Montgomery, TX

Senior Consultant Ryan Murray is attending this event.

Palm Springs, CA

Several ValSource team members are participating in this event.

New York City, NY

Several ValSource team members are participating in this event.

Charleston, SC

Consultant Amanda Curtis is attending.

Dallas, TX

Vp, Business Development Brian Jordan and Safety Director Patrick Monahan are attending.

Las Vegas, NV

Senior Consultant Patrick Mains is attending.

San Francisco, CA

ValSource VP, Business Development Brian Jordan and Regional Manager Walter Henkels are attending.

San Diego, CA

Senior Consultant Ryan Murray is presenting at the event.

Washington, DC

Business Unit Manager Kelly Waldron and Senior Consultant Stacey Largent are attending this event.

Copenhagan, Denmark

Director of Learning Solutions Jim Vesper, PhD, is co-teaching this course.

Louisville, CO

Senior Consultant Amanda McFarland is speaking on, “Quality Risk Management in Action: Driving Contamination Control Strategies Forward.” ValSource is also sponsoring the event.

Cambridge, MA

Senior Consultant Darius Pillsbury is speaking on the topic of, “The Only Constant in Life is Change: Utilizing a Science-driven and Risk-based Approach to Speed Process Changes for ATMPs.” Consultant Beth Fulton is attending.

Virtual

Director of Learning Solutions Jim Vesper, PhD, is co-teaching this free live webinar.

Raleigh, NC

Senior Consultants Kim Sobien, Amanda McFarland and James Wamsley are attending this event.

Copenhagan, Denmark

Director of Learning Solutions Jim Vesper, PhD, is teaching this course.

Edmonds, WA

Senior Consultant Tiff Baker and Consultant Virginia Andreotti-Jones are presenting at this event.

New Paltz, NY

ValSource Regional Manager John Sorrentino, Validation Consultant Devin Deodat, and Senior HR & Benefits Administrator Kristen Gallagher are attending.

Basking Ridge, NJ

Regional Manager John Sorrentino is attending.

Online & Ahmedabad, India

Senior Consultant Amanda McFarland is presenting on the topic of, “Exploring the Relationship Between Contamination Control Strategies and Quality Risk Management.”

Durham, NH

ValSource Regional Manager Jon Belliveau is attending.

Raleigh, NC

ValSource Regional Manager Matt Mudalel is attending.

Raleigh, NC

VaSource VP, Operations Matteo Taormina and Regional Manager Matt Mudalel are attending.

King of Prussia, PA

Regional Manager John Sorrentino is attending.

Worcetser, MA

ValSource Regional Manager Jon Belliveau and Validation Engineer Michael Fraser are attending.

Durham, NC

Multiple ValSource members are attending the event.

Newark, NJ

ValSource VP, HR, and Recruiting Carl Barnett, Regional Manager Joe Russo, and Validation Engineer Connor Welts are attending.

Greenville, NC

ValSource Regional Manager Matt Mudalel is attending.

Troy, NY

ValSource Regional Manager John Sorrentino is attending.

Cary, NC

Several ValSource members are attending this event.

Oro Valley, AZ

ValSource Safety Director Patrick Monahan and PIMSHQ COO John Moehnke are attending.

Bethesda, MD

ValSource is a sponsor of this event.

Villanova, PA

ValSource VP, HR, and Recruiting Carl Barnett, Regional Manager Joe Russo, and Validation Engineer Connor Welts are attending.

Orlando, FL

Several ValSource team members are participating in this conference.

San Francisco, CA

Regional Manager Walter Henkels, Senior Consultant Patrick Mains, and Project Manager Kabo Ng are attending the event.

Seattle, WA

ValSource is a sponsor of this event.

Philadelphia, PA

Regional Manager John Sorrentino is attending this event.

Raleigh, NC

Senior Consultant Kim Sobien is attending the event.

Carlsbad, CA

Virtual

ValSource Senior Consultant Darius Pillsbury is a member of the planning committee.

