Falls Church, VA (PRWEB) March 31, 2015
Thomas Peither and Bernhard Gotter — two of the industry’s most respected inspection readiness professionals — will conduct a one-of –a –kind workshop that walks attendees through the inspection process.
Attendees will learn exactly what motivates an FDA or national authority investigator and what they look for when conducting an inspection.
Their techniques include interactive role-playing exercises and roundtable discussions. This will assure attendees are fully prepared for their next inspection — whether it’s a pre-approval, scheduled or for-cause inspection.
Specifically attendees will learn:
- What is the basis for an inspection
o The similarities and differences between the various national authorities
o The top 10 issues cited in FDA and PIC/s observations and why they occur
o The diversity of regulatory inspections in Europe
- How to prepare for an inspection
o How to manage the language hurdle
o How to set up a world class back office — one that improves efficiency and productivity
o Ways to demonstrate GMP compliance throughout the company
o How to research an investigator and interpret past work and signs
o How to set up the perfect inspection team for a company
- How to behave during an inspection
o How to use role playing to prepare for an investigators arrival
o How to react when an investigator identifies an observation
o What’s important to object to and what organizations should accept
- What happens after the inspection
o How to respond to inspection observations including — FDA 483s and warning letters
o How to create and properly maintain a remediation plan
o How to communicate the findings to the organization
Who Will Benefit:
- QA/QC managers and directors
- Compliance personnel
- Regulatory affairs professionals
- Production managers
- Production supervisors
- Quality inspection and test managers
- Process development staff
- Training managers
- Purchasing Agents involved in outsourcing production or processes
- Recall coordinators
- General/corporate counsel
Meet the Instructors:
Thomas Peither — Thomas Peither is the founder and CEO of Peither & Consultants GmbH. Thomas has over 20 years of GMP consulting experience working with some of the world’s largest pharmaceutical and biotech companies. He is a sought-after expert in all facets of cGMP. Plus, he’s recognized as a sought-after speaker who provides expert insights into current developments within the field of GMP. Peither & Consultants prides itself on focusing on customer satisfaction by identifying the needs of its customers using a proven programmatic approach. Thomas is also a co-director of Maas & Peither AG — also known as GMP Publishing. Given his international experience, he has been invited to be involved with numerous high-level initiatives within various national and international professional organizations. Thomas is a long term member of PDA and ISPE, co-publisher of the GMP MANUAL and author of several other GMP publications. Thomas studied mechanical engineering at the Technical University of Munich and achieved his diploma in 1990.
Bernhard Gotter — Bernhard Gotter, Ph.D. studied pharmaceutical science at the Martin-Luther-University in Halle, Germany. After his studies he did a Ph.D. in a biopharmaceutical research group. In 2011 Bernhard entered the pharmaceutical industry at the Bayer site in Grenzach. There he started as a QA associate with responsibilities in audit and inspection management, supplier management, change control and qualification and validation activities. During that time he managed several audits and inspections of the site by the ANVISA, Taiwan FDA, Saudi Arabia FDA, Gulf Corporation Council, German authorities and several customer audits. Since 2013 he has led a FDA readiness project which prepares the site for an FDA pre-approval-inspection of a sterile medicinal product.
GMP Inspections in Europe: Proven Strategies on How to Prepare Investigations
**Presented by FDAnews and Peither & Consultants GMBH**
June 10-11, 2015 – Frankfurt, Germany
Significant team discounts are available.
Easy Ways to Register
By phone: 888-838-5578 or 703-538-7600
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.