Application of a Quality Systems Approach to Pharmaceutical CGMPs - Option 2

Bethesda, MD
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This training course will help you define the concepts behind the application of the Quality Systems to drug operations and the specific elements as discussed in the FDA guideline: Management Responsibilities, Resources, Manufacturing Operations and Evaluation Activities as well at the requirements in the ICH Q10 guideline and how it compares to the FDA document.

During this training course, you will learn about quality system elements from a risk-based approach so that the specific requirements can be prioritized based on the highest impact to product quality; this prioritization scheme can be then applied during implementation. Activities include developing and implementing an effective plan for compliance that addresses these specific requirements: CAPA, internal audits, outsourcing management, risk management, knowledge management and change control.

  1. Explain the specific requirements of the elements within the quality systems and which areas require more attention based on the overall product quality impact
  2. Identify which elements will require a cultural change and overall management commitment for its implementation
  3. Conduct a gap analysis to determine your level of compliance and be able to prioritize recommendations based on the more critical gaps
  4. Apply different levels of CAPA, internal audits and supplier audits corresponding to the risk being addressed
Event Location
PDA Training and Research Institute
4350 East West Highway, Suite 110, Bethesda, MD Get Directions

Contact

Program Inquiries
Tel: +1 (301) 656-5900
Exhibition/Sponsorship Inquiries
David Hall
Tel: +1 (240) 688-4405
Training Course Inquiries
Tel: +1 (301) 656-5900
Registration Customer Care
Tel: +1 (301) 656-5900

Standard Pricing

Standard Member Price

$2,099

GovernmentMember Only

$1,259

Health AuthorityMember Only

$1,259

AcademicMember Only

$1,259

Non-Member

$2,519

See Qualifying Criteria for Member Types.

GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Day 1

Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.

PLEASE 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 Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD , USA

The following hotels are located near the training course location:

Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814

Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814

Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD 20814

DoubleTree by Hilton Hotel Bethesda
8120 Wisconsin Avenue
Bethesda, MD 20814


Please visit the hotel’s website for more information.

How to Get Here
By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.