The ICH Q10 Workshop Series: The Practical Approach to Sustainable Compliance
September 18 - 19, 2013 | Renaissance Washington DC Hotel | Washington, D.C.
Exhibition: September 18-19
The PDA/FDA Improving Investigations Workshop is designed to share current regulatory expectations, and deliver practical solutions to improve a crucial part of a compliant quality system.
U.S. FDA and industry experts will facilitate these sessions and share their ideas and experience.
Building on the successful ICH Q10 Pharmaceutical Quality System Workshop for Executive Management held in the Fall of 2012, this workshop is designed to deliver practical solutions to improve quality investigations.
Hear FDA specialists and industry experts speak about the root causes of poor investigations, making "lack of adequate investigations" a top inspection observation globally. They will share their insights on how to assess and conduct thorough investigations that lead to sustainable improvement to quality and compliance.
This workshop will be an unique opportunity for participants to engage in direct interactions with FDA and industry peers to ask questions and share best practices that will result in tangible, real life solutions that can be immediately applied in your daily activities.
Quality | Manufacturing | Regulatory Affairs | Technical Operations | Research & Development
Senior Managers | Quality Assurance/Control | Senior Scientists | Executive Management | Writers of Investigations | Technical Experts
Jason E. Brown
Senior Manager, Programs and Meetings
Tel: +1 (301) 656-5900 ext. 131
Manager, Registration and Customer Accounts
Tel: +1 (301) 656-5900 ext. 115
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160
Post Workshop Only
Post Workshop in Addition to Full Conference Purchase
All prices in US dollars.
Please read PDA's confirmation, substitution, refund and photo release policies for this workshop.
Please let us know if you have any special dietary requirement we may assist you with. Please contact us at firstname.lastname@example.org.
Please read: In the breakout sessions attendees will have a choice to work through one of three (Lab, Manufacturing or Supplier) examples of investigations. The same highly interactive approach will be followed for all three investigations and each session will build on the collective experience and creativity of the group. The combined outcome in the breakouts at each phase of the investigation will be gathered and condensed into points to consider when conducting investigations.
Registrants will receive a link to select their breakout session within a week of PDA confirming their registration for the workshop.
Once a registrant selects their topic, they will receive a confirmation of their selection for their records.
Renaissance Washington DC Hotel
999 9th Street NW
Washington, DC 20001
Phone: +1 (202) 898-9000
Rate: Single: $299.00, plus applicable state and local taxes.
Cut Off Date: Wednesday, August 21, 2013 (Availability may be limited. Requests will be processed on a first-come, first-served basis. Attendees staying within the PDA block will receive the conference rate.
PDA is excited to host the 2013 PDA/FDA Improving Investigations Workshop at the Renaissance Washington DC Hotel. A block of rooms have been reserved at the group rate of $299 single or double occupancy, plus applicable state and local taxes. Reservations must be secured by Wednesday, August 21, 2013, after this date, reservations can be made on a space and rate available basis only.
To make reservations at the Renaissance Washington DC Hotel, please call the Hotel at +1 (202) 898-9000 and reference the PDA/FDA to receive the PDA group rate. Check in time is 4:00 p.m., and check out time is 12:00 noon.
Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 6 p.m. on the date of arrival otherwise specified on your reservation information.
The Renaissance Washington DC Hotel is located in Penn Quarter; in the heart of downtown Washington DC. Local attractions include the National Portrait Gallery, Smithsonian Institute and Air Space Museum, Washington Monument, Capitol Hill, and many more. All 794 guest rooms and suites provide high-speed Internet, upgraded Luxurious bedding, coffee makers, hair dryers, iron and an ironing board.
Show your Badge for VIP Treatment
Show your Badge" is Washington DC's newest program designed just for you! Enjoy world-class restaurants, attractions and performing arts while you're in town. To participate, simply show your conference/convention badge to any of our participating partners and receive VIP treatment and exclusive discounts. More information on participating restaurants, attractions and transportation can be found in the click below:
Ronald Reagan Washington National (DCA), is approximately 5 miles away. Two other airports in the vicinity are both serviced by all major carriers: Dulles International (IAD) is 28 miles away and Baltimore/Washington (BWI) is 32 miles away.
Taxi fares from Reagan National are approximately $20 one way, not including tip, and will take about 20 minutes. One way taxi fares from Dulles is approximately $75 and from BWI is about $75.
Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.5 one way to Reagan National.
Union Station is 1 mile away from the hotel. To book your reservation call Amtrak at 1 (800) 872-7245 or visit http://www.amtrak.com. It is approximately $35 one way from the airport, to Union Station, to the hotel.
Renaissance Washington DC Hotel is located on 999 9th Street NW off of New York Avenue.
$33 / Daily Self Parking
$40 / Daily Valet Parking
High impact, cost-effective sponsorship and exhibition packages are available for the PDA Investigations Workshop. Gain on-site exposure and connect with industry experts from manufacturing, quality, senior management, compliance, and regulatory agencies. The workshop agenda provides ample time for exhibitors to make new contacts and network with attendees who will be seeking solutions and guidance on the root cause of poor investigations and how to assess and conduct thorough investigations. Exhibit at this workshop to gain new business relationships, connect with key players in the industry, and improve your sales. In addition, comprehensive sponsorship packages will provide your company the opportunity to strengthen brand image, increase visibility, and reinforce its commitment to the biopharmaceutical industry. Sponsorships are also available for lanyards, USBs, notepads, pens, refreshment breaks, lunch, and networking reception.