San Francisco, CA

ValSource Senior Consultant Patrick Mains and Consultant Virginia Andreotti-Jones are attending the event.

Montreal, Quebec

Senior Consultant Tiffany Baker is teaching this training course.

Basking Ridge, NJ

Senior Consultant Darius Pillsbury is attending.

Philadelphia, PA

Senior Consultants Darius Pillsbury and Ryan Murray are attending this event.

Kenmore, WA

Senior Consultant Amanda McFarland is a panelist and Consultant Virginia Andreotti-Jones is moderating the discussion at this event.

Houston, TX

ValSource Safety Director Patrick Monahan is attending this event with John Moehnke from our partner software company, PIMSHQ.

Raleigh, NC

ValSource is a sponsor of the event.

Munich, Germany & Online

Senior Consultant Igor Gorsky is presenting at the event.

Berlin, Germany

Senior Consultant Stephen Langille, PhD, is presenting at the event.

Philadelphia, PA

ValSource Senior Stacey Largent is attending the event.

Dublin, Ireland

ValSource Senior Consultants Fred Ayers and Amanda McFarland are presenting and members of the planning committee.

Costa Rica

ValSource Director, Learning Solutions James Vesper will be speaking and moderating the event.

La Jolla, CA

ValSource team members are attending this event.

Chapel Hill, NC

Senior Consultant Patrick Mains is presenting at the event.

Virtual

Director, Learning Solutions James Vesper, PhD, MPH is instructing the course.

San Diego, CA

Safety Director Patrick Monahan, and PIMSHQ COO John Moehnke will be attending this event.

Phoenix, AZ

ValSource team members are attending this event.

Malvern, PA

VP, Business Development Brian Jordan and Regional Managers Joe Russo and John Sorrentino are attending this event.

Indianapolis, IN

Consultant Virginia Andreotti-Jones is presenting and VP, Business Development Brian Jordan is attending the event.

Orlando, FL

Several ValSource team members are attending this event.

Melbourne, Australia

Senior Consultant Kim Sobien is presenting at the conference.

Washington, DC

ValSource Business Unit Manager Marc Glogovsky will be serving on the planning committee.

Phoenix, AZ

ValSource Business Unit Manager Kelly Waldron and Senior Consultants Ryan Murray, Tiffany Baker, and Darius Pillsbury are attending this event.

Washington, DC

ValSource team members are participating in this event.

Raleigh, NC

Senior Consultant Amanda McFarland is presenting at this event.

Foxboro, MA

Several ValSource team members are attending this event.

Dublin, OH

VP, Business Development Brian Jordan is attending.

New Brunswick, NJ

Regional Manager John Sorrentino and Safety Director Patrick Monahan are attending the event.

San Carlos, CA

Regional Manager Walter Henkels, Senior Consultant Patrick Mains, Consultants Virginia Andreotti-Jones and Lindsay Matern are attending this event.

Ijamsville, MD

Validation Project Manager Matt Hausman and Regional Manager John Weisgerber are attending the event.

Cuyahoga Falls, MI

VP, Business Development Brian Jordan and Director of Metrology Andrew Hooper are attending this event.

Bethesda, MD

Consultant Collin Wyse is attending this conference.

Philadelphia, PA

ValSource Senior Consultant Jessica Chiaruttini is speaking at this event and Business Unit Manager Marc Glogovsky is attending.

Bethesda, MD

Senior Consultant Patrick Mains is co-teaching

Washington, DC

Senior Consultant Stephen Langille is presenting and Consultant Amanda Curtis is on workshop planning committee and presenting.

Washington, DC

Several ValSource team members are attending this conference.

Somersworth, NH

Vice President, Business Operations Matteo Taormina, Regional Manager Jon Belliveau and Senior CQV Engineer Brendan Sullivan are attending this event.

Rockville, MD

ValSource Business Unit Manager Marc Glogovsky and Consultant Sussanah Davis are attending this conference.

