PDA Annex 1 Workshop 2024
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Individual Registration
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Call for Posters
By submitting your scientific poster you will join our poster walk and gain more visibility.
Deadline: 20 September 2024
Learn More Poster SubmissionsDear Colleagues,
The PDA is delighted to announce the return of our esteemed event, the PDA Annex 1 Workshop 2024, scheduled to take place on 05-06 November 2024, in the vibrant city of Dublin, Ireland.
This workshop is designed to educate and support the industry in adapting to the revised EU GMP Annex 1. At PDA, we remain steadfast in our commitment to providing scientifically rigorous, practical, and technical information, along with training programs that contribute to the advancement of science and regulation for both our members and the broader industry.
Workshop Objectives:
Address Challenges: The primary goal of the workshop is to tackle the challenges and implications associated with the revised EU GMP Annex 1.Critical Changes: We will delve into specific sections, ensuring attendees gain a comprehensive understanding of how to successfully navigate the requirements of the updated Annex.
Engage and Learn: Attendees will have the invaluable opportunity to hear insights from industry experts and regulators, and interactive sessions will foster open discussions among peers, allowing for the sharing of challenges and best practices.
Standardized Approach: PDA has established a standardized approach to workshop topics, ensuring that the information disseminated to the industry remains consistent and pertinent to the current regulatory landscape.
We eagerly anticipate welcoming you to this enriching event!
Sincerely,
The Co-Chairs
Fred Ayers, ValSource
Tracy Moore, TM Pharma Group
SCIENTIFIC PROGRAM PLANNING COMMITTEE:
- Fred Ayers, ValSource
- Tracy Moore, TM Pharma Group
- Marcia Baroni, EBSI
- Laura Brennan, Ecolab
- Francesco Cicirello, BioNTech
- Paolo Curto, DOC Validation
- Richard Denk, SKAN
- Derek Duncan, LIGHTHOUSE Instruments
- Maria Ginnelly, BMS
- Kurt Jaecques, GSK
- Amanda McFarland, ValSource
- Patrick Nieuwenhuizen, PharmaLex
- Jessie Lindner, PDA
- Falk Klar, PDA Europe
- Sabine Hartmann, Manager Programs & Events, PDA Europe
Event Location
Contact
Program Inquiries
Exhibition/Sponsorship Inquiries
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Registration Customer Care
Early Registration
Register by 08 September 2024
Member Price
€ 2.050GovernmentMember Only
€ 980
Health AuthorityMember Only
€ 980
Early Career ProfessionalMember Only
€ 980
StudentMember Only
€ 980
AcademicMember Only
€ 980
Non-Member
€ 2.350
Standard Registration
Register after 08 September 2024
Member Price
€ 2.250GovernmentMember Only
€ 1.080
Health AuthorityMember Only
€ 1.080
Early Career ProfessionalMember Only
€ 1.080
StudentMember Only
€ 1.080
AcademicMember Only
€ 1.080
Non-Member
€ 2.550
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
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Read BioFrederic B. Ayers
ValSource, Inc.
Frederic B. Ayers
ValSource, Inc.
Fred, a 1999, graduate of Franklin College of Indiana with a Bachelor of Arts (B.A.) in Biology. While at Franklin College he was a 4-year student-athlete and participated in the institution's Leadership Program. After graduating, he spent time in the contract manufacturing industries, prior to joining Eli Lilly in 2001. Mr. Ayers has held various roles within the Quality and Technical Services organizations. In each position Fred has helped advance Lilly's state of regulatory compliance and is regarded as a global Sterility Assurance Subject Matter Expert. For Lilly–Indianapolis Parenteral Manufacturing, he had the responsibility of the development, implementation, and continuous improvement for all aspects of the site's sterility assurance program. As an Advisor for the Global Quality Standards organization, Fred was responsible for ensuring that Lilly Quality Standards for the Sterility Assurance Programs evolve with global regulatory expectations. Currently, Fred provides consultation services to the pharmaceutical and biopharmaceutical industries, specializing in Contamination Control, Sterility Assurance, and Microbiology. He is driving technical leadership through external focus and engagement throughout the bio-pharmaceutical industry to influence the direction of regulatory expectations. Fred has been a strong supporter of PDA has a Board Member since 2014 (President from 2020-2021) including a Task Force Member for PDA Technical Report 90. Fred is a committee member for many workshops and conferences, and a standing member of the PDA Scientific Advisory Board. -
Read BioMarcia C. Baroni, MBA
Vice President Enterprise GxP Compliance & Systems, Emergent BioSolutions
Marcia C. Baroni, MBA
Emergent BioSolutions
With over 20 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Enterprise GxP Compliance & Systems for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for GxP Compliance and Global Quality Systems across Emergent's organization. Marcia is a Microbiologist (University of Toronto) and holds an MBA from Purdue University. -
Read BioLaura Brennan
European Technical Consulting Leader, Ecolab
Laura Brennan
Ecolab
