March 28, 2017
Quality Risk Management and Microbiology Consultant Amanda Bishop McFarland is the new co-leader of the Parenteral Drug Association (“PDA”) Quality Risk Management (“QRM”) Interest Group. The QRM Interest Group provides PDA members a forum to learn, promote, and share best practices that incorporate and advance QRM methods in their respective organizations. McFarland is responsible for providing focus, structure, consistency and direction to PDA QRM activities, conferences, courses and publications.
March 7, 2017
ValSource Senior Consultant Marsha Hardiman is a featured speaker at the Parenteral Drug Association (“PDA”) Southern California Chapter Aseptic Processing and Contamination Control Symposium. The
symposium takes place Thursday, March 14th at Crown Plaza Costa Mesa in Costa Mesa, CA. Hardiman presents the session: “Creating Your Monitoring Plan and Risk Assessment for ISO 14644-1 and 14644-2.” Marsha’s presentation addresses the changes to ISO 14644 Parts 1 and 2 and focuses on the factors to consider when performing risk assessment and creating a monitoring plan….
November 15, 2016
Lorianne (“Lori”) Richter has joined ValSource as a Senior Consultant. Lori brings 17 years of experience and expertise in biotechnology manufacturing processes, quality systems, and business process development.
“I am passionate about developing a pragmatic approach to Quality Risk Management,” Lori comments. “ValSource affords me the perfect opportunity to share my passion and experience on a team, one that is influencing how the industry enhances Quality Management Systems to drive continuous improvement.”
Lori holds a Microbiology degree from California State University, Chico….
October 21, 2016
Quality Risk Management and Microbiology Consultant Amanda Bishop McFarland is a featured speaker at the Parenteral Drug Association Southeast Chapter 2016 Fall Conference. The conference takes place Thursday, November 3rd at Brier Creek Country Club in Raleigh, NC. McFarland presents the session: “Implementing a Robust Quality Risk Management Program.” Her presentation addresses ways to evaluate current risk management programs and identifies elements to consider when implementing new, or enhancing existing, risk management programs.
“More than a decade after ICH Q9 Quality Risk Management was published, areas of our industry are still struggling with navigating the guidance and identifying the appropriate ways to integrate risk management into their businesses,” McFarland said. …
June 6, 2016
ValSource today announced Fred Hammonds has joined as a Senior Director. Hammonds brings more than 30 years experience in the safety field. He now leads ValSource’s Construction and Site Safety Services department. Under Hammonds’ leadership, ValSource’s Safety Solutions Group acts proactively to secure worksites, schedule field audits and train and resource qualified safety professionals at its clients’ facilities worldwide. Hammonds also leads safety training for ValSource’s more than 200 employees.
ValSource Founder David Calvaresi commented, “ValSource has always been committed to safety….
October 16, 2015
ValSource announced, Senior Consultant Christopher M. Hanff has been named an ASQ-Certified Manager of Quality/Organizational Excellence (“ASQ CMQ/OE”). This achievement demonstrates Mr. Hanff’s receipt of significant professional recognition, indicating proficiency in and comprehension of quality management principles and practices. The ASQ CMQ/OE is a professional who leads and champions process-improvement initiatives and must have 10 years of work experience related to the body of knowledge.
Mr. Hanff has over 16 years of experience in biopharmaceutical operations and quality systems….
October 2, 2015
ValSource announced, Senior Microbiology and Regulatory Consultant David (”Dave”) Hussong, Ph.D. has been recognized by the Parenteral Drug Administration (“PDA”) for his contribution to the evolution of the Annual Global Conference on Pharmaceutical Microbiology. As it celebrates 10 years of networking, sharing and learning from experts and professionals in pharmaceutical manufacturing, PDA recognizes Dave’s work for the significant role he has played in helping make these annual conferences so successful.
A formal presentation of the award will take place at the PDA 10th Annual Global Conference on Pharmaceutical Microbiology Gala Dinner on Tuesday, October 20th at 6:00 p.m….
June 17, 2015
ValSource announced, Amanda Bishop McFarland has joined North America’s largest independent validation services company as a consultant. Prior to ValSource, Amanda spent five years with Genzyme, most recently serving as Senior Continuous Process Improvement Analyst.
Amanda McFarland comments, “ValSource provides me the perfect opportunity to share my QRM and Microbiology knowledge to influence change in our industry.” Amanda specializes in quality risk management, program implementation and partnership development and contamination control.
Amanda McFarland earned both her Bachelor of Science in Entomology and her Master of Science in Mycology and Air Quality from the University of Florida….
April 21, 2015
ValSource announced Jeffrey L. Hartman has joined North America’s largest independent validation services company as a Senior Validation and Quality Risk Management (“QRM”) Consultant. Prior to ValSource, Jeff Hartman spent 34 years with Merck, most recently serving as Director of Validation Quality Systems for Merck Manufacturing Division.
Considering his future with ValSource, Hartman commented, “Candidly, I’m past the point of having to work. I’m relishing working with such a great company. ValSource’s vision of returning validation to a vital, valuable tool for companies aligns perfectly with my own professional philosophy.” He continued, “I’m energized and look forward to the knowledge transfer process with ValSource’s clients….
March 9, 2015
ValSource announced David Hussong, Ph.D. has joined the company as Senior Microbiology and Regulatory Consultant. David Hussong has spent most of his entire career, more than 30 years, at the Food and Drug Administration. For the last decade he served as Supervisor of the New Drug Microbiology Staff in the Office of Pharmaceutical Science (“OPS”) and as the Associate Director for New Drug Microbiology, OPS – Center for Drug Evaluation and Research (“CDER”). There, his work encompassed significant policy and scientific influence in all matters of review of microbiology issues and products applications….