Cambridge, MD

ValSource Director, Learning Solutions James Vesper will be speaking.

Denver, CO

VP, Business Development Brian Jordan is attending this event.

Durham, NC

Stop by table 26 to connect with VP, Business Development Brian Jordan.

San Diego, CA

ValSource Safety Director Patrick Monahan will be attending this conference.

Fredrick, MD

ValSource is sponsoring this program. Registration deadline is 6/10/2024.

Amsterdam, The Netherlands

Several ValSource team members are participating in this event.

Durham, NC

Several ValSource team members are participating in this event.

Philadelphia, PA

ValSource VP, Business Development Brian Jordan, Empire Regional Manager John Sorrentino are attending this event.EPREX Director John Molaskey will also be attending.

Malvern, PA

Regional Manager John Sorrentino will be attending this event.

Boston, MA

Several ValSource team members are attending this conference. Look for us at BOOTH #416.

Rockville, MD

ValSource Consultant Virginia Andreotti-Jones is facilitating this meeting, Senior Consultant Tiffany Baker and Unit Manager Kelly Waldron will be in attendance.

Rockville, MD

ValSource Consultant Virginia Andreotti-Jones is facilitating this meeting, Senior Consultant Tiffany Baker and Business Unit Manager Kelly Waldron will be in attendance.

San Diego, CA

VP, Business Development Brian Jordan is attending this event.

Virtual

Senior Consultant Igor Gorsky is presenting.

Stuttgart, Germany

ValSource Senior Consultant Amanda McFarland is presenting at this event.

Northbrook, IL

Senior Consultant Paula Peacos is presenting, VP, Business Development Brian Jordan, Western Regional Manager Walter Henkels and Director of Metrology Andrew Hooper will be attending this conference.

Virtual

ValSource Director of Learning Jim Vesper, PhD, is teaching this workshop.

Baltimore, MD

ValSource Business Senior Consultants Tiffany Baker and Darius Pillsbury, and Consultant Beth Fulton are presenting posters. Business Unit Manager Kelly Waldron is attending.

Philadelphia, PA

Senior Consultants Amanda McFarland and Steve Langille are speaking at this workshop.

Baltimore, MD

ValSource Director of Metrology Andrew Hooper, Regional Manager John Weisgeber and Validation Project Manager Matt Hausman are attending this event.

Chapel Hill, NC

VP, Business Development Brian Jordan, Senior Consultant Darius Pillsbury, and other ValSource team members are attending this event.

New York, NY

ValSource VP, Business Development Brian Jordan, Business Unit Manager Marc Glogovsky, Empire Regional Manager John Sorrentino, Mid-Atlantic Regional Manager Joe Russo, and EPREX Procurement & Expediting Director John Molaskey will be attending this event.

Tampa, FL

ValSource Director of Learning Solutions Jim Vesper, PhD, is presenting at this conference.

Virtual

Senior Consultant Stacey Largent will be presenting the program titled, “Pitfalls of Quality Risk Management and Risk Assessments,” and the tutorial, “Risk Ranking & Filtering: A Customizable Tool for Making Risk-based Decision.”

Montgomery, TX

VP Business Development Brian Jordan, Regional Manager Walter Henkels, and Senior Consultant Ryan Murray will be at this event.

Long Beach, CA

ValSource Senior Consultants Kim Sobien, and Consultants Beth Fulton, and Val Canning be attending this event.

Long Beach, CA

Board of Directors: Business Unit Manager Marc Glogovsky. Program Planning Committee & Moderators: Senior Consultants Amanda McFarland and Ryan Murray. Presenting: COO Hal Baseman, Senior Consultants Kim Sobien, Jessica Chiaruttini, Steven Langille, Kim Sobien, Amanda McFarland and Consultant Beth Fulton. Attending: VP, Business Development Brian Jordan, Business Unit Manager Kelly Waldron, Director of Learning Solutions James Vesper, Senior Consultants Fred Ayers, Tiffany Baker, Igor Gorsky, Stacey Largent, Patrick Mains, and Consultants Amanda Curtis, James Wamsley, Theo Zacharatos, Angelica Welch

Long Beach, CA

ValSource Consultant Beth Fulton will be attending this event.

