Voices In Validation

This week, Stacey is joined by Raechelle Raimondo, Executive Director Global IT Systems Assurance and Compliace at Abbvie.

Raechelle has more than 20 years of experience working for large/global corporations, small businesses and start-up companies. A proven history of implementing global systems utilizing a risk based systems lifecycle (SLC) approach and managing teams to support multiple projects, including forecasting and managing budgets. Strengths include leadership, portfolio/program management, delivering results, managing multiple priorities, effecting change, building teams, problem-solving, using interpersonal skills to build effective relationships, and understanding the link between technology & business needs to deliver compliant solutions that optimize processes & efficiencies.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

In this episode, Jim and Stacey speak about the reasoning for such an emphasis on investigations and corrective actions, highlight the current guidance on CAPA investigations, cover the best tools for investigations beyond the “5 Whys” and Fishbone diagram, dispelling the “rule of three” that many companies count on, while defining what constitutes an acceptable root cause, “human error,” “training” and “revise the procedure" over used in corrective actions, and much more.

James Vesper has worked in the pharmaceutical industry for more than 35 years, starting out at Eli Lilly and Company where his last position was leading the GMP training initiative. For 24 years, he was President of Learning Plus, a training consultancy and, in 2017, he joined ValSource as Director of Learning Services. Dr. Vesper has authored numerous books, book chapters, articles, and also speaks and teaches at international conferences and workshops, as well as consults for the World Health Organization (WHO). He received his PH.D. in education from Murdoch University, Perth, Australia.

For step by step investigation advise, and tips on drilling down into the root cause for CAPA planning and analysis our listeners can revie Jim’s latest book: Root Cause Investigations for CAPA: Clear and Simple by visiting the PDA Bookstore at https://www.pda.org/bookstore/product-detail/5724-capa

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes back Alan Golden from Design Quality Consultants. Stacey and Alan have a conversation about combination products and what you need to be aware of.

• A review of the types of combo products, single-entity, co-packaged, and cross-labeled, as well as the FDA Guidance.

Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.

Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.

Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Voices in Validation, Stacey Bruzzese, IVT Network, pharmaceutical, biotech, laboratories, medical devices, patient safety, quality control, United Podcast Network, Studio 21 Podcast Café, Alan Golden, Design Quality Consultants, change control, combination products,

Stacey Bruzzese welcomes Eric Kastango to the show. Today, Stacey and Eric discuss the how FDA has implemented temporary guidelines and how companies can mitigate their risks to consumers and compounding sites.

Eric has dedicated his life’s work to patient safety through better sterile compounding, aseptic manufacturing, lean production, and robust quality management practices. has practiced pharmacy in hospital, community, and homecare settings in a variety of roles. He was previously Corporate Vice President of Pharmacy Services for Coram Healthcare and also managed a cGMP outsource manufacturing operation for Baxter Healthcare. In addition to his consulting role, Eric continues to serve as a sterile compounding, 503B outsourcing, and patient safety subject matter expert for his clients, the American Society of Health-System Pharmacists, State Boards of Pharmacy, and was one of the key US Department of Justice expert witnesses during the New England Compounding Center trials from 2017-2019.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes David Nettleton to the show. Today, Stacey and David will discuss the 6 most common problems in FDA validation and verification.

David is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA compliant applications. He has completed more than 290 mission critical laboratory, clinical, and manufacturing software implementation projects, and has written 5 books on CSV subject matter.

Topics Discussed:

An explanation of what CSV entails and why it’s so important in highly regulated industries…

Understanding 21 CFR Part 11 regulation and guidance, and the confusion it often creates for many companies…

6 Common Problems:

1 - required systems

2 - software requirements

3 - other resources that can be insufficient or inappropriate

4 - vendor responsibilities

5 - Traceability is a HUGE factor in terms of FDA expectations during audits

6 – the lack of appropriate SOPs

David Nettleton, and co-author Janet Clough, recently released a new technical book Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates a systematic, step-by-step approach for validating configurable off-the-shelf software that generates data or controls information about products and processes subject to regulations. With the purchase of this useful guide you will also receive access to templates the authors have used as training tools for more than 1,000 companies and components of more than 300 validation projects. David is also the author of the following books which can be purchased through the PDA bookstore, or by clicking the links below:

1. Risk-Based Software Validation-Ten Easy Steps (Out of Stock)

2. Managing the Documentation Maze

3. Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

4. Commercial Off the Shelf Software Validation for 21 CFR Part 11 Compliance (Out of Stock)

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes Brian Nunnally, Global Head of Quality Control – A CSL Company, to the show. Today, Stacey and Brian discuss how pharmaceutical manufacturers deal with unexpected variabilities over the lifecycle of their product.

