Thompson 12 April 2023 The impact of paperless validation on the biotechnology industry is massive, and the overall effect is growing as adoption increases.

Documentation 98

Documentation FDA 98

ISPE

FEBRUARY 14, 2023

This blogpost will summarize inspection topics for presenting digital CQV content and provide a list of common questions encountered during inspection events. During paper-based inspection events, a CQV package is requested and a printed report with a physical binder are brought in to support the request.

Documentation 52

Documentation Packaging 52

ISPE

NOVEMBER 2, 2022

The gavel passed to a new International Board Chair and ISPE leaders shared 2022 achievements and plans for 2023 at the 2022 ISPE Membership Meeting and Awards Lunch. Rutherford. Executive Director, Computer Systems Quality & Data Integrity. Syneos Health. The Year in Review. Jörg Zimmermann. One ISPE initiative is a work in progress, he said.

Documentation 52

Documentation Compounding Communication FDA 52

ISPE

JUNE 21, 2023

The ISPE Sub-Committee for Paperless Validation has defined ‘Paperless Validation Systems’ as Paperless solutions enable validation lifecycle deliverables to be generated, approved, and more importantly, testing to be completed without the need for the printing of paper test documents. Is there a gap in features from the vendor/technology side?

Documentation 52

Documentation Data Entry Compounding FDA 52

European Pharmaceutical Review

JANUARY 16, 2023

Another major topic covered by the experts was technological advances. Changes may be needed, such as improved corporate culture, information management, retraining of personnel, and upgraded facilities, suggested Cundell. He questioned how regulators will enforce revisions to Good Manufacturing Practice (GMP) regulations.

Vaccines 126

Vaccines FDA Research Laboratories Documentation 126