Bio Practice

A recorded webinar session discussing how to prepare for FDA inspections, what to do during the inspection and close-out interview, and how to respond to the inspection. It covers the limits of FDA's inspection scope, personnel training, SOP development, and FDA guidance documents.

A recorded seminar providing an in-depth understanding of FDA inspections, warning letters, CAPA requirements, and enforcement actions, including strategies to manage inspections and respond to FDA 483s and warning letters.

A 60-minute webinar presented by Jeff Kasoff, RAC, CQM/OE, Quality and Regulatory Affairs Consultant, including a copy of presentation slides.

A 60-minute webinar presented by Sheila J. Ramerman, RAC, Founder of SJR Associates, covering FDA Unique Device Identifier (UDI) requirements for medical devices with presentation slides provided.

A webinar on FDA medical device regulation focusing on design controls, details not fully provided.

World class in house training for startups to top companies dealing with FDA, EMA and other regulated industries, offering professional continuing education programs.

Training on analytical method validation, supplier auditing and qualification, biosimilars regulatory challenges, CMC compliance, FDA regulatory compliance, document management, European regulatory procedures, GMPs, GCP, GLP, and cGMP.

Training services provided by BioPractice in regulatory and compliance areas for medical device and pharmaceutical industries.

Training modules focused on FDA regulations and compliance for life science industry professionals.

Training on biosimilar regulatory pathways including understanding roles of national regulators and EMA, EU and FDA approval pathways, dossier contents, comparability issues, and clinical bioequivalence.

A 60-minute webinar presented by Jeff Kasoff, RAC, CQM/OE, Quality and Regulatory Affairs Consultant, covering equipment validation, tracking, calibration, and preventive maintenance with presentation slides provided.

Provides assistance in preparation and review of device submissions including 510(k)s, IDEs, PreIDEs, PMAs, HDEs, 513gs, and RFDs. Also assists with FDA Advisory Panel meetings and offers experience in device and combination product development, quality systems documentation, GxP training, and CAPA program development.

This recorded webinar helps attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. It covers how to avoid pitfalls during FDA inspections and eliminate 483 observations.

A 60-minute webinar presented by Jeff Kasoff, RAC, CQM/OE, Quality and Regulatory Affairs Consultant, covering CAPA program elements.

Training on clinical development plans, clinical regulatory submissions, clinical protocols, regulatory meetings preparation, and GCP/GLP training and audits at clinical sites by former FDA field investigators.

A recorded webinar discussing the FDA draft Guidance for Industry on proving interchangeability between an approved reference biologic product and a proposed biosimilar product.

A 60-minute webinar presented by Dr. Hoss A Dowlat focusing on the registration pathway for biosimilars in the USA to achieve swift product approvals. Presentation slides are shared.

A 60-minute webinar presented by Dr. Hoss A Dowlat providing executive insights into the FDA Purple Book classification and other FDA initiatives related to biologics and biosimilars, including background on the first two 351k ABLA submissions to FDA in 2014. Presentation slides are shared.

A recorded webinar presented by Dr. Hoss A Dowlat, VP, Global Strategy at PharmaBio Consulting, covering FDA's position on biosimilar interchangeability and the FDA's 2015-established "Purple Book" rating system.

Training focused on Corrective and Preventive Actions (CAPA) and critical documentation management for clinical trial activities, especially during and after COVID-19 restrictions.

A webinar program conducted by Dr. Hoss A Dowlat, RA, focusing on regulatory submissions for medical devices including 510(k)s, IDEs, De Novos, PMAs, and Q-Submissions.

A webinar conducted by Brian G. Nadel covering FDA Warning Letters, FDA Form 483 observations, and import alerts relevant to pharmaceutical companies.

A 60-minute webinar presented by J. Lawrence Stevens, RAC, FDA Regulatory Expert, Consultant, including a copy of presentation slides.

A recorded webinar providing a high level understanding of the factors that influence the uptake of biosimilars in the market.

