ºÝºÝߣ

hipaa compliance hipaa privacy rule flsa compliance training fair labor standards act flsa compliance ich and usp requirements analytical test methods validation analytical methods validation fda analytical method validation fmla compliance usp compliance training ofac regulations ofac compliance export controls compliance acceptable documents immigration law form i-9 receipt rule hipaa security rule cyber fraud detection anticyber fraud act federal regulations good documentation practices family and medical leave act information security training document forgery osha compliance sec filing conflict minerals compliance enterprise risk management aml compliance sec disclosures sec guidance on conflict minerals it security training pharmaceutical manufacturing cleanroom cleaning i-9 retention cleanroom operations microbial control mhra regulations iso 13485 imb bioburden control. fda qs regulation internal auditing contamination control product contact surfaces personnel practices gowning fda ema common i-9 mistakes process equipment disaster recovery internal controls export administration regulations current good manufacturing practices erm gap analysis business continuity fda 510k training anti-fraud controls fda 510k submissions fda 510k submission requirements bsa compliance erm compliance bsa training medical device recalls osha inspection hipaa breach notification rule hipaa security rule compliance hipaa compliance training hipaa risk assessment breach notification hipaa privacy hitech act post-market surveillance requirements ce marking applications aimd (active implantable medical device directive) notified body (nb) selection medical device coordination group (mdcg) eu mdd 2012/0266 (cod) european medical devices directive 93/42/eec directive 2007/47/ec microbial control training water system contamination good laboratory practices basics of fmla compliant handling and recall terms. fda part 803 compliant handling and reporting inadequate compliant handling fda part 806 compliant handling process compliant handling pitfalls compliant handling warning letters qc laboratory data laboratory analysis data management fda documentation practice laboratory data management laboratory systems fda documentation requirement laboratory data base computerized documentation computerized data management 21 cfr part 11 for laboratory m5 version of the mdd amendment to 93/42/eec mdd (medical device directive) ivdd (in vitro diagnostic device directive) direct microbial test methods form 806 common mistakes in recall voluntary recall program correction report health hazard evaluation process cdrh recall process drug products shipping and distribution clinical research clinical site audit quality assurance training and education site monitoring qa programs clinical trial failure portfolio risk management risk mitigation strategic planning portfolio optimization pharmacogenomics and patient safety fda regulation of pharmacogenomics fda guidance for pharmacogenomics pharmacogenomics data challenges in pharmacogenomics applications of pharmacogenomics pharmacogenomics regulation osha compliant respiratory program 29 cfr 1910.134 regulations respirator protection program respiratory protection standards respirator protection program template respiratory protection plan osha respiratory protection standard types of respirators removal report silent recall regulatory enforcement market withdrawal investment portfolio theory recover insurance underwriting losses clinical research compliance clinical trial regulations clinical trial compliance quality improvement methods clinical research regulations inspection documentation fda gcp requirements good clinical practices compliance fda guidelines fda gcp inspections inspection follow-up procedures gcp regulations emea water system requirements microbial monitoring training water system design compliance training fda water system regulations microbial enumeration purified water systems fda regulations drug development models capacity planning drug development project management optimal portfolio selection drug development portfolio planning drug development risk simulation portfolio risk analysis portfolio simulation insurance management rational insurance risk framework risk reduction risk transfer economics cost/benefit framework risk transfer insurance reduction insurance deductibles risk retention insurance financial portfolio hipaa security rules performance reviews employee evaluations hr compliance employee coaching legal compliance performance evaluations performance management employee reviews performance appraisals entertainment reimbursement internal procurement frauds corporate credit card abuse" reimbursement fraud expense reimbursement fraud-audit techniques travel reimbursement cma roles cma clinical monitoring ich guidelines clinical monitor assistant cma responsibilities. clinical trials team gcp guidelines patient communications risk analysis portable devices hipaa challenges smart phones corporate compliance grc audits and inspections duties of a compliance officer corporate compliance officer compliance toolkit responsibilities of a compliance officer enterprise compliance program fraud prevention accounts payable fraud ap fraud fraud detection it security compliance laboratory control system quality control laboratory fda 483 citations system based inspections fda inspections osha records osha citations osha fines safety documents inspection plan inspection process types of osha inspections hipaa policies hipaa audit protocol hipaa audit process arra 2009 hhs ocr workplace probes employment law compliance workplace investigations handling harassment investigations hr policy training workplace bullying workplace harassment investigation labor law compliance training human resources training superiority study objectives non-inferiority trials superiority trials fda guidance for ni trials equivalence clinical study design statistical interpretation ni trials hypothesis tests employee abuse fmla for small business fmla eligibility fmla qualifying events serious health condition for fmla federal family and medical leave act integration of fmla military family leave provision fmla employer compliance changes to fmla fmla insurance risk security rule social media risk assessment faa ac 21-43 faa requirements parts manufacturer approvals pah pma production approval holder pma quality system advisory circular faa order 8120.2 14 cfr part 21 subpart k biomaterials supplier liability supplier risk supplier liability device supplier risk supplier protection for finished device biomaterials for medical devices device