Raleigh, NC

Look for ValSource at Booth #135. Vice President of Business Development Brian Jordan will be attending this event.

Tucson, AZ

ValSource’s partner company PIMSHQ is sponsoring this conference. PIMSHQ COO John Moehnke and ValSource Senior Consultant Arthur Limper are presenting a special educational breakout session on safety. ValSource Vice President of Business Development Brian Jordan, EPREX Director John Molaskey, and Senior Marketing Director Dorsey Manning will also be in attendance. Stop by Booth #4 to learn more and meet the team.

Cary, NC

Join ValSource Senior Consultants Amanda McFarland and Kim Sobien, Regional Manager Matt Mudalel, and Project Manager Jared Wine at this PDA Southeast Chapter networking event  on Tuesday, Feb.13 from 5:30-7:30PM at Fortnight Brewing Company in Cary, NC.

Foster City, CA

ValSource Senior Consultant Fred Ayers is speaking during the mid-morning panel on the topic of Annex 1.

Seattle, WA

Vice President of Business Development Brian Jordan and Regional Manager Walter Henkels will be in attendance.

Miami Beach, FL

ValSource Business Unit Manager Kelly Waldren, PhD; Senior Consultants Darius Philsbury and Ryan Murray; VP of Business Development Brian Jordan and Senior Marketing Director Dorsey Manning will be attending this conference.

Miami Beach, FL

ValSource Business Unit Manager Kelly Waldron, PhD; Senior Consultants Darius Pillsbury and Ryan Murray; Vice President of Business Development Brian Jordan; and Senior Marketing Director Dorsey Manning will be attending.

Seattle, WA

ValSource Vice President of Business Development Brian Jordan will be attending this event.

Online

ValSource Senior Consultant Tiffany Baker is co-teaching this live e-learning course.

Carlsbad, CA

This hands-on training course is being taught by ValSource Business Unit Manager Marc Glogovsky.

Charlotte, NC

ValSource Senior Consultants Fred Ayers, Co-Chair; Amanda McFarland; and Kim Sobien are scheduled to speak at the workshop; ValSource Consultant Angie Welch will be in attendance.

Charlotte, NC

ValSource Senior Consultant Fred Ayers is a Co-Chair of this workshop and a moderator. ValSource Senior Consultants Amanda McFarland and Kim Sobien are presenting; ValSource Consultant Angie Welch will be in attendance.

Online

ValSource Senior Consultant Amanda McFarland is presenting on the topic of, “Quality Culture: The Mindset, The Benefits, and the PDA Quality Culture Assessment .”

Naples, FL

ValSource is joining PIMSHQ at the Construction Users Roundtable (CURT) Members Meeting and Safety & Wellness/Workforce Development Summit in Naples, FL.

Antwerp, BE

ValSource Senior Consultant Fred Ayers is a Co-Chair of this workshop, moderating and speaking. ValSource Senior Consultant Amanda McFarland is moderating and presenting.

Incheon, South Korea

ValSource Business Unit Manager Marc Glogvosky, Director of Learning Solutions Jim Vesper, PhD, and Senior Consultant Amanda McFarland will be presenting.

Durham, NC

Senior Consultants Amanda McFarland and Kim Sobien are moderating sessions; SE Regional Manager Matt Mudalel will be in attendance.

Indianapolis, IL

ValSource Senior Consultant Tiffany Baker will be presenting on the topic of, ”Developing an Optimized Risk Assessment Portfolio – The Quality Risk Management Master Plan.” ValSource Consultant Jessica Chiaruttini, PhD, will be speaking on the topic of, “What’s Objectionable? A Risk-Based Approach to Determine Objectionability of Microorganisms in Non-Sterile Dosage Forms.” ValSource VP of Business Development Brian Jordan and Regional Manager Walter Henkels will also be attending this event.

