https://www.spreaker.com/podcast/cmc-live-chemistry-manufacturing-controls--4663943enChemistryCopyright Tom Zeebhttps://d3wo5wojvuv7l.cloudfront.net/t_rss_itunes_square_1400/images.spreaker.com/original/ac44f4c883939b29257bc49b5ae2545b.jpghttps://www.spreaker.com/podcast/cmc-live-chemistry-manufacturing-controls--4663943Sun, 05 Sep 2021 07:50:36 +0000Tom ZeebTom Zeebfeeds@spreaker.comFDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and...false26de9668-f724-5d06-ac11-d065b4f906f4episodichttps://www.spreaker.com/episode/024-quality-management-systems-explained--4380461101410dcf-a365-4111-8865-445bb164a5d0Fri, 05 Mar 2021 11:00:00 +0000Tom ZeebBettina Kaplan is the Head of Quality Assurance Services, Robbi Freisem and Susan Fasso are Senior Quality Assurance Consultants and Maria Arakil is a Quality Assurance at Design Space InPharmatics. Together, this talented panel of subject matter...2339falsefullhttps://www.spreaker.com/episode/023-a-broadway-performance-analogy-for-api-process-validations-with-jim-mencel--43804613b21827d5-501f-4420-881c-5969411cc2d1Fri, 26 Feb 2021 11:00:00 +0000Tom ZeebJim Mencel is Senior Drug Substance Consultant at Design Space InPharmatics. With an extensive background in CMC management, Jim has a wealth of knowledge on the topic of process validation. Process validation is an integrated and mandatory process in...2634falsefullhttps://www.spreaker.com/episode/022-filter-validation-how-it-impacts-getting-your-product-to-market-with-shelli-connelly--4357826343522446-c0d6-42dd-ac29-3379709c14a9Fri, 19 Feb 2021 11:00:00 +0000Tom ZeebShelli Connelly is a Senior Drug Product Consultant at Design Space InPharmatics. With over 20 years of long- term success in the pharmaceutical manufacturing industry, Shelli has expertise in pharmaceutical process validation, business development...1931falsefullhttps://www.spreaker.com/episode/021-regulatory-odd-couple-with-ed-narke-meranda-parascandola--435782660847ff60-8c2e-4cf3-a577-380b89df05dbFri, 12 Feb 2021 23:00:00 +0000Tom ZeebEdward Narke is a Principal and Regulatory Managing Director and Meranda Parascandola is the Head of Business Development & Marketing at Design Space InPharmatics. Today, Ed and Meranda discuss topics they’ve covered on DSI’s ongoing blog series, The...3618falsefullhttps://www.spreaker.com/episode/020-lessons-gleaned-from-twenty-five-years-of-a-regulatory-cmc-life-with-ed-narke--433298454a0f2c55-1048-43be-bb8a-4da7af60a1b7Fri, 29 Jan 2021 11:17:59 +0000Tom ZeebEd Narke is the co-founder, Principal and Managing Regulatory Director at Design Space InPharmatics. In this episode, Meranda and Brian are turning the tables on Ed and turning him from interviewer to interviewee. Ed touches on his hometown roots, his...2893falsefullhttps://www.spreaker.com/episode/019-complexity-of-project-management-in-drug-development-with-paul-long--430766094d455d20-1efa-4bfa-a57d-234d60e19726Fri, 22 Jan 2021 11:48:30 +0000Tom ZeebPaul Long is a Project Management Consultant at Design Space InPharmatics. Paul has supervised government regulatory pharmaceutical industries for over twenty years and has a wealth of business knowledge. He knows how to build and lead...2597falsefull