Aim of this training course is to facilitate a deeper understanding and provide insights into the Aseptic Processing environment, and to go beyond what is commonly covered in books on that subject. A practical
and highly interactive approach will enable participants to get actively involved, discussing guidelines and
Warning Letters in addition to sharing perspectives and solutions to issues found in everyday job situations.
A kaleidoscope of hot topics such as Best Practices and Case Studies from different areas of Aseptic Processing, Sterile Production facilities, QA/ QC Microbiology Control, Shop Floor Mentoring and Oversight will be addressed. Training and Motivation of staff, use of Risk Assessments and Quality Culture are further relevant aspects.
Lively interactions will make this a valuable learning experience for all.
Who Should Attend
Personnel involved in Aseptic Processing from sterile production departments such as:
- Production Management and Shop Floor Supervisors
- QA and QC Microbiologists
- Qualified Persons
- Personnel from technical department
A basic understanding of Aseptic Processing is a prerequisite.
- Gain deeper knowledge and insights into specific topics like sterilization, training and motivation of shop-floor staff, correct aseptic working practices, media fill worst case criteria, effective environmental monitoring programs, good cleaning & disinfection practices, etc.
- Understand key requirements and challenges in parenteral production
- Understand the importance of a good quality culture within a company
- Apply the executed and presented case studies and team exercises in her/his daily job
- Get answers and interpretations about - potentially - unresolved questions and problems
- Gain confidence for audits
Guenther Gapp, PhD, Independent Consultant, Gapp Quality GmbH
Since 2013, the microbiologist Guenther Gapp has been working as an independent consultant for different clients around the globe, and has been engaged in more than 30 projects: recently at US- Lachman Consultants as “Aseptic Processing Expert”, e.g. in assignments for remediation of companies cited with a Warning letter. In the previous steps of his career, he served in the pharmaceutical industry during 20 years as Head of QA/QC Microbiology department and Sterility Assurance Expert and Troubleshooter in global projects and supplier audits. During this period, he gained in-depth experience in Aseptic processing key elements, Training and motivation of operators, media fill practices of finished dosage forms and bulk products, environmental monitoring, rapid testing methods and regulatory agency audits. Guenther has been a subject matter expert in more than 20 FDA audits. He also created a new sterile risk assessment tool to identify and reduce the microbial contamination and compliance risk of aseptically prepared, sterile products, and this method is used now worldwide. The publication of this Risk Assessment tool won him the 2011 PDA Journal of Pharmaceutical Science and Technology Award. He has been a speaker at several PDA conferences in the past years. Since 2017 he is also a member of the 2017 PDA Annex 1 Workshop committee and Task Force, which deals with the revision of the important European guidance Eudralex Annex 1 “Manufacture of Sterile Medicinal Products”.