iSpeak Blog
  As Co-Chairs of the 2017 ISPE Process Validation Statistics Conference, we are pleased to invite you to join us in Bethesda, Maryland, 13 – 15 September as we explore evolving and state-of-the-art approaches to implementing statistics in process...
iSpeak Blog
    Mihaela Simianu, PhD, Director of Regulatory Compliance, Pharmatech Associates, Inc., led an interactive session on Emerging Therapeutic Entities in Immunotherapy and Gene- and Cell-Based Therapies on 6 June 2017, day 2 of the 2017 ISPE/FDA/PQRI...
iSpeak Blog
It’s time for another edition of Reading Roundup featuring the top blog posts of June 2017. Start off your week by catching up on what the pharmaceutical industry was reading in June. Extractables and Leachables: Not the Same – Part 2 As a follow-up to...
iSpeak Blog
Interactive Discussion on Drug Shortages Prevention François Sallans, Vice President, Quality and Compliance, Chief Quality Officer, Johnson & Johnson, and Chair of the ISPE Drug Shortages Initiative, led the featured session “Interactive Discussion on...
iSpeak Blog
Participants gathered for the Women in Pharma (WIP) breakfast on day 2 of the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference, held 5-7 June 2017.  Women in Pharma Chair Fran Zipp, President and CEO, Lachman Consultants and ISPE Board member,...
iSpeak Blog
Proactive Approaches to Facility and Life Cycle Quality Management Workshop Jim McGlade, Science Client Leader for BHDP Architecture, led the “Proactive Approaches to Facility and Lifecycle Quality Management” Workshop. “What’s an architect doing in...
iSpeak Blog
It’s time for another edition of Reading Roundup featuring the top blog posts of May 2017. Start off your week by catching up on what the pharmaceutical industry was reading in May. Celebrate 8 Companies Who Are Advancing Pharmaceutical...
iSpeak Blog
Clinically Relevant Specifications (CRS) are a set of criteria and acceptance ranges—such as impurities, dissolution, and in vitro release testing—to which drug products should conform to deliver their therapeutic benefits. Questions remain on...
iSpeak Blog
Round Table Provided Open Conversation with FDA Regulators Disclaimer: This is an abridged, unofficial summary of an FDA panel Q&A that has not been vetted by the agency. The responses below are an informal synopsis of the regulators’ views. These...
iSpeak Blog
Over 90 industry professionals recently participated in ISPE’s inaugural 2017 Pharmaceutical Serialization Workshop held at the Sonesta Hotel in Philadelphia, Pennsylvania, USA. With the deadline quickly approaching in the USA and eminent in Europe,...
iSpeak Blog
Japan Affiliate Celebrates 15 Years! On 17 – 20 May, the Japan Affiliate held their Annual Meeting at the Toyoma International Conference Center, Toyama, Japan and celebrated their 15-year anniversary.  The meeting theme was “A Brave New World of...