1000+ Sessions conducted on USFDA,EMA and APAC

Friday, 31st July, 2026 1:00 PM EST 11:00 AM PST

To attend this webinar kindly call 1-646-216-8860 or email at marketing@biopractice.com FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. However, there are ways to validate equipment already in use! This webinar will discuss Equipment Calibration Requirements, Preventive Maintenance Requirements, when to use Calibration when to use Maintenance, what is Remedial Action for Out-of-Calibration Equipment, how to use of Calibration Standards to Save Cost. Areas Covered in the Webinar: Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification.. Equipment Preventive Maintenance Requirements. Calibration vs. Maintenance: When to use Which One? Remedial Action for Out-of-Calibration Equipment. Use of Calibration Standards to Save Cost. Equipment Calibration Requirements: Scheduling, Use of External Services, and Documentation.

Jeff Kasoff, RAC, CQM/OE, has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS in 1996, his Manager of Quality and Organizational Excellence certification from ASQ in 2013, and his Lean Black Belt from IIE in 2014.

Friday, 14th August, 2026 1:00 PM 11:00

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits. Areas Covered in the Session: How to prepare for an FDA inspection Development and contents of an SOP for FDA inspection Personnel training before inspection How to behave during an inspection Limitations of scope of inspection Response to investigation findings FDA guidance documents used by their inspectors

Jeff Kasoff, RAC, CQM/OE, has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS in 1996, his Manager of Quality and Organizational Excellence certification from ASQ in 2013, and his Lean Black Belt from IIE in 2014.

Monday, 24th August, 2026 1:00 11:00

FDA in the recent past has become much more enforcement minded. The number of Warning Letters issued so far in 2014 are on pace to increase by almost 50% over the number 2013 Warning Letter. Your firm needs to be prepared and implement controls based upon what FDA currently expects. Past compliance may no longer work. FDA has raised the bar. We will discuss those areas of your firms operations that are most likely to show problems that will show up on FDA-483’s and Warning letters, and how to avoid being the subject of FDA regulatory actions. We will talk about how to implement actions to avoid FDA problems. We will also discuss how to talk to FDA to avoid FDA regulatory actions. Your instructor has been both an FDA employee and an employee in private industry. In addition he has been a high level FDA manager, and a senior executive in private industry, thus he has truly lived in two different worlds, and can speak from personal experience. Key goals of the Webinar will include: Understand what is going on in FDA that has them more enforcement oriented. Become familiar the types of medical device issues on which FDA concentrates Identify preventive actions that can be taken to avoid FDA issues Know how to respond to an FDA-483 to avoid a Warning Letters Know what to expect if a follow-up inspection results in an FDA-483 Know how to meet with FDA and what to not say or do Know how to negotiate with an FDA manager to resolve issues. Know how to train your own employees in methods of dealing with FDA

Mr. J Lawrence Stevens has over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also Mr. Larry has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. Mr. J Lawrence has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public.

Monday, 31st August, 2026 1:00 PM 10:00 AM

The regulation and control of new or substantially changed medical devices for sale in the US is based on the 510(k), PMA or DeNovo submission process; 510(k)s now can only be submitted to the FDA under the eSTAR (electronic Submission Template And Resource) Portal. Other submissions will be phased in using new guidance templates as they become available.

Specialties: REGULATORY AFFAIRS EU/USA, MAA/NDA/BLA/ABLA, BIOLOGICS, BIOSIMILARS, ORPHANS, Scientific Advice. Pharmaceutical and clinical development CTAs/INDs. Due deligence in/out licencing.

Hoss leads an international team of drug development Principal Consultants at his self-owned PHARMABIO CONSULTING. His experience encompasses strategic regulatory support and Due Diligence to 70 Pharma client companies from across Europe, America, Canada, China, Korea, Taiwan, Japan, and India and to the financial sector New York US and London UK.

Hoss was until 2010 Vice-President, Technical, Drug Development and Regulatory Global Strategy Services, at the leading CRO PAREXEL International. In PAREXEL CONSULTING 2000-2010 he provided a direct consulting service to more than 50 Pharma client companies Prior to this he was leading drug development programs and registrations in several international Pharma companies.

Hoss is British-Canadian educated in England to B.Sc. and PhD level, and was also a recipient of a Post-doctoral European Royal Society Fellowship award in organic chemistry. He has more than 31 years of drug development experience in over 15 therapeutic areas in the European and North American pharmaceutical industry, 21 years of which have been in regulatory affairs.

His strength is in therapeutic proteins such as novel and biosimilar monoclonal antibodies. He has substantial Orphan Drugs development experience additionally, and is applying it to niche area of orphan biosimilars. Has unique insights into the FDA-EMA requirements.

Extensive experience preparing clients for FDA meetings and has led, managed and attended across FDA meetings, in particular, formal Type B, NDA/BLA and BsUFA ABLA presubmission meetings. Highly experienced with EU: MAA presubmission EMA meetings, MAA presubmission Rapporteur/Co-rapporteur, D120 and D180 Clarification meetings SAWP/CHMP/EMA Scientific Advice.

Pioneer in European biosimilar approvals as regulatory lead to one of 2 EU Biosimilar MA hGH approvals in April 2006.

Hoss has published 5 milestone articles on biosimilars in 2012; March (US), April (EU), May (EU), May (US) and July (US), and a RAPS book biosimilars chapter in 2013, and broadcasts to US and EU monthly thought leadership professional webinars 2011-present. The latest international article in progress 2015 is on “Interchangeability among reference insulins and their biosimilars: regulatory framework, study design, and clinical implications”.

He is also a well-established international trainer (to Pharma and Agencies) and conference and webinar presenter in EU/US regulatory affairs, biologics/biosimilars, scientific advice, the Common Technical Dossier (MAA/NDA/BLA), labeling (prescriber and patient), clinical safety, pharmaceutical development, and combination drugs.