Cobblestone » Subjects

Writing and Enforcing SOPs: Best Practices for Regulated Industries

“Writing and enforcing effective standard operating procedures (SOPs) can be challenging. Poorly written SOPs are one of the most common causes of deficiencies and observations cited in 483s and warning letters from the FDA. Companies in regulated industries must know how to organize and deliver information for the intended audience and the intended purpose. This… Continue reading Writing and Enforcing SOPs: Best Practices for Regulated Industries

Qualification and Management of CMOs (Contract Manufacturing Organizations)

Every pharmaceutical company hopes to obtain their desired expectations when it comes to important relationships with their Outsourcing Partners. This intensive course examines the root causes of critical issues that can arise within these relationships which are much broader and deeper than the technical capability to perform a process. This intensive 12-hour, accredited course, examines… Continue reading Qualification and Management of CMOs (Contract Manufacturing Organizations)

Beatrice Huey

Ms. Beatrice Huey is currently employed as a Good Tissue Practice Specialist at the University of Arkansas for Medical Sciences in Little Rock, Arkansas. She has more than 20 years experience working in FDA-regulated environments and the tissue industry. She has extensive knowledge of current good tissue practice (CGTP), good manufacturing practices (CGMP) and good… Continue reading Beatrice Huey

Joy Joseph

Joy Joseph is President of Joys Quality Management Systems, a consulting firm serving Dietary Supplement firms through training and implementation of the new cGMPs. She has more than 40 years experience in Quality Control Systems, Regulatory Affairs, Product Development, Manufacturing, and Scientific Affairs in the Pharmaceutical, Dietary Supplement and Cosmetic industries. Ms. Joseph received her… Continue reading Joy Joseph

Zeinab Schwen

Zeinab Schwen is an experienced technical expert, writer, lecturer, and entrepreneur with over 39 years in the pharmaceutical and medical device industries. While working for major pharmaceutical companies, Ms. Schwen gained hands-on experience in drug metabolism, drug development, and clinical trial management. She monitored large multicenter trials and participated in writing and preparing large drug… Continue reading Zeinab Schwen

Irwin Silverstein, Ph.D.

Irwin Silverstein has been a consultant to the pharmaceutical industry since 2000. His career included 17 years as the head of corporate quality for ISP, a specialty chemical manufacturer that produced excipients and Active Pharmaceutical Ingredients. Since leaving ISP, he works as a consultant. He has been a subcontractor to a consulting firm hired as… Continue reading Irwin Silverstein, Ph.D.

Edwin Waldbusser

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 12 years. Mr. Waldbusser has a BS in Mechanical Engineering and an… Continue reading Edwin Waldbusser

J. Mark Wiggins

Mark Wiggins is Owner and Compendial Consultant with Global Pharmacopoeia Solutions LLC, which he formed after more than 30 years experience in the pharmaceutical industry. He was previously Director of Compendial Affairs at Merck, with more than 15 years experience submitting new and revised monographs to pharmacopoeias, as well as reviewing and responding to proposed… Continue reading J. Mark Wiggins

Bonnie M. Pappacena

Bonnie M. Pappacena is the President, Qualture LLC, a Quality consulting firm committed to building Quality into company culture. Ms. Pappacena has been a Quality professional for over 35 years spanning the animal health, biological, chemical, device, generic, and pharmaceutical industries. She possesses hands-on experience conducting and managing audits in GCP, GLP, GMP (clinical supplies… Continue reading Bonnie M. Pappacena

Philip E. Sax

Phil Sax is an early thought leader for CSV. A Founder and President of Weinberg Spelton and Sax, a Computer System Validation Consultancy, he has been involved in hundreds of successful validation projects. He has trained more than 1000 professionals, including FDA staff, and has served as Vice President and Chief Regulatory and Quality Officer… Continue reading Philip E. Sax