Berlin, Germany

ValSource Senior Consultant Igor Gorsky is presenting at the Vonlanthen Group of Companies 2nd Cleaning Validation & HPAPI Manufacturing Conference in Berlin, Germany October 25-26 on the topic of, “Science and Risk Based Approach for Cleaning Validation.”

Virtual

ValSource Senior Consultant Stephen Langille, PhD, will be speaking on the topic of microbial contamination in non-sterile drug products.

Virtual

ValSource Senior Consultant Stephen Langille, PhD, is presenting on the topic of microbial contamination in non-sterile drug products.

Malvery, PA

ValSource VP of Business Development Brian Jordan and Regional Managers Walter Henkles and John Sorrentino are attending.

Gothenburg, Sweden

Business Unit Manager Marc Glogovsky is attending.

Las Vegas, NV

The following ValSource team members are attending the 2023 ISPE Annual Meeting: VP of Operations Matteo Taormina; VP of Business Development Brian Jordan; Business Unit Manager Kelly Waldren, PhD; Senior Consultant Stacey Largent; Senior Consultant Patrick Mains; Senior Consultant Paula Peacos; Senior Consultant Ryan Murray; Consultant Beth Fulton; Senior Marketing Director Dorsey Manning.

Cuyahoga Falls, OH

ValSource Metrology Director Andrew Hooper is attending.

Washington, DC

Senior Consultant Fred Ayers is presenting and moderating, Business Unit Manager Marc Glogovsky is Co-Chair of the workshop and will be moderating; Senior Consultants Kim Sobien and Paula Peacos are moderating, and Consultant Amanda Curtis is participating in the workshop.

Washington, DC

Presenting: Business Unit Manager Marc Glogsovsky; Senior Consultants Stephen Langille, PhD; Fred Ayers; Consultant Amanda Curtis.
Attending: Senior Consultants Paula Peacos and Kim Sobien; Consultants Jessica Chiaruttini, PhD; Christine Craig, PhD; and James Wamsley.

Virtual conference

ValSource Senior Consultant Igor Gorsky is presenting at the Uventia 3rd Annual HPAPIs: Containment & Handling Summit 2023 virtual conference September 28-29, 2023 on the topic of, “Science and Risk-Based Approach for Cleaning Validation.

Gillette Stadium, Foxborough, MA

ValSource is looking forward to the ISPE Boston Area Chapter Product Show. ValSource VP of Operations Matteo Taormina, Northeast Regional Manager John Belliveau, and EPREX Director of Procurement & Expediting John Molaskey will be in attendance in addition to several other team members.

Boston, MA

ValSource Senior Consultant Tiffany Baker will be attending this event.

Washington, DC

Presenting: Director of Learning Jim Vesper, PhD; Senior Consultants Amanda McFarland; Stephen Langille, PhD; and Fred Ayers.

Moderating: Business Unit Manager Marc Glogovsky

Also Attending: Business Unit Manager Kelly Waldren, Senior Consultants Igor Gorsky; Ryan Murray; Darius Pillsbury, PhD; Tiffany Baker; Consultants Virginia Andreotti-Jones, James Wamsley, and Heather Hafer-DeMilto.

Schedule a Meeting

Philadelphia, PA

Join Valsource at the 2023 PharmaEd Microneedle & Intradermal Delivery Forum. Consultant Jessica Chiaruttini will be presenting on the topic of,“Microbiological Control for Intradermal Products: A Former Regulators Perspective.” ValSource Vice President of Business Development Brian Jordan will also be in attendance.

Schedule a Meeting

London, England

The 16th World Drug Delivery Summit on Pharmaceutics is on September 6-7, 2023 in London, England. ValSource Consultant Jessica Chiaruttini will be presenting in Track 20 on the topic of, “Navigating Regulatory Expectations for Microbiological Control of Microneedle Products.”