A recorded webinar providing essential scientific, regulatory and business perspectives on biologics and biosimilars, focusing on EMA vs FDA comparability, approval strategy, and market penetration. Includes 60 minutes of presentation plus 10-15 minutes Q&A, with presentation slides shared and unlimited playback.

A 60-minute webinar presented by Dr. Afsaneh Motamed Khorasani, PhD, Vice President, Medical Affairs, Easy Global Training. Includes a copy of presentation slides.

A 60-minute webinar presented by Danielle DeLucy, MS, Assoc Director of QA and Microbiology, Musculoskeletal Transplant. Includes a copy of presentation slides.

A webinar conducted by Dr. Hoss A Dowlat, RA, targeting Indian pharmaceutical companies to support regulatory submissions in EU and US markets.

A 60-minute webinar presented by Ranjt Barshikar, Quality Management Consultant, QbD International, on QMS compliance key elements.

A 60-minute webinar presented by J. Lawrence Stevens, RAC, FDA Regulatory Expert, covering FDA requirements for medical devices and practical solutions to FDA compliance issues with presentation slides provided.

A 60-minute webinar presented by Sheila J. Ramerman, RAC, Founder of SJR Associates, explaining the FDA 510(k) submission process for medical devices with presentation slides provided.

A 60-minute webinar presented by Danielle DeLucy, MS, Assoc Director of QA and Microbiology, Musculoskeletal Transplant, including a copy of presentation slides.

A recorded webinar presentation addressing the challenges in developing biosimilar orphan drugs, discussing regulatory perspectives from FDA and EMA, and encouraging debate on this emerging topic.

A seminar reviewing QSR and ISO requirements for supplier evaluation and assessment, providing cost-efficient, compliant options for supplier qualification, nonconformance handling, and corrective action requests.

A 60-minute webinar presented by Danielle DeLucy, MS, Assoc Director of QA and Microbiology, Musculoskeletal Transplant, on FDA expectations for supplier management.

A 60-minute webinar presented by Sheila J. Ramerman, RAC, Founder of SJR Associates, covering FDA PMA submission details.

A 60-minute webinar presented by Brian G. Nadel, President of Brian G. Nadel GMP Consulting LLC, focusing on FDA CGMP and data integrity.

A 60-minute webinar on FDA QSIT and its application for advantage in quality systems inspection.

A recorded full-day seminar designed for biotechnology, pharmaceutical, and medical device business executives and others interested in regulatory requirements for launching new products, comparative effectiveness, real world data, and biosimilars.

A 60-minute webinar presented by Dr. Hoss A Dowlat, RA, VP, Global Strategy, PharmaBio Consulting, covering orphan medicine development and approval.

A 60-minute webinar presented by Vishnu Patil, Pharmaceutical Quality Advisor. Includes a copy of presentation slides.

A 60-minute webinar presented by Edwin Waldbusser covering compliance with 21 CFR Part 11 for medical devices with presentation slides provided.

A 60-minute webinar presented by Lori B. Pereira, Founder & Principal, Spectra Health Solutions. Includes a copy of presentation slides.

A 60-minute webinar presented by Sheila J. Ramerman, RAC, Founder of SJR Associates, focusing on FDA labeling requirements for medical devices with presentation slides provided.

A recorded seminar workshop providing knowledge on new FDA requirements for Risk Evaluation and Management Strategies (REMS) and tools to design and execute post-marketing surveillance studies.

A 60-minute webinar presented by Amy Peterson, Owner, Effective Quality Systems. Includes a copy of presentation slides.

A 60-minute webinar presented by Samuel Santiago, PhD, MBA, Executive Director, Global Biotech Strategies, covering FDA guidelines for IoT wireless medical devices with presentation slides provided.

A 60-minute webinar presented by Dr. Afsaneh Motamed Khorasani, PhD, Vice President, Medical Affairs, Easy Global Training. Includes a copy of presentation slides.

A 60-minute webinar presented by BioPractice, including a copy of presentation slides.

Guidelines training for office and outpatient visits in the healthcare setting, reflecting 2021 standards.

A fellowship program focused on 2D Echocardiography, providing specialized training in this clinical imaging technique.