Laura Brennan has previously worked as a Pharmaceutical Microbiologist, primarily with the manufacture of terminally sterilized products. She has also worked with government run agencies, monitoring and ensuring environmental microbiological standards are being maintained. Laura is a European Technical Consulting Leader on Ecolab’s Life Sciences contamination control expert team. She has worked for Ecolab Life Sciences for several years and has held various roles within the technical consulting team. In her current role, she leads the European Technical Consulting Team. Her team are responsible for delivery of technical consulting in the areas of Cleanroom cleaning & disinfection, Cleaning in Place (CIP) and Hydrogen Peroxide Vapour (HPV) Bio-decontamination. Her team support clients in several areas such as review of existing regimes in line with regulatory expectation, troubleshooting specific issues, corrective and preventative actions, validation and general technical enquiries. Laura routinely presents on contamination control topics at industry seminars across the world. -
Read BioFrancesco Cicirello, PharmD, MSc
Senior Director Quality Compliance, BioNTech
Francesco Cicirello, PharmD, MSc
BioNTech
Francesco Cicirello is Senior Director, Quality Compliance at BioNTech US. Before joining BioNTech, Francesco worked in a Regulatory Agency. He was an Expert Inspector at the Therapeutic Good Administration (TGA in Australia. He was elected to several roles in PIC/S including Chairperson of the Working Group revising the PIC/s Annex 2 and Deputy Chair of the Subcommittee on Harmonisation. Francesco represented PIC/S at the EMA IWG and was member of the PIC/S Coordinating Committee on the Human Blood, Tissues, Cells & ATMPs. -
Read BioRichard Denk
Senior Consulting Aseptic Processing & Containment, SKAN AG
Richard Denk
SKAN AG
Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 15 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2021 Richard has spent more than 30 years with the subject production of aseptic processing and highly active / highly hazardous substances and has developed the containment pyramid. -
Read BioDerek I Duncan, PhD
Director Product Lines, LIGHTHOUSE Instruments
Derek I Duncan, PhD
LIGHTHOUSE Instruments
Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into the industry holding various Product & Application Development positions. Currently at LIGHTHOUSE and based in Amsterdam since 2003, Dr. Duncan is responsible for developing applications for pharmaceutical process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection. Dr. Duncan has been a PDA member since 2004 and has been a regular contributor to PDA conferences, IG Groups, and Conference Program Committees. -
Read BioKurt Jaecques, MA
Global Aseptic Technologies Lead Monitoring & Control, GSK
Kurt Jaecques, MA
GSK
Kurt Jaecques is the Global Aseptic Technologies lead for Monitoring and Control at GSK and has been working within the pharmaceutical Industry for more than 30 years. He holds a Master's degree in Biochemistry and has been working in different QC and QA Roles with focus on pharmaceutical Microbiology in general and Environmental Monitoring, Bioburden Controlled Manufacturing and clean Utilities in particular. He co-chaired the update of the PDA TR13 on Environmental Monitoring and is PDA IG co-lead for Microbiology and Environmental Monitoring. -
Read BioAmanda McFarland, MS
Senior Consultant, ValSource, Inc.
Amanda McFarland, MS
ValSource, Inc.
Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and co-lead of the Kilmer Regulatory Innovation team. She has a BS in entomology and an MS in mycology, both from the University of Florida. She can be contacted at [email protected]. -
Read BioTracy Moore
Director, TM Pharma Group Ltd
Tracy Moore
TM Pharma Group Ltd
Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, QP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines. -
Read BioPatrick Nieuwenhuizen, MSc
PharmaLex Ireland
Patrick Nieuwenhuizen, MSc
PharmaLex Ireland
Director Senior Consultant with PharmaLex Ireland. Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked in various Quality roles for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Vaccines and Solid Oral Dose. Qualified lead auditor and SME in Quality Control, Sterility Assurance and New Facility Design/Upgrade. Risk facilitator for Quality Risk Management programs and gained significant experience with problem-solving and management of complex investigations. Co- author of the PDA Technical Report for “Contamination Control Strategy” and Edufarma’s education program “Farmaceutisch Vakman (Pharmaceutical Professional). Patrick holds a Master in Pharmaceutical Microbiology form the University of Manchester.
Sponsorship and Exhibit Opportunities are available!
For more information about exhibit and sponsorship opportunities, please contact:
Christopher Härtig
Senior Manager Exhibition & Sponsorship
Email
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Request InformationPLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
PDA recommends the reservation at the following hotel
Crowne Plaza Dublin - Blanchardstown
Blanchardstown Town Centre
Dublin, D15 T1FD
Ireland
PDA Europe has reserved a limited number of rooms until the 1st of October 2024.
Book your room at the PDA Group Rate via the above-mentioned reservation button.
How to Get Here
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Of course, you can also book through your IATA travel agency. The travel agency can request the ticketing instructions by sending an email to [email protected], stating the event code DEAPIBJ.
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Event Ticket one-way and specific train (subject to availability):
- 1st class 89,90€ (seat reservation incl.)
- 2nd class 55,90€
Event Ticket one-way and fully flexible:
- 1st class 112,90€ (seat reservation incl.)
- 2nd class 77,90€
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