Training Doyens

OVERVIEW The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised. Most important are the direct benefits to our primary customer; the patient. Per Janet Woodcock M.D. Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration “All products are designed and developed to be of high quality; Quality by Design provides a structured framework for developing, documenting and presenting development rationale, experience and knowledge of the formulation and the process, and to ensure manufacture of products consistently fit for patient use.” Application of these principles can also benefit the pharmaceutical companies by improving manufacturing efficiency and promoting innovation. WHY SHOULD YOU ATTEND However, implementing these principles into the pharmaceutical development culture can be challenging. QbD involves a complex set of interactions, technologies and systems that are not easy to grasp. This qual...

Cyber Security Risk Assessment

Peter Goldmann Peter Goldmann President of FraudAware LLC Years of Experience:  25+ years Areas of Expertise:  Risk Assessment, and Fraud Prevention and Investigation Peter Goldmann  is President of FraudAware LLC,the publisher of White-Collar Crime Fighter, a widely read bi-monthly newsletter for internal auditors, controllers, corporate counsel, financial operations managers and investigators. The newsletter is in its 15th year of publication under Peter’s leadership. Peter is the author of Fraud in the Markets: Why it Happens and How to Fight It, published by John Wiley &Sons. The book is an in-depth account of the role that fraud played in bringing about the financial crisis of 2008.  Peter is also the author of four other anti-fraud books covering accounts payable fraud, accounts receivable fraud, as well as two workbooks on fraud and cyber-risk and control, also published by Wiley. Peter also developed FraudAware, the leading fraud and c...

Paul J. Sanchez Paul J. Sanchez President, Professional Service Associates (PSA) Years of Experience:  30+ Areas of Expertise:  Accounting, Auditing, Banking, and Risk Assessment Paul J. Sanchez , CPA, CBA, CFSA, CGMA conducts a small CPA practice in Port Washington, New York. He is also the owner of Professional Service Associates (PSA), a consulting and professional training and development business servicing corporate clients (auditors, controllers, etc.), CPA firms, professional associations and others. He was an assistant professor at Long Island University - C.W. Post Campus as well as an adjunct lecturer at City University of New York. Prior to starting PSA, he was the Vice President-Professional Development for the Audit Division of a regional bank and Director of Professional Practices and Vice President of a money-center bank, where he directed the professional practice development and training for internal auditors. He also was on the technical staff...

Kalpeshkumar R. Vaghela Kalpeshkumar R. Vaghela CEO, Infra Control Systems Years of Experience:  30+ years Areas of Expertise:  CSV and Data Integrity Audit Mr. Kalpeshkumar R. Vaghela  is the CEO of Infra Control Systems. He has 30 years of experience as    Software Validation Specialist, Expert Trainer CSV-    Data Integrity- GAMP5- 21 CFR part 11 Compliance- ICH Q9, Risk assessment- Proactive CSV Approach .    Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve compliance by training and motivating professionals for QbD and Right First Time Approach. He has supported client for many USFDA, MHA, ANVISA, MCC, and TGA Customer Audits as a CSV consultant. About 11 years of work experience on high level CSV Validation in India and Abroad has made Mr. Vaghela a subject matter expert in CSV, Data Integrity Audit for Life Science- Medical Device and Clinical Research Industry. H...

OSHA Inspection