• What is the current guidance?

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes Garlan Adams to the show to discuss how risk, compliance, and corporate culture matter.

• What is a culture of compliance?

Garlan Adams is an Executive Advisor/Consultant specializing in Legal, Regulatory, Risk, Compliance, and Corporate Culture matters.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes Ferdi Steinmann & Jennifer Wemstrom from OpenText to the show to discuss Enterprise Information Management and how companies are adapting to a new digital age.

Visit: www.opentext.com

• How can EIM help companies achieve supply chain flexibility?

Ferdi has nearly 25 years driving strategy & commercialization efforts in Biotech, Pharma, and Enterprise Software with Fortune 500 Co’s such as Merck & Co, Eli Lilly & Biogen. Ferdi’s focus is in Life Sciences (LS) strategic planning and industry marketing efforts for enterprise software solutions at OpenText today. He is energized by strategies that deliver on their promises!

Jennifer Wemstrom spearheads the Life Sciences Business Unit group within OpenText. Mrs. Wemstrom’s chief responsibility is to develop enterprise content solutions for OpenText, specializing in the areas of Clinical, Regulatory and Quality systems, utilizing OpenText’s technology, including Documentum, Documentum D2, Captiva, and InfoArchive.  Jennifer joined EMC in September of 2013 and EMC was acquired by OpenText in January 2017.  Prior to EMC, Jennifer was the head of Product Strategy at CSC and played a key role in the sales and development of CSC’s Documentum-based ECM product, FirstDoc®. With twenty five years of experience as a solution specialist and consultant in OpenText and other computer systems specifically related to the life science industry, Jennifer is an expert in systems supporting the management of regulatory, clinical, and quality documentation, creation of regulatory submissions, electronic document publishing as well as system validation.  She has worked on dozens of content management implementation projects facilitating requirements workshops and training sessions within the pharmaceutical industry.  Her role at CSC also included leading the Life Sciences Presales Group, and she has performed and managed all aspects of the presales process such as vendor analysis, RFP response, product demonstrations and requirements mapping.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes back Alton Johnson to the show to discuss companies adopting appropriate technologies and the Internet of Things.

Reference Documents:

• Internet of Things Reference Materials - https://www.dropbox.com/s/f69vtmztael36ej/Podcast%20Visual%20References.pdf?dl=0

Alton Johnson is an industry leader and expert in pharmaceutical development, manufacturing, technology and business solutions.  In his current consulting role, he develops strategies and solutions for clients in the areas of new product development, manufacturing, digital transformation,  pharmaceutical technology, business development and compliance.  He has 30-plus years leadership experience at Pfizer across R&D, Technical Services, Innovation and Advanced Manufacturing Technology / Pharma 4.0. His extensive publications and presentations encompass Quality by Design, Risk Management, Knowledge Management, Validation, Process Analytical Technology, Continuous Processing and Pharma 4.0, for organizations including ISPE, DIA, PDA and AAPS. He has served in leadership roles for PhRMA, on the board of Smart Manufacturing Leadership Coalition, and as Chair of the Steering Committee for NIH sponsored Engineering Research Center.  

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes Alton Johnson to the show to discuss companies adopting appropriate technologies and the Internet of Things.

• Understanding and developing an interconnected enterprise system

Alton Johnson is an industry leader and expert in pharmaceutical development, manufacturing, technology and business solutions.  In his current consulting role, he develops strategies and solutions for clients in the areas of new product development, manufacturing, digital transformation,  pharmaceutical technology, business development and compliance.  He has 30-plus years leadership experience at Pfizer across R&D, Technical Services, Innovation and Advanced Manufacturing Technology / Pharma 4.0. His extensive publications and presentations encompass Quality by Design, Risk Management, Knowledge Management, Validation, Process Analytical Technology, Continuous Processing and Pharma 4.0, for organizations including ISPE, DIA, PDA and AAPS. He has served in leadership roles for PhRMA, on the board of Smart Manufacturing Leadership Coalition, and as Chair of the Steering Committee for NIH sponsored Engineering Research Center.  

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.