Mumbai, India

ValSource Senior Consultant Igor Gorsky is speaking on the topic of “Science and Risk Based Approach for Cleaning Validation” at the EBM 3rd Annual Cleaning Validation 2023 conference in Mumbai, India.

Singapore

The 2023 PDA Pharmaceutical Manufacturing & Quality Conference entitled “The Way Forward: Trends, Technologies and New Regulations Transforming Pharmaceutical Manufacturing” is taking place on August 15 & 16, 2023 in Singapore. Don’t miss our Senior Consultant, Kim Sobien, speaking on the topic of Micro Strategy for CCS.

Cambridge, MD

ValSource Director of Learning Solutions James Vesper, PhD, MPH is co-presenting Workshop 3: GMP101: An Overview of the Drug Product CGMPs. Topics will include Historical context of the US CGMPs, Characteristics of CGMP-compliant products, Seven essentials of GMPs, and Challenges in meeting the essentials.

San Diego, CA

Join Walter Henkels, Manager, Western Region; Brian Jordan, VP, Business Development; and Patrick Mains, Senior Consultant, at the ISPE San Diego Chapter meeting on June 29, 2023. The topic is “Manufacturing Best Practices: The Journey from Clinic to Commercialization.”

Dublin, Ireland

ValSource Consultants are headed to the upcoming 2023 ISPE Biotechnology Conference in Dublin, Ireland on June 27-28. Senior Consultant Darius Pillsbury will be presenting, “2B or not 2B? Readiness for the PPQ of a Cell Therapy.”

Baltimore, MD

The PDA Advanced Therapy Medicinal Products Conference is taking place June 7-8 in Baltimore, MD. Don’t miss Darius Pillsbury, Senior Consultant, PDA ATMP Advisory Board member, and Cell & Gene Therapy Interest Group Lead’s moderating the session, “Manufacturing Process Design and Implementation: A Risk-Based and Science-Driven Approach and Ryan Murray, Senior Consultant, presenting the session, “A New PDA Points to Consider Document in the Making: Materials for ATMP Manufacturing”.

Bothell, WA

This discussion organized by the Pacific Northwest Chapter of the PDA & led by ValSource’s own Virginia Andreotti-Jones will focus on Risk Management Strategies and a portfolio of risk assessments that can be used to support a robust contamination control strategy.

Philadelphia, PA

Join the region’s most recognized experts as they share knowledge of breakthrough technologies and the latest regulations.

San Francisco, CA

Connect with ValSource at the PDA West Coast Chapter: 2023 Women in Life Science- Panel Discussion. All team members will be in attendance and we hope to see you there!

St. Paul, Minnesota

Amanda McFarland, Senior Consultant QRM and Microbiology and James Wamsley, Consultant – Microbiology will be presenting this course.

Barcelona, Spain

This 2-day workshop is scheduled for May 9-10, 2023 with ValSource team members presenting in Barcelona, Spain & online.

Philadelphia, PA

Find ValSource team members, Brian Jordan, John Weisgerber & Andrew Hooper at ASQ’s World Conference on Quality & Improvement. This conference will dig into topics including supply chain delays, economic pressure, sustainability, and global volatility.

Northbrook, IL

ValSource is headed to the PDA Midwest’s 15th Annual Microbial Contamination and Control Conference May 3-4 in Northbrook, IL. Stop by the ValSource exhibit booth #11 to connect with Brian Jordan and don’t miss Business Unit Manager Marc Glogovsky’s presentation “PDA TR 88 – Microbial Data Deviation Investigations In the Pharmaceutical Industry.”

Online

ValSource Learning Solutions & WCG FDAnews presents a virtual workshop entitled “Effective Root Cause and CAPA Investigations for Drugs, Devices and Clinical Trials.”