supplier liability device component supply risk liability protection for raw material suppliers general supplier liability fda regulations for biomaterials supplier specialty chemicals biomaterials access assurance act of 1998. choosing workplace investigator hr compliance training employee harassment aml compliance program aml risk assessment training anti-money laundering document control good documentation requirements gdp training program good documentation practices training gender discrimination sexual orientation sex harassment gender identity workplace discrimination gender discrimination laws sexual stereotyping post-interview evaluation reading body language medical device manufacturers fda qsr and iso13485 free trade zones training program free trade area and free trade zone global trade concepts training sec new whistleblower rules training fraud-related whistleblower protections sec's revised whistleblower program compliance audit grc program grc audit grc program design risk audit governance financial fraud red flags financial fraud detection best practices fda inspection compliance electronic records compliance fda regulations compliance training phase 1 ind cgmp phase 1 ind regulations phase 1 drugs compliance phase 1 ind studies gmp auditor in pharma companies gmp auditor roles and responsibilities pharmaceutical gmp auditing gmp compliance training export compliance training essentials of export controls office of foreign asset controls us economic sanctions americans with disabilities act internal investigation eeo compliance investigation strategy preclinical studies documentation errors fda requirements manufacturing activities documenting data documentation omissions data chain-of-custody clinical studies debit card fraud liability of financial institution liability of accountholder regulation e requirements training program fda electronic records regulations and breach notification regulations hipaa enforcement hipaa security audits hipaa privacy audit security gxp compliant excel spreadsheets develop and validate excel spreadsheets excel spreadsheet validation 21 cfr part 11 compliance loss prevention strategies loss prevention program retail loss detection training conducting shrink investigation theft indication hipaa gap analysis hipaa documentation over-the-counter drugs adverse event reporting requirements dietary supplements otc products social media management program preventing social media risks social media policy social media training program federal sentencing guidelines crisis management erm program erm checklist fmla best practices avoiding employment litigation fmla and ada overlap issues fmla and ada training program internet and privacy protection internet of things i-9 errors ocaho immigration and customs enforcement i-9 form immigration compliance training notice of inspection lgbtqia compliance lgbt workers rights training program lgbt employer legal obligations lgbtqia employees smart grid capability optimization clean power plans compliance training clean power plans training program 111(d) rule components fda qsr fda consent decree training schering plough consent decree consent decree training program fda regulatory guidance dietary supplement health and education act fda dietary supplements training fda regulations for marketing dietary supplements inbound marketing marketing training program content marketing marketing and social media banking and marijuana federal and state laws cannabis industry state laws risk model in aml/bsa program handling security breaches training privacy in the digital age training hipaa osha regulations osha compliance training osha safety training osha audits osha jurisdiction osha safety inspections fda vaccine approval process fda vaccine guidance potency testing of vaccines fda vaccine vaccine regulations fda vaccine regulations us custom compliance us import rules import trade compliance record keeping import trade compliance conflict of interest fabricated clinical data clinical trial fraud prevention clinical research fraud falsified clinical data ich regulatiuon for clinical laboratories ich gcp for ema ich gcp for fda compliance ich requirement for clinical laboratories ich rules for clinical laboratories fda regulation off-the-shelf drugs marketing otc products ofccp compliance office of federal contract compliance programs eo 11246 quality risk management ich q9 risk management tools patient safety regulatory inspections pharmaceutical quality glp for food labs food lab accreditation glp in food manufacturing ssop for food laboratory equipment calibration in food labs requirements for food testing labs federal initiatives in pharmacogenomics biomarkers pharmacogenomic testing pharmacogenomics and ethical issues cbp approval for record keeping record keeping rules recordkeeping requirements recordkeeping policies record keeping training electronic record keeping rules safety training safety committee guidelines safety committee goals safety committee committee activities federal osha requirement state safety laws safety committee purpose safety plan iso 14971 interviewing sophisticated criminals financial fraud investigations effective interviewing skills forensic accounting financial auditing conducting effective interviews detecting deception genetic information nondiscrimination act gina hipaa regulations dispute resolution settlements settlement finality benefits of settlement types of settlement types of leverage bsa suspicious activity report bank secrecy act reporting requirements bank secrecy act compliance training bank secrecy act compliance aml regulatons anti money laundering traning aml training fda regulations for drugs cgmps eu pharmaceutical regulatory requirements eu pharmaceutical regulations european regulatory environment dcaa audit requirements dcaa audit training dcaa guidelines usda national organic program usda regulations organic labeling & marketing organic cosmetics regulations usda compliance ear compliance export control self- assessment export control program itar compliance hipaa privacy protections hipaa compliance requirements hipaa compliance deadline software verification and validation fda 21 cfr part 11 compliance fda software verification fraud in clinical research non-standard settlement terms standard settlement terms release of claims settlement negotiation strategy foodborne contamination food borne pathogens monitoring foodborne microbes microbial contamination food safety compliance hazard identification permit to work system health and safety compliance workplace safety hse incidents workplace hazards risk assessments genetic tests