By Daniel Fishman, 

Senior Quality Assurance Consultant

 

Those of us in the competitive and highly regulated pharmaceutical, biotechnology and medical device industries understand the need to balance operational efficiency with regulatory compliance.  We must find ways to reduce complexities, eliminate redundancies and streamline operations while staying compliant with an array of regulations, guidance documents and regulatory expectations (some explicit, others less so). Making changes to our processes requires overcoming challenges arising from these often competing interests...

Daniel Fishman is a Senior Consultant at Complya Consulting. He has over 23 years of industry experience and global regulatory compliance/quality systems consulting that spans the broad range of the medical device, pharmaceutical and biotechnology industries. Daniel has served in internal leadership positions as a change agent with a proven track record of developing operationally efficient, compliant and implementable solutions, which he tailors to meet the needs of clients ranging from startups to multinational firms. He received his BA in biochemistry from Brandeis University. Daniel can be reached at [email protected] .  

Enith Morillo is a versatile & multilingual Quality Assurance professional with 9+ years of experience in the FDA and DEA regulated pharmaceutical space. Her specialty revolves around cGMPs and supplier quality. She is highly competent in hosting and performing quality audits, driving remediation activities when needed, and supporting drug product filings and commercialization. The majority of her experience is in small molecule, solid dosage manufacturing (tablets, capsules), with additional experience in biopharmaceuticals.

 

Enith is keen on serving her internal and external clients, and on building quality relations across an organization. She excels at rolling up her sleeves and facing a challenge head on. Enith has a M.S. in Biomedical Engineering from WPI, is an active contributor to WEST and NE PDA, and enjoys mentoring emerging professionals.

When she is not writing, Enith volunteers for non-profit boards, explores the outdoors, and travels the world with her children.