New York, NY

No matter where you are in the pharmaceutical supply chain, INTERPHEX delivers relevant solutions through curated education sessions, networking and over 500 global suppliers to source quality product and services.

Philadelphia, PA

Don’t miss your opportunity to network with ValSource team members, Brian Jordan, Joe Russo. We look forward to meeting you at AAPS National Biotechnology Conference!

Alachua, FL

Look for Brian Jordan, ValSource VP of Business Development at BioFlorida: 2023 Celebration of Biotechnology!

New Orleans, LA

Join ValSource instructors, Marc Glogovsky, Amanda McFarland, Patrick Mains, and James Wamsley.

New Orleans, LA

Join Amanda McFarland, ValSource Senior QRM Consultant and PDA co-chair at the 2023 PDA Annual Meeting in New Orleans, LA — April 3-5.

Foster City, CA

Whether you are producing biologic drug substance, conducting sterile fill-finish operations, or entering into cell and gene therapy, this meeting will provide the latest information to help your organization have the knowledge and agility needed to meet the needs of the patients we serve.

North Bethesda, MD

Amanda McFarland, Senior QRM Consultant at Valsource is speaking at the 2023 ISPE Aseptic Conference, March 6-7 2023 in North Bethesda, MD.

Raleigh, NC

Join us for the 2023 PDA Contamination Control Strategies Workshop — March 1 & 2 in Raleigh, NC.

Raleigh, NC

You’re invited to the 2023 PDA Annex 1 Workshop — Feb 27 & 28 in Raleigh, NC.

Raleigh, NC

See you at the ISPE CaSA 30th Annual Life Sciences Technology Show – Feb 28, 2023 at the Raleigh, NC Convention Center!

San Antonio, TX

This year’s theme: “Construction in a VUCA World: Volatility | Uncertainty | Complexity | Ambiguity”.

Dallas, TX

In this one-day training course with ValSource’s own, Jim Vesper, participants will examine regulatory expectations regarding investigations where people are involved in the deviation, models and tools used in the transportation industry. They will also learn how the brain and certain actions can set up a person to make a mistake.

2022 Annual Environmental Monitoring Training Program – A Practical Approach to Design, Qualification and Implementation of a Robust and Compliant Environmental Monitoring and Trending Program with Paula Peacos

Darius Pillsbury (Senior Consultant) and Stephen Langille (Senior Microbiology Consultant) Presentation: Are You Ready for Annex 1? Points to Consider When Doing an Annex 1 Self-Assessment — A Comprehensive Review of Annex 1 History, Revisions and the Latest Draft to Ensure Readiness for Annex 1 Compliance & Understanding Its Potential Global Regulatory Impact

Stephen Langille, Ph.D. (Senior Microbiology Consultant) Presentation — Burkholderia cepacia Complex Organisms: The New General Chapter USP Microbiological Examination of Non-Sterile Products Tests for Burkholderia cepacia Complex & FDA’s Position on Bcc.

Scheduled December 7 at 10 am PRT/9 am EST, James Vesper a member of the VS consulting team, will be presenting “An Example of Using a Risk-Based Approach for Data Integrity.” His presentation will discuss: When do you “verify” an action? What does “verify” really mean? How does verify compare to actions like review or check? This presentation looks at what the US, EU, and PIC/S Good Manufacturing Practice regulations say about confirming that an action or activity has taken place using a risk-based approach that supports data integrity.

Discover novel approaches and best practices for tackling current industry contamination control challenges at the 4th Annual SMi Pharmaceutical Microbiology West Coast (Virtual) Conference.

Ensure compliance when you transform your root cause analysis and corrective and preventive action (CAPA) investigations. Join James Vesper, Director, ValSource Learning Solutions, on a discussion exploring risk-based alternatives when a definitive root cause can’t be determined.

Learn ways to conduct better investigations and corrective actions. This workshop examines a defined, logical process that can be applied to investigations that are performed in the drug, biotech